Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca

Keratoconjunctivitis Sicca Clinical Trial

— Emerald  

Official title:

A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02688556
• Other study ID #: OTX-101-2016-001
• Status: Completed
• Phase: Phase 3
• Start date: February 2016
• Est. completion date: December 2016

Study information

• Verified date: November 2021
• Source: Sun Pharmaceutical Industries Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca

Intervention

Drug:
• cyclosporine

• vehicle of OTX-101

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sun Pharmaceutical Industries Limited

Country where clinical trial is conducted

United States, 

Outcome

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