Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI in Subjects With Dry Eye Disease.

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-23

Study Completion Date

2021-08-11

Brief Summary

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To assess the safety, tolerability and efficacy of a single dose of OTX-CSI, a sustained release cyclosporine drug product, in subjects with dry eye disease.

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Detailed Description

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Randomized, multi-center, double-masked, vehicle-controlled, Phase 1/2 study to evaluate the safety, tolerability, and efficacy of OTX-CSI in subjects with dry eye disease. The subjects will be followed for approximately 16 weeks after product insertion

Conditions

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Sequential: Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studies

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Cohort 2:

Formulation 3

Group Type PLACEBO_COMPARATOR

Placebo Vehicle

Intervention Type OTHER

Hydrogel Vehicle intracanalicular insert

Interventions

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OTX-CSI

OTX-CSI intracanalicular insert

Intervention Type DRUG

Placebo Vehicle

Hydrogel Vehicle intracanalicular insert

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Dry eye disease diagnosis
* VAS eye dryness severity score ≥ 30.

Exclusion Criteria

* Are unwilling to discontinue use of contact lenses
* Are unwilling to withhold use of artificial tears.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

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United States

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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CLN-Protocol-0054

Identifier Type: -

Identifier Source: org_study_id

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Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI in Subjects With Dry Eye Disease.

Study Results

Basic Information

Brief Summary

Related Clinical Trials

Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca

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

OTX-14-006: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Dry Eye

Study of Cyclosporine Ophthalmic Soution Group and Cyclosporine Ophthalmic Suspension Group

A Study Evaluating the Efficacy and Safety of RCI001 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye

Detailed Description

Conditions

Study Design

Study Groups

OTX-CSI-Cohort 1

OTX-CSI

OTX-CSI-Cohort 2

OTX-CSI

HV

Placebo Vehicle

OTