The Efficacy of an Ocular Emulsion in Meibomian Gland Dysfunction

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study will be to determine the efficacy of this novel, lipid-containing artificial tear on the signs and symptoms of meibomian gland disease.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southern California College of Optometry; Southern California College of Optometry at Marshall B. Ketchum University
• Collaborator: Alcon Research
• Treatments: Lubricant Eye Drops; Ophthalmic Solutions; Tetrahydrozoline

Criteria

Inclusion Criteria:

• Schein symptom score (all 6 questions) of greater than 5,

• evidence of MGD changes in both eyes (i.e.,

• lower eyelid secretion quality score greater than 1.0 (0 - 3 scale) OR gland dropout score greater than 1.0 (i.e., greater than 25% of entire lower eyelid) as demonstrated by meiboscopy, and corneal staining of grade 4.0 or greater (0 - 20 scale).

Exclusion Criteria:

• contact lens wear, use of topical ocular medication other than artificial tears (use of Restasis is specifically excluded),

• unstable systemic medication use (i.e., anti-histamines, steroids, etc.), recent (within 6 months of study start) ocular trauma or surgery,

• diabetes, aqueous deficient dry eye (defined as a Schirmer I value (without anesthetic) of < 5 mm of wetting in 5 minutes in either eye), and use of punctal plugs.

-Subjects taking omega 3 fatty acid supplements for dry eye can be included so long as their intake is stable for the prior six months and they meet the inclusion criteria above. -