Date Initials Comments

Transcription

1 Month 03 Data Processing Cover Sheet ID. No.: - Alpha Code: Visit: 03 FORMS NOTES Check all forms completed: Ocular Surface Disease Index (OSI) Brief Ocular Discomfort Inventory (ODI) Follow-up Health Review Form (FR) Follow-up Dietary Supplement Form (FS) Dry Eye Treatment Form (DT) MMP-9 Testing Form (MM) Follow-up Visual Acuity (VA) Follow-up Ocular Evaluation Form (OA) If needed: Concomitant Medication Log (CM_Log) Adverse Event Log (AE_Log) Review Completed CRFs Entry Complete Date Initials Comments 06/17/2014

2 OCULAR SURFACE DISEASE INDEX (US English version of the OSDI) OSI (003.1) 02/21/2014 Page 1 of 1 Please answer the following questions by checking the box that best represents your answer. Have you experienced any of the following during the last week: All of the time Most of the time Half of the time Some of the time None of the time 1 Eyes that are sensitive to light? 2 Eyes that feel gritty? 3 Painful or sore eyes? 4 Blurred vision? 5 Poor vision? Have problems with your eyes limited you in performing any of the following during the last week: All of the time Most of the time Half of the time Some of the time None of the time Not applicable 6 Reading? 7 Driving at night? 8 Working with a computer or bank machine (ATM)? 9 Watching TV? Have your eyes felt uncomfortable in any of the following situations during the last week: All of the time Most of the time Half of the time Some of the time None of the time Not applicable 10 Windy conditions? 11 Places or areas with low humidity (very dry)? 12 Areas that are air conditioned? Copyright 1995 Allergan, Inc.

3 BRIEF OCULAR DISCOMFORT INVENTORY (BODI ) ODI (002.1) 04/09/2014 Page 1 of 2 1. Please rate your ocular discomfort by circling the one number that best describes your ocular discomfort at its worst in the last week No Discomfort as bad as Discomfort you can imagine 2. Please rate your ocular discomfort by circling the one number that best describes your ocular discomfort at its least in the last week No Discomfort as bad as Discomfort you can imagine 3. Please rate your ocular discomfort by circling the one number that best describes your ocular discomfort on the average in the last week No Discomfort as bad as Discomfort you can imagine 4. Please rate your ocular discomfort by circling the one number that tells how much ocular discomfort you have right now No Discomfort as bad as Discomfort you can imagine Please continue to the next page

4 BRIEF OCULAR DISCOMFORT INVENTORY (BODI ) ODI (002.1) 04/09/2014 Page 2 of 2 Circle the one number that describes how during the past week ocular discomfort has interfered with your: 5. General Activity Does not Completely Interfere interferes 6. Mood Does not Completely Interfere interferes 7. Walking Ability Does not Completely Interfere interferes 8. Normal work (includes both work outside the home and housework) Does not Completely Interfere interferes 9. Relations with other people Does not Completely Interfere interferes 10. Sleep Does not Completely Interfere interferes 11. Enjoyment of life Does not Completely Interfere interferes 12 In the last week, how much relief have ocular treatments or medications provided? Please circle the one percentage that most shows how much relief you have received. 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% No Complete Relief Relief

5 FOLLOW-UP HEALTH REVIEW FR (021.3) 08/07/2016 Page 1 of 4 1. Does the patient report taking study supplements per protocol (5 pills/day)? 1A. Has the patient discontinued taking all study supplements? (specify reasons, and continue with question #2) a. Developed contraindication to omega 3 ( ) 1 Record on AE Log b. Physician recommendation ( ) 1 c. Patient unable to tolerate side effects ( ) 1 d. Other (Specify below) ( ) 1 (ask question 1B) 1B. Does the patient take some, but less than 5 study supplements per day? (specify reasons) a. Physician recommendation ( ) 1 b. Patient unable to tolerate side effects ( ) 1 c. Other (Specify below) ( ) 1 2. Ask the patient if they have developed any of the following conditions since the last DREAM study visit: No Yes a. Atrial Fibrillation 0 1 b. Hemophilia, thrombocytopenia or other bleeding issues 0 1 c. Liver disease 0 1 d. Uncontrolled ocular or systemic disease 0 1 e. Started taking an anti-coagulant such as Warfarin, Coumadin, Jantoven, Marevan, Uniwarfin, 0 1 Heparin or Warf? Instruct patient to discontinue study supplements. Record on AE Log and if required, on the CMED log.

