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

NCT02688556 | Completed Phase 3 Results

• 1 other identifier: OTX-101-2016-001
• Study Type: interventional
• Target: 745
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Keratoconjunctivitis Sicca

Keywords

KCS; dry eye; cyclosporine

Outcome Measures

Primary Outcomes (1)

• Tear Production

  Percentage of Eyes with Increase from Baseline of ≥ 10 mm in Schirmer's Test Score

  Baseline and 12 weeks

Secondary Outcomes (3)

• Conjunctival Staining

  Baseline and 12 weeks

• Central Corneal Staining

  Baseline and 12 weeks

• Symptom Score

  Baseline and 12 weeks

Study Arms (2)

OTX-101 0.09%

EXPERIMENTAL

0.09% cyclosporine nanomicellar ophthalmic solution

Drug: cyclosporine

Vehicle

PLACEBO COMPARATOR

vehicle of OTX-101

Drug: vehicle of OTX-101

Interventions

cyclosporine DRUG

Also known as: Seciera

OTX-101 0.09%

vehicle of OTX-101 DRUG

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Pharmaceutical Industries Limited: lead

Study Sites (3)

Martel Eye Medical Group

Rancho Cordova, California, 95670, United States

Location

Cincinnati Eye Institute

Edgewood, Kentucky, 41017, United States

Location

Fifth Avenue Eye Associates

New York, New York, 10028, United States

Location

MeSH Terms

Conditions

Keratoconjunctivitis Sicca; Dry Eye Syndromes

Interventions

Cyclosporine

Condition Hierarchy (Ancestors)

Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Keratitis; Corneal Diseases; Lacrimal Apparatus Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: SPARC
• Organization: Sun Pharma Advanced Research Company Limited

clinical.trials@sparcmail.com

+912266455645

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2016
• First Posted: February 23, 2016
• Study Start: February 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 29, 2022
• Results First Posted: April 8, 2019

Record last verified: 2021-11

Locations

US (3)