Phase 2/3 Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca

NCT02254265 | Completed Phase 2 Results

• 1 other identifier: OTX-101-2014-001
• Study Type: interventional
• Target: 455
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 2/3 study to evaluate the safety and efficacy of 2 different dose concentrations of OTX-101 dosed twice a day in both eyes for 84 days compared to placebo (vehicle) in patients with keratoconjunctivitis sicca (dry eye disease).

Conditions

Keratoconjunctivitis Sicca; Dry Eye Disease

Outcome Measures

Primary Outcomes (2)

• Conjunctival Staining

  Mean change from baseline at day 84 for the lissamine green conjunctival staining score in the designated study eye. The Investigator recorded a score for each area of each eye on a 0 (No punctate stain in zone) to 3 (Densely concentrated micropunctate stain spots) scale

  Baseline to 84 days

• Global Symptom Score

  Mean change from baseline at day 84 for the global symptom score. The freuency and severy of dry eye and irritation scores were used to calculate symptom score as follows: Frequency of dry eye/irritation based on a scale of 0 (rarely) to 100 (all the time) Severity of dryness or irritation based on a scale of 0 (very mildly) to 100 (very severe). The global symptom score was calculated as the square root of the frequency score times the severity score

  Baseline to 84 days

Secondary Outcomes (4)

• Tear Film Break up Time (TBUT)

  Baseline to 84 days

• Corneal Staining Score

  Baseline to 84 days

• Schirmer's Test

  Baseline to 84 days

• Patient Satisfaction

  Baseline to 84 days

Study Arms (3)

OTX-101 0.05%

EXPERIMENTAL

OTX-101 0.05% ophthalmic solution 1 drop in both eyes BID for 84 days

Drug: OTX-101 0.05%

OTX-101 0.09%

EXPERIMENTAL

OTX-101 0.09% ophthalmic solution 1 drop in both eyes BID for 84 days

Drug: OTX-101 0.09%

Vehicle

PLACEBO COMPARATOR

Vehicle of OTX-101 ophthalmic solution 1 drop in both eyes BID for 84 days

Drug: Vehicle

Interventions

OTX-101 0.05% DRUG

OTX-101 0.05% Ophthalmic Solution

OTX-101 0.05%

OTX-101 0.09% DRUG

OTX-101 0.09% Ophthalmic Solution

OTX-101 0.09%

Vehicle DRUG

Vehicle of OTX-101 Ophthalmic Solution

Vehicle

Eligibility Criteria

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

You may qualify if:

• Subjects age 18 years or older on the date of informed consent.
• All subjects must provide signed written consent prior to participation in any study-related procedures.
• Patient-reported history of KCS for a period of at least 6 months.
• Clinical diagnosis of bilateral KCS supported by OTX-101-2014-001 study assessments.
• 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 Screening and Baseline.
• Global symptom score ≥ 40 at both Screening and Baseline.
• Corrected Snellen VA of better than 20/200 in each eye.
• Willing to discontinue use of current dry eye therapy (including artificial tears or ocular lubricants) during the study as of the run-in period.
• Female subjects of childbearing potential must have a negative urine pregnancy test at Screening. Women of childbearing potential (ie, women who are not either postmenopausal for one year or surgically sterile) must use an acceptable form of contraception throughout the study.

You may not qualify if:

• Use of cyclosporine ophthalmic emulsion 0.05% (Restasis®) within 3 months prior to Screening.
• Previous treatment failure (lack of efficacy) on cyclosporine ophthalmic emulsion 0.05% (Restasis).
• Diagnosed with Sjögren's disease ˃5 years prior to Screening.
• Clinical diagnosis of seasonal and perennial allergic conjunctivitis.
• Use of systemic and topical medications that are known to cause dry eye within 7 days prior to Screening and throughout the study period. These include the following medications:
• Immunomodulators (permitted if dose is stable for 3 months prior to screening and does not change during the study period)
• Antihistamines (including over-the counter (OTC))
• Cholinergics
• Antimuscarinics
• Tricyclic antidepressants
• Phenothiazines
• Retinoids
• Oral omega-3 fatty acids (permitted if dose is stable for 3 months prior to Screening and does not change during the study period)
• Use of any topical ophthalmic medications, prescription (including antiglaucoma medications) or OTC (including artificial tears), other than the assigned study medication during the study period.
• Current active eye disease other than KCS (i.e., any disease for which topical or systemic ophthalmic medication is necessary).

Sponsors & Collaborators

• Sun Pharmaceutical Industries Limited: lead

Study Sites (1)

Unknown Facility

Cleveland, Ohio, United States

Location

MeSH Terms

Conditions

Keratoconjunctivitis Sicca; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

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

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 2
• 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: September 29, 2014
• First Posted: October 1, 2014
• Study Start: September 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: August 29, 2022
• Results First Posted: December 14, 2018

Record last verified: 2021-11

Locations

US (1)