The Efficacy of an Ocular Emulsion in Meibomian Gland Dysfunction

Meibomian Gland Dysfunction Clinical Trial

Official title:

Evaluation of the Efficacy of an Ocular Emulsion on the Signs and Symptoms of Meibomian Gland Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01207752
• Other study ID #: SCCO 10-6
• Status: Completed
• Phase: N/A
• Start date: September 2010
• Est. completion date: July 2011

Study information

• Verified date: March 2021
• Source: Southern California College of Optometry at Marshall B. Ketchum University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. -

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction

Intervention

Drug:
• Systane Balance
Artificial tear emulsion drop
• Optive Lubricant Eye Drops
Artificial tear eye drop

Locations

Country	Name	City	State
United States	Eye Care Center	Fullerton	California

Sponsors (2)

Lead Sponsor	Collaborator
Southern California College of Optometry at Marshall B. Ketchum University	Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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