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

Sun Pharma

Status and phase: Completed; Phase 3

Conditions: Keratoconjunctivitis Sicca

Treatments: Drug: OTX-101 0.09%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02845674

OTX-101-2016-002

Details and patient eligibility

About

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

Enrollment: 258 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completion of Study OTX-101-2016-001

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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258 participants in 1 patient group

OTX-101 0.09%

Experimental group

Description:

0.09% cyclosporine nanomicellar solution

Treatment:

Drug: OTX-101 0.09%