Dry Eye Assessment and Management: Feasibility Study

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Dry Eye Syndromes, Keratoconjunctivitis Sicca

In brief

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.

Key facts

Study ID

NCT01102257

Run by

Asbell, Penny, M.D.

People needed

23

Starts

2010-01-01

Expected to finish

2011-03-01

Last updated by the study team

2012-08-23

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Sign and date the informed consent form approved by the IRB.
• ≥ 18 years of age
• 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).
• Conjunctival staining present ≥ 1
• Corneal fluorescein staining present ≥ 1
• Tear film break up time (TFBUT) ≤ 7 seconds
• Schirmer test ≤ 7 mm/5min
• Demonstrate symptoms of dry eye disease (OSDI score of at least 22 at screening visit and at least 15 at randomization visit).
• 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.
• Intraocular pressure (IOP) ≥ 5 mmHg and ≤ 22 mmHg in each eye.
• 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.
• Be willing/able to return for all study visits and to follow instructions from the study investigator and his/her staff.
• Be able to swallow large, soft gelcaps

You may not qualify if…

• Patients who are allergic to ingredients of the active or placebo pills (fish, olive oil).
• Current diagnosis of ocular infection (e.g. bacterial, viral or fungal).
• History of ocular herpetic keratitis.
• Eye surgery (including cataract surgery) within 6 months prior to randomization.
• Previous LASIK surgery
• Pregnant or nursing/lactating
• Participation in a study of an investigational drug or device within the past 30 days.
• Recent (≤ 3 months) initiation of use of systemic corticosteroids or other immunosuppressive agent and/or is planning to change treatment during study participation
• Cognitive or psychiatric deficit that precludes informed consent or ability to perform requirements of the investigation.
• Contact lens wearers
• Use of glaucoma medication or history of surgery for glaucoma.
• Recent (≤ 3 months) insertion of punctual plugs.
• Using punctual plugs but unwilling to commit to their use for the duration of the study.
• Unwilling to commit to same brand of artificial tears throughout the study.
• Current use of EPA/DHA supplements in excess of 1 gram/day.
• Recent (≤ 6 months) initiation of use of Restasis.
• Use of Restasis but unwilling to commit to use of Restasis for the duration of the study.
• Discontinued use of Restasis within the last 3 months.

Where it is running

• Mount Sinai School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.