N/A N=69 Randomized Triple-blind Treatment

The Efficacy of an Ocular Emulsion in Meibomian Gland Dysfunction

Meibomian Gland Dysfunction

Bottom Line

View on ClinicalTrials.gov: NCT01207752 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2021

Primary outcome: Primary: Tear Film Breakup Time — 4.65; 4.42 seconds — p=0.550

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Systane Balance (Drug); Optive Lubricant Eye Drops (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Southern California College of Optometry at Marshall B. Ketchum University
Primary completion: Jul 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Tear Film Breakup Time	4.65; 4.42	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.

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. -

View full record on ClinicalTrials.gov →

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.