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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01207752
Other study ID # SCCO 10-6
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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. -

Study Design


Related Conditions & MeSH terms


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
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