Status:
COMPLETED
The Efficacy of an Ocular Emulsion in Meibomian Gland Dysfunction
Lead Sponsor:
Southern California College of Optometry at Marshall B. Ketchum University
Collaborating Sponsors:
Alcon Research
Conditions:
Meibomian Gland Dysfunction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed Description
This investigation will involve approximately 90 MGD subjects, randomly assigned to either the Systane Balance treatment group or a control group using Optive™ Lubricant Eyedrops (Allergan), a low-vis...
Eligibility Criteria
Inclusion
- 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
- 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. -
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT01207752
Start Date
September 1 2010
End Date
July 1 2011
Last Update
April 1 2025
Active Locations (1)
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1
Eye Care Center
Fullerton, California, United States, 92831