N/A
Completed N=69
The Efficacy of an Ocular Emulsion in Meibomian Gland Dysfunction
Source: ClinicalTrials.gov NCT01207752 ↗Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcomePrimary: Tear Film Breakup Time — 4.65; 4.42 seconds — p=0.550
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tear Film Breakup Time |
4.65; 4.42 | 0.550 |
Eligibility 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. -
Data sourced from ClinicalTrials.gov (NCT01207752). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.