An Open-Label Extension of a Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca

Phase 3

Completed

• Conditions: Keratoconjunctivitis Sicca
• Interventions: Drug: OTX-101 0.09%

• Registration Number: NCT02845674
• Lead Sponsor: Sun Pharmaceutical Industries Limited

Brief Summary

This is a safety extension enrolling subjects participating in Study OTX-101-2016-001 (NCT02688556)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-24
• Study First Submitted QC: 2016-07-24
• Study First Posted: 2016-07-27
• Study Start: 2016-07-29
• Primary Completion: 2017-08-15
• Study Completion: 2017-08-15
• Results First Submitted: 2018-11-14
• Results First Submitted QC: 2018-12-12
• Results First Posted: 2018-12-14
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-18
• Last Update Posted: 2021-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

Inclusion Criteria

• Completion of Study OTX-101-2016-001

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OTX-101 0.09%	OTX-101 0.09%	0.09% cyclosporine nanomicellar solution

Primary Outcome Measures

Name	Time	Method
Adverse Events	40 weeks	Number of subjects reporting any AEs