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NCT02845674 Clinical Trial

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

Keratoconjunctivitis Sicca Clinical Trial

Official title:
An Open-Label Extension of 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 NCT02845674
Other study ID # OTX-101-2016-002
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date July 29, 2016
Est. completion date August 15, 2017

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

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 258
Est. completion date August 15, 2017
Est. primary completion date August 15, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Completion of Study OTX-101-2016-001 Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• OTX-101 0.09%
0.09% cyclosporine nanomicellar solution

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sun Pharmaceutical Industries Limited

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse Events Number of subjects reporting any AEs 40 weeks
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