Keratoconjunctivitis Sicca Clinical Trial
— EmeraldOfficial title:
A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
Verified date | November 2021 |
Source | Sun Pharmaceutical Industries Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomized, double-masked, vehicle-controlled study of the safety and efficacy of OTX-101 (0.09% cyclosporine nanomicellar solution) in the treatment of keratoconjunctivitis sicca to be conducted at approximately 50 sites.
Status | Completed |
Enrollment | 745 |
Est. completion date | December 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - History of dry eye syndrome (KCS) for a period of at least 6 months - Clinical diagnosis of bilateral KCS - Lissamine green conjunctival staining sum score of = 3 to = 9 out of a total possible score of 12 (scoring excludes superior zones 2 and 4) in the same eye at both the Screening and Baseline Visits. - Global symptom score (SANDE) = 40 mm at both the Screening and Baseline Visits - Corrected Snellen visual acuity (VA) of better than 20/200 in each eye. Exclusion Criteria: - Use of cyclosporine ophthalmic emulsion 0.05% (Restasis®) within 3 months prior to the Screening Visit. - Previous treatment failure (lack of efficacy) with cyclosporine ophthalmic emulsion 0.05% (Restasis). - Diagnosis of Sjögren's disease ? 5 years prior to the Screening Visit. - Clinical diagnosis or any history of seasonal and/or perennial allergic conjunctivitis. - Use of systemic or topical medications within 7 days prior to the Screening Visit or during the study period that are known to cause dry eye. - Use of any topical ophthalmic medications, prescription (including anti-glaucoma medications) or over the counter (including artificial tears), other than the assigned study medication during the study period. - Current active eye disease other than dry wyw syndrome (i.e., any disease for which topical or systemic ophthalmic medication is necessary). - History of herpes keratitis. - Corneal transplant - Corneal refractive surgery within 6 months prior to the Screening Visit or postoperative refractive surgery symptoms of dryness that have not resolved. - Cataract surgery within 3 months prior to the Screening Visit. |
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Eye Institute | Edgewood | Kentucky |
United States | Fifth Avenue Eye Associates | New York | New York |
United States | Martel Eye Medical Group | Rancho Cordova | California |
Lead Sponsor | Collaborator |
---|---|
Sun Pharmaceutical Industries Limited |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tear Production | Percentage of Eyes with Increase from Baseline of = 10 mm in Schirmer's Test Score | Baseline and 12 weeks | |
Secondary | Conjunctival Staining | change from baseline in total conjunctival staining score (lissamine green, modified National Eye Institute scale) at 12 weeks.
Conjunctival Lissamine Green Staining Grades ranged from 0 (No punctate stain in zone) to 3 (Densely concentrated micropunctate stain spots) |
Baseline and 12 weeks | |
Secondary | Central Corneal Staining | change from baseline in central corneal staining score (fluorescein, modified NEI/FDA scale) at 12 weeks.
The Expanded National Eye Institute (NEI)/Industry Workshop Scale for Corneal Staining Score was used to grade each of the 5 areas of the cornea on a 0 (No punctate stain in area) to 4 (Severe diffuse (coalescent) macropunctate stain of the area) scale. |
Baseline and 12 weeks | |
Secondary | Symptom Score | change from baseline in modified Symptom Assessment in Dry Eye (SANDE) score at 12 weeks.
A modified SANDE instrument was used to evaluate dry eye symptoms at each visit. Subjects were asked to indicate: frequency of dry and irritated eyes on a scale of 0 (rarely) to 100 (all the time); and severity of dry eyes on a scale of 0 (very mild) to 100 (severe) The global symptom score is the square root of the frequency score times the severity score and will be completed at each visit. (range 0 to 100) Negative change from baseline indicates improvement. |
Baseline and 12 weeks |
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