6 FOLLOW-UP HEALTH REVIEW FR (021.3) 08/07/2016 Page 2 of 4 3. Are there any prescriptions or over-the counter (OTC) medications that have been started, discontinued, or changed since the last DREAM study visit? Update the Concomitant Medication Log. 4. Has the patient used antihistamine eye drops since the last study visit? Update the Concomitant Medication Log. 5. Is the patient currently taking omega-3, EPA, DHA, or ALA fatty acids or Vitamin E? Do not include DREAM study supplements Complete the Dietary Supplement Form. 6. Since the last DREAM visit or scheduled call, have you had any new symptoms, injuries or side effects or worsening of pre-existing conditions, or been diagnosed with illnesses such as Sjögren s Syndrome or thyroid disease? Record on the Adverse Event Log.

7 FOLLOW-UP HEALTH REVIEW FR (021.3) 08/07/2016 Page 3 of 4 7. Since the last DREAM visit or scheduled call, have you have any health event which required major medical intervention or hospitalization? Record on the Adverse Event Log. 8. Are there any events listed on the adverse event log that were unresolved as of the previous contact? Ask the patient about any unresolved AEs on the Adverse Event Log and update accordingly. 9. Return of DREAM bottles and gelcaps a. Number of returned supplement bottles b. Number of returned gelcaps 10. Has the address where the patient should receive study drug changed since their last shipment? Complete a Patient Change of Address Form for IDS and fax to the Investigational Drug Service

8 FOLLOW-UP HEALTH REVIEW FR (021.3) 08/07/2016 Page 4 of 4 11a. Print last name of staff completing this form: b. Certification #: 12. Date this form completed / / 201 Month Day Year

9 FOLLOW-UP DIETARY SUPPLEMENT FORM ID. No.: - Alpha Code: Visit: FS (029.1) 04/23/2014 Page 1 of 1 Instructions: Information must be obtained during the follow-up visit (months 03, 06, 12, 18 and 24) by reviewing the ingredient labels of all dietary supplements taken by the patient so that the dose can be accurately recorded. If a multivitamin is taken, review and list the dose of the specific ingredients listed below. Add the doses from separate bottles (if applicable) and record the total daily dose for each of the supplements listed below. DO NOT INCLUDE THE DREAM STUDY SUPPLEMENTS ON THIS FORM! 1. Total daily dose of Ω-3 Fatty acids (do not include ALA: Alpha- Linolenic Acid) a. EPA + mg b. DHA + mg c. Ω-3 Fatty acid, (if breakdown of EPA/DHA is not given) + mg d. Sum of 1a., 1b., and 1c. = mg Note: Only enter a value for 1c if EPA and DHA values are not listed individually on the supplement labels. 2. Total daily dose of ALA mg 3. Total daily dose of Vitamin E iu 4. Last name and certification number of person who completed this form a. PRINT last name: b. Certification #: 5. Date Form Completed / / Month Day Year

10 DRY EYE TREATMENT DT (011.2) 05/26/2015 Page 1 of 4 Instructions: This form is to be completed by the DREAM Clinic Coordinator by directly questioning the patient at every in-office study visit beginning with the month 03 Visit. 1. Have you used artificial tears or gel in the last week? a. About how many times a day did you use tears or gel? (check one) ( ) times ( ) times ( ) times ( ) 4 greater than 10 times 2. Have you used lubricating ointment in the last week? a. About how many times a day did you use lubricating ointment? (check one) ( ) 1 1 time ( ) 2 2 times ( ) 3 3 times ( ) 4 greater than 3 times 3. Have you used any of the following over-thecounter treatments for dry eye in the last week? a. Lid scrubs b. Baby Shampoo c. Warm Lid soaks d. Other OTC treatments 1. Specify, other:

11 DRY EYE TREATMENT DT (011.2) 05/26/2015 Page 2 of 4 4. Have you used Restasis in the last week? a. How many times per day did you use Restasis in each eye? (check one for each eye) Right eye Left eye None ( ) 0 ( ) 0 1 time ( ) 1 ( ) 1 5. Have you used autologous serum eye drops in the last week? 6. Have you used other eye drops in the last week? 2 times ( ) 2 ( ) 2 3 times ( ) 3 ( ) 3 > 3 times ( ) 4 ( ) 4 a. Check which eye drops were used (check all that apply) ( ) 1 a. Steroid eye drops ( ) 1 b. Antibiotic eye drops ( ) 1 c. Allergy eye drops ( ) 1 d. Combination Steroid and Antibiotic eye drops ( ) 1 e. Other specify: 7. Have you used prescription pills for dry eye such as doxycycline, Oracea, Vibramycin, Doryx or Monodox in the last week? If yes, check which pills were used ( ) 1 a. Doxycycline ( ) 1 b. Tetracycline ( ) 1 c. Minocycline ( ) 1 d. Oracea ( ) 1 e. Monodox ( ) 1 f. Vibramycin ( ) 1 g. Other pills for dry eye, specify:

12 DRY EYE TREATMENT DT (011.2) 05/26/2015 Page 3 of 4 8. Do you have punctal plugs in place? 9. Do you have a Prokera amniotic membrane device in place? 10. Have you used Lacriserts in the last week? 11. Have you used LipiFlow or intense light treatment in the last week? 12. Have you used any other treatment for dry eye In the last week? a. If yes, specify:

13 DRY EYE TREATMENT DT (011.2) 05/26/2015 Page 4 of Last name and certification number of person who completed this form a. PRINT last name: b. Certification #: 14. Date Form Completed / / Month Day Year

14 MMP-9 TESTING MM (028.2) 05/26/2015 Page 1 of 1 ID. No.: - Alpha Code: Visit: INSTRUCTIONS: MMP-9 testing is performed at Screening and at month 03. All measurements must be done by the DREAM technician or clinician certified for this procedure. 1. Patients allergic to cornstarch or Dacron should not be tested. Was MMP-9 testing completed at this visit? Record the results below. Read any form of a red line, whether faint, broken, or shadow, as a positive test result. A. Right Eye Test Result ( ) 1 Positive ( ) 0 Negative B. Left Eye Test Result ( ) 1 Positive ( ) 0 Negative C. Why was MMP-9 testing not done? 1. Allergy to cornstarch or Dacron ( ) 1 2. Ocular infection in last 90 days ( ) 1 3. Patient refusal ( ) 1 4. Other (Specify below) ( ) 1 2. Last name & certification number of person who performed testing (or person who completed this form if testing was not completed): a. Print Last Name: b. Certification #: 3. Date of Exam (or date form completed if testing was not completed) / / 201 Month Day Year

15 Follow-up Visual Acuity Testing VA (023.1) 04/08/2014 Page 1 of 2 NOTE: Best corrected visual acuity is measured at months 03, 06, 12 (18 and 24). The refractive correction from the most recent manifest study refraction should be used for testing visual acuity. Circle each correct letter and put an X on each incorrect letter. Leave letters not attempted unmarked. 1. Subjective refraction used for VA testing (If Plano, enter zeros): Right Eye: + /. + /. X (Circle Sign) Sphere (Circle Sign) Cylinder Axis 2. Letters read correctly at 3.2-meter (10 feet, 6 inch) distance: RIGHT EYE - CHART 1 Acuity Number Equivalent Chart 1 Letters Correct a. 20/200 N C K Z O b. 20/160 R H S D K c. 20/125 D O V H R d. 20/100 C Z R H S e. 20/80 O N H R C f. 20/63 D K S N V g. 20/50 Z S O K N h. 20/40 C K D N R i. 20/32 S R Z K D j. 20/25 H Z O V C k. 20/20 N V D O K l. 20/16 V H C N O m. 20/12.5 S V H C Z n. 20/10 O Z D V K o. Total number correct If total number correct is 10 or more letters LESS than the previous study VA, perform manifest refraction and repeat VA testing

16 Follow-up Visual Acuity Testing VA (023.1) 04/08/2014 Page 2 of 2 3. Subjective refraction used for VA testing (If Plano, enter zeros): Left Eye: + /. + /. X (Circle Sign) Sphere (Circle Sign) Cylinder Axis Letters read correctly at 3.2-meter (10 feet, 6 inch) distance: LEFT EYE - CHART 2 Acuity Number Equivalent Chart 2 Letters Correct a. 20/200 D S R K N b. 20/160 C K Z O H c. 20/125 O N R K D d. 20/100 K Z V D C e. 20/80 V S H Z O f. 20/63 H D K C R g. 20/50 C S R H N h. 20/40 S V Z D K i. 20/32 N C V O Z j. 20/25 R H S D V k. 20/20 S N R O H l. 20/16 O D H K R m. 20/12.5 Z K C S N n. 20/10 C R H D V o. Total number correct 4. Last name and certification number of person who performed testing If total number correct is 10 or more letters LESS than the previous study VA, perform manifest refraction and repeat VA testing a. PRINT last name: b. Certification #: 5. Date Form Completed / / Month Day Year

17 FOLLOW-UP OCULAR EVALUATION FORM OA (016.2) 05/26/15 Page 1 of 12 BEFORE COMPLETING THE OCULAR EXAMINATION, YOU MUST BE ABLE TO ANSWER YES TO THE FOLLOWING QUESTIONS: Have you done MMP9? (Month 03 only) The Following are done at Month 06, Month 12, Month 18, Month 24: Have you done Tear Osmolarity? (Centers with TearLab Osmometer) Have you done Keratography? (Centers with Oculus Keratograph) Have you done BCVA? if >10 letter change must redo manifest refraction. Have you done Contrast Sensitivity? Have you done Tear Cytokine Collection? (Centers with -80 C freezer) ITEMS 1 THOUGH 28 MUST BE PERFORMED BY THE CLINICIAN ONLY! 1. Conjunctiva Erythema (bulbar) Right Left None (normal) ( ) 0 ( ) 0 Mild (flush reddish color) ( ) 1 ( ) 1 Moderate (more prominent red color) ( ) 2 ( ) 2 Severe (definite redness) ( ) 3 ( ) 3 2. Conjunctiva Edema (bulbar) Right Left None (normal) ( ) 0 ( ) 0 Mild (slight localized swelling) ( ) 1 ( ) 1 Moderate (moderate/medium localized ( ) 2 ( ) 2 swelling or mild diffuse swelling) Severe (severe diffuse swelling) ( ) 3 ( ) 3 Very Severe (very prominent/ protruding diffuse swelling) ( ) 4 ( ) 4 3. Anterior Chamber Cells (Slit beam 0.3 mm wide, 1.0 mm long) Right Left Grade 0 (<1 cells in field) ( ) 0 ( ) 0 Grade 0.5 (1-5 cells in field) ( ) 1 ( ) 1 Grade 1+ (6-15 cells in field) ( ) 2 ( ) 2 Grade 2+ (16-25 cells in field) ( ) 3 ( ) 3 Grade 3+ (26-50 cells in field) ( ) 4 ( ) 4 Grade 4+ (>50 cells in field) ( ) 5 ( ) 5

18 FOLLOW-UP OCULAR EVALUATION FORM OA (016.2) 05/26/15 Page 2 of Anterior Chamber Flare (Slit beam 0.3 mm wide, 1.0 mm long) Right Left Grade 0 (None) ( ) 0 ( ) 0 Grade 1+ (Faint) ( ) 1 ( ) 1 Grade 2+ (Moderate; iris & lens ) ( ) 2 ( ) 2 details clear) Grade 3+ (Marked; iris & lens) ( ) 3 ( ) 3 details hazy) Grade 4+ (Intense: fibrin or plastic) ( ) 4 ( ) 4 Aqueous 5. Tear Film Debris Right Left None (absent) ( ) 0 ( ) 0 Mild (present in inferior tear meniscus) ( ) 1 ( ) 1 Moderate (present in inferior tear meniscus ( ) 2 ( ) 2 and in tear film overlying cornea) Severe (present in inferior tear meniscus ( ) 3 ( ) 3 + and in tear film overlying cornea. Presence of mucus strands in inferior fornix or on bulbar conjunctiva) 6. Lid Margin Debris (evaluate upper and lower eyelid) Right Left Normal (0 collarettes) ( ) 0 ( ) 0 Mild (1-5 collarettes) ( ) 1 ( ) 1 Moderate (6-20 collarettes, ( ) 2 ( ) 2 a few fragments) Severe (21-40 collarettes, 1-2 clumps) ( ) 3 ( ) 3 Very severe (40+ collarettes; > 3 clumps) ( ) 4 ( ) 4

19 FOLLOW-UP OCULAR EVALUATION FORM OA (016.2) 05/26/15 Page 3 of Eyelid Margin Erythema (redness & neovascularization of lid margin upper and lower eyelid) Right Left Normal ( ) 0 ( ) 0 Mild ( ) 1 ( ) 1 Moderate ( ) 2 ( ) 2 Severe ( ) 3 ( ) 3 8. Lid Foam (soapy look along lower eyelid margin Right Left Yes ( ) 1 ( ) 1 No ( ) 0 ( ) 0 9. Lashes Right Left Normal ( ) 1 ( ) 1 9a1. Specify right eye abnormality: Abnormal ( ) 0 ( ) 0 9b1. Specify left eye abnormality: 10. Eye lid skin Edema Right Left None (normal) ( ) 0 ( ) 0 Mild (localized to a small region of the lid) ( ) 1 ( ) 1 Moderate (diffuse, most/all lid but not prominent/protruding) ( ) 2 ( ) 2 Severe (diffuse, most or all lid AND prominent/protruding) ( ) 3 ( ) 3 Very Severe (diffuse AND prominent/protruding AND reversion of the lid) ( ) 4 ( ) 4

20 FOLLOW-UP OCULAR EVALUATION FORM OA (016.2) 05/26/15 Page 4 of Chalazion present on any eyelid? Right Left No ( ) 0 ( ) 0 Yes ( ) 1 ( ) Facial skin: rosacea: No ( ) 0 Yes ( ) 1 TEAR BREAK UP TIME RIGHT EYE Instructions Instill 5 µl of fluorescein 2% in the right eye. Allow patient to blink a few times. Wait 30 seconds after instillation. Measure the TBUT 3 times using a digital stopwatch within 1 minute of instillation. If the TBUT is >20 seconds, just record 20.0 seconds. 13. Time of drop instillation Right Eye: : AM/PM Hr Min circle one Wait 30 seconds after instillation before recording TBUT. 14. Record TBUT time Right Eye (USE STOPWATCH): 14a. 1st measure:. secs 14b. 2nd measure:. secs 14c. 3rd measure:. secs WAIT 2 MINUTES BEFORE PERFORMING CORNEAL STAINING EVALUATION OF THE RIGHT EYE

21 FOLLOW-UP OCULAR EVALUATION FORM OA (016.2) 05/26/15 Page 5 of 12 CORNEAL STAINING FLUORESCEIN RIGHT EYE Instructions Corneal staining must be performed approximately 2.5 minutes after fluorescein instillation. Allow patient to blink a few times. Use a yellow barrier filter with a cobalt blue illumination. Score each section from Grade Fluorescein staining Grade (0-3) Right Eye Grade Grade 15a. Top Top 0 15b. Center 1 15c. Temporal Temporal Center Nasal 2 15d. Bottom 15e. Nasal Bottom Filamentary Keratitis Right Eye No ( ) 0 Yes ( ) 1

22 FOLLOW-UP OCULAR EVALUATION FORM OA (016.2) 05/26/15 Page 6 of Other Corneal Abnormality Right Eye No ( ) 0 Yes ( ) 1 17A. Specify Abnormality Right Eye: a. Corneal infiltrates ( ) 1 b. Corneal abrasion ( ) 1 c. Corneal ulcer ( ) 1 d. Neovascularization ( ) 1 e. Other (Specify below) ( ) 1 ( ) Meibomian Gland Evaluation (Right Eye): Plugging USE THE MGE with mild pressure/depress shaft about half way (evaluate central 5 of the lower eyelid Meibomian gland openings in the midportion of the lower eyelid): Right Eye None plugged ( ) 0 Mild (1-2 glands plugged) ( ) 1 Moderate (3-4 glands plugged) ( ) 2 Severe (All 5 plugged) ( ) Lid Secretion from Meibomian Gland (Right Eye): (USE THE MGE- with mild pressure/depress shaft about half way) Right Eye Clear ( ) 0 Mild haze/cloudiness ( ) 1 Paste (like toothpaste) ( ) 2 Obstructed (no secretions) ( ) 3

23 FOLLOW-UP OCULAR EVALUATION FORM OA (016.2) 05/26/15 Page 7 of 12 LISSAMINE GREEN STAINING OF THE INTERPALPEBRAL CONJUNCTIVA RIGHT EYE INSTRUCTIONS 1. WITHOUT flushing the eye to remove fluorescein, instill 5 µl of 1% lissamine green into the lower conjunctival sac of the right eye. 2. Grade the lissamine green staining after 1-2 minutes have elapsed following instillation. Using white light of low intensity, grade the bulbar region of the nasal and temporal conjunctiva for staining. 3. Score each section from Grade 0-3 (maximum 6 per eye). Time of drop instillation Right Eye: : AM/PM Hr Mins circle one Wait 1-2 minutes after instillation before grading. 20. Lissamine green staining Grade (0-3/per each section) 20a. Temporal 20b. Nasal T Right Eye N 0= No coloration 1= Some punctations 2= Well defined punctations 3= Many punctations

24 FOLLOW-UP OCULAR EVALUATION FORM OA (016.2) 05/26/15 Page 8 of 12 TEAR BREAK UP TIME LEFT EYE Instructions Instill 5 µl of fluorescein 2% in the left eye. Allow patient to blink a few times. Wait 30 seconds after instillation. Measure the TBUT 3 times using a digital stopwatch within 1 minute of instillation. If the TBUT is >20 seconds, just record 20.0 seconds. 21. Time of drop instillation Left Eye: : AM/PM Hr Min circle one Wait 30 seconds after instillation before recording TBUT. 22. Record TBUT time Left Eye (USE STOPWATCH): 22a. 1st measure:. secs 22b. 2nd measure:. secs 22c. 3rd measure:. secs WAIT 2 MINUTES BEFORE PERFORMING CORNEAL STAINING EVALUATION OF THE LEFT EYE

25 FOLLOW-UP OCULAR EVALUATION FORM OA (016.2) 05/26/15 Page 9 of 12 CORNEAL STAINING FLUORESCEIN LEFT EYE Instructions Corneal staining must be performed approximately 2.5 minutes after fluorescein instillation. Allow patient to blink a few times. Use a yellow barrier filter with a cobalt blue illumination. Score each section from Grade Fluorescein staining Grade (0-3) Left Eye Grade 23a. Top Top 0 23b. Center 1 23c. Nasal 23d. Bottom Nasal Center Temporal 2 23e. Temporal Bottom Filamentary Keratitis (Left Eye) No ( ) 0 Yes ( ) 1

26 FOLLOW-UP OCULAR EVALUATION FORM OA (016.2) 05/26/15 Page 10 of Other Corneal Abnormality (Left Eye) No ( ) 0 Yes ( ) 1 25A. Specify Abnormality Left Eye: a. Corneal infiltrates ( ) 1 b. Corneal abrasion ( ) 1 c. Corneal ulcer ( ) 1 d. Neovascularization ( ) 1 e. Other (Specify below) ( ) 1 ( ) Meibomian Gland Evaluation (LEFT EYE): Plugging USE THE MGE with mild pressure/depress shaft about half way (evaluate central 5 of the lower eyelid Meibomian gland openings in the midportion of the lower eyelid): Left Eye None plugged ( ) 0 Mild (1-2 glands plugged) ( ) 1 Moderate (3-4 glands plugged) ( ) 2 Severe (All 5 are plugged) ( ) Lid Secretion from Meibomian Gland (Left Eye): (USE THE MGE- with mild pressure/ depress shaft about half way) Left Eye Clear ( ) 0 Mild haze/cloudiness ( ) 1 Paste (like toothpaste) ( ) 2 Obstructed (no secretions) ( ) 3

27 FOLLOW-UP OCULAR EVALUATION FORM OA (016.2) 05/26/15 Page 11 of 12 LISSAMINE GREEN STAINING OF THE INTERPALPEBRAL CONJUNCTIVA LEFT EYE INSTRUCTIONS 1. WITHOUT flushing the eye to remove fluorescein, instill 5 µl of 1% lissamine green into the lower conjunctival sac of the left eye. 2. Grade the lissamine green staining after 1-2 minutes have elapsed following instillation. Using white light of low intensity, grade the bulbar region of the nasal and temporal conjunctiva for staining. 3. Score each section from Grade 0-3(maximum 6 per eye).. Time of drop instillation Left Eye: : AM/PM Hr Min circle one Wait 1-2 minutes after instillation before grading. 28. Lissamine green staining Grade (0-3/per each section) GRADE Left Eye 28a. Nasal 28b. Temporal N T 0= No coloration 1= Some punctations 2= Well defined punctations 3= Many punctations 29. Last name & certification number of clinician performing examination: a. Print Last Name: b. Certification #: Signature of Clinician Performing Ocular Examination:

28 FOLLOW-UP OCULAR EVALUATION FORM OA (016.2) 05/26/15 Page 12 of Instrument used to measure IOP ( ) 1 Tonopen ( ) 2 Applanation INTRAOCULAR PRESSURE Time of anesthetic instillation: : AM/PM Hr Min circle one 31. Intraocular Pressure a. OD: mm Hg b. OS: mm Hg 32. Last name & certification number of person performing IOP: a. Print Last Name: b. Certification #: Wait 5 min after instillation of anesthetic before doing Schirmer s Test. SCHIRMER S TEST Perform a Schirmer s Test WITH anesthesia (5 minutes after anesthesia) 33. Record the mm of wetting after 5 minutes: a. Right Eye: mm b. Left Eye: mm 34. Last name & certification number of person performing Schirmer s: a. Print Last Name: b. Certification #: 35. Date of Exam / / 201 Month Day Year

29 CONCOMITANT MEDICATION LOG CM (009.1) 03/21/14 Page 1 of ID. No.: - Alpha Code: Instructions: At baseline enter all prescription and over the counter medications the patient is taking when they enter the study. At follow-up visits, review medications with the patient and record changes. If the dose changed, close out the original entry and re-enter the medication with the new dose. If the patient stopped the medication, enter the stop date. If the patient is taking new medications, enter all the information. Drug Code Medication Name (Generic name preferred) Indication/Reason Eye Treated (if applicable) R L Dose per Administration (check box if unknown) Unit Freq. Route of Admin. Start Date MMDDYYYY Stop Date MMDDYYYY 1 / / / / 1 / / / / 1 / / / / 1 / / / / 1 / / / / 1 / / / / Unit Frequency Route of Administration 1 = tablespoon 10 = microcurie (mcc) 2 = teaspoon 11 = grain 3 = ounce 12 = units 4 = gram 88 = unknown unit 5 = milligram (mg) 98 = other 6 = microgram (mcg) 7 = milliliter (ml) 8 = microliter (mcl) 9 = millicure (mlc) 1 = 1X per day (qd) 2 = 2X per day (bid) 3 = 3X per day (tid) 4 = 4X per day (qid) 5= as needed (PRN) 88 = unknown 98 = other 1 = S.C. - subcutaneous 10 = nasal 2 = I.V. - intravenous 11 = sublingual 3 = eye drops 12 = intravitreal 4 = I.M. - intramuscular 13 = peribulbar 5 = P.O. - by mouth 14 = intra-articular 6 = P.R. - by rectum 15 = transdermal 7 = topical 16 = by ear 8 = vaginal 88 = unknown 9 = oral inhalation 98 = other Start and Stop Dates Enter best estimate of start/stop dates. If any part of the dates are unknown for the Month, Day or Year, enter 99 for each unknown value. Completed by: Certification #: Date Completed:

30 Adverse Event Log AE (006.1) 02/21/2014 Page of ID. No.: - Alpha Code: Instructions: Review all new or unresolved adverse events (currently on the Adverse Event Log in the DREAM clinical database) with the patient. If the Serious Event Type is greater than 1, complete a Serious Adverse Event Initial Reporting Form for the first report or a Serious Adverse Event Follow-up Form for new additional information. If this is an ocular adverse event involving one eye, please check the R or L boxes; if this is an ocular adverse event involving both eyes check both the R and L boxes. Adverse Event Coding (NIH) DREAM AE Coding AE # (Record from database) MedDRA Code MedDRA Short Name MedDRA Grade Was Event Serious? No Yes Serious Event Type Tx for AE No Yes Out- come DREAM Tx Ocular AE Eye(s) R L Start Date (MMDDYYYY) Stop Date (MMDDYYYY) Completed by: Certification #: Date Completed: DREAM AE Code Table Grade Serious Event Type Outcome DREAM Supplements (Tx) 1 = Mild 2 = Moderate 3 = Severe 4 = Life Threatening/disabling 5 = Death 1 = None 2 = Congenital Anomaly 3 = Hospitalization 4 = Disability 5 = Medically Significant 6 = Life Threatening 7 = Death 1 = Not Recovered 2 = Recovered 3 = Resolved with Sequelae 4 = Recovering/ Resolving 5 = Fatal 1 = Supplements continued 2 = Supplements temporarily stopped 3 = Supplements withdrawn