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

NCT ID: NCT02845674

Last Updated: 2021-11-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-29

Study Completion Date

2017-08-15

Brief Summary

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

Detailed Description

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Conditions

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Keratoconjunctivitis Sicca

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OTX-101 0.09%

0.09% cyclosporine nanomicellar solution

Group Type EXPERIMENTAL

OTX-101 0.09%

Intervention Type DRUG

0.09% cyclosporine nanomicellar solution

Interventions

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OTX-101 0.09%

0.09% cyclosporine nanomicellar solution

Intervention Type DRUG

Other Intervention Names

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Seciera

Eligibility Criteria

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Inclusion Criteria

* Completion of Study OTX-101-2016-001

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Pharmaceutical Industries Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Sheppard J, Bergmann M, Schechter BA, Luchs J, Ogundele A, Karpecki P. Phase 3 Efficacy (Worse-Eye Analysis) and Long-Term Safety Evaluation of OTX-101 in Patients with Keratoconjunctivitis Sicca. Clin Ophthalmol. 2021 Jan 12;15:129-140. doi: 10.2147/OPTH.S279364. eCollection 2021.

Reference Type DERIVED
PMID: 33469259 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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OTX-101-2016-002

Identifier Type: -

Identifier Source: org_study_id