Overview

Dry Eye Assessment and Management: Feasibility Study

Status:
Completed
Trial end date:
2011-03-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to test a protocol investigating the efficacy of omega-3 fatty acids in treating dry eye disease. The study is termed "feasibility" because its purpose is to demonstrate an ability to execute the proposed protocol with compliance at two sites rather than generate statistically relevant data concerning the safety and efficacy of the supplement in patients with dry eye disease.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Asbell, Penny, M.D.
Collaborator:
National Eye Institute (NEI)
Criteria
Inclusion Criteria:

1. Sign and date the informed consent form approved by the IRB.

2. ≥ 18 years of age

3. Demonstrate at least 2 of the 4 following signs in the same eye at two consecutive
visits (Visit 1: 7 - 21 days prior to randomization, and Visit 2: day of
randomization).

1. Conjunctival staining present ≥ 1

2. Corneal fluorescein staining present ≥ 1

3. Tear film break up time (TFBUT) ≤ 7 seconds

4. Schirmer test ≤ 7 mm/5min

4. Demonstrate symptoms of dry eye disease (OSDI score of at least 22 at screening visit
and at least 15 at randomization visit).

5. Use or desire to use artificial tears on average of 2 times per day in the 2 weeks
preceding study entry (run in period). No newly diagnosed patients can be enrolled and
if a new patient wants to participate, she/he must be put on tears and re-evaluated in
6 months.

6. Intraocular pressure (IOP) ≥ 5 mmHg and ≤ 22 mmHg in each eye.

7. Women of child-bearing potential must agree to use a reliable method of contraception
during study participation, and must demonstrate a negative urine pregnancy test at
screening visit.

8. Be willing/able to return for all study visits and to follow instructions from the
study investigator and his/her staff.

9. Be able to swallow large, soft gelcaps

Exclusion Criteria:

1. Patients who are allergic to ingredients of the active or placebo pills (fish, olive
oil).

2. Current diagnosis of ocular infection (e.g. bacterial, viral or fungal).

3. History of ocular herpetic keratitis.

4. Eye surgery (including cataract surgery) within 6 months prior to randomization.

5. Previous LASIK surgery

6. Pregnant or nursing/lactating

7. Participation in a study of an investigational drug or device within the past 30 days.

8. Recent (≤ 3 months) initiation of use of systemic corticosteroids or other
immunosuppressive agent and/or is planning to change treatment during study
participation

9. Cognitive or psychiatric deficit that precludes informed consent or ability to perform
requirements of the investigation.

10. Contact lens wearers

11. Use of glaucoma medication or history of surgery for glaucoma.

12. Recent (≤ 3 months) insertion of punctual plugs.

13. Using punctual plugs but unwilling to commit to their use for the duration of the
study.

14. Unwilling to commit to same brand of artificial tears throughout the study.

15. Current use of EPA/DHA supplements in excess of 1 gram/day.

16. Recent (≤ 6 months) initiation of use of Restasis.

17. Use of Restasis but unwilling to commit to use of Restasis for the duration of the
study.

18. Discontinued use of Restasis within the last 3 months.