The Efficacy of an Ocular Emulsion in Meibomian Gland Dysfunction
Evaluation of the Efficacy of an Ocular Emulsion on the Signs and Symptoms of Meibomian Gland Dysfunction
1 other identifier
interventional
69
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 21, 2010
CompletedFirst Posted
Study publicly available on registry
September 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedResults Posted
Study results publicly available
April 9, 2021
CompletedApril 1, 2025
March 1, 2025
10 months
September 21, 2010
January 26, 2016
March 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tear Film Breakup Time
time in seconds to observer a dark spot in the tear film
Measured 2 hours after in-office administration of a single drop of test solution
Study Arms (2)
Systane Balance
EXPERIMENTALArtificial tear emulsion
Optive Lubricant Eye Drops
ACTIVE COMPARATORArtificial tear
Interventions
Artificial tear eye drop
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eye Care Center
Fullerton, California, 92831, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jerry Paugh, OD, PhD
- Organization
- Southern California College of Optometry at MBKU
Study Officials
- PRINCIPAL INVESTIGATOR
Jerry R Paugh, OD, PhD
Southern California College of Optometry at Marshall B. Ketchum University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Emeritus
Study Record Dates
First Submitted
September 21, 2010
First Posted
September 23, 2010
Study Start
September 1, 2010
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
April 1, 2025
Results First Posted
April 9, 2021
Record last verified: 2025-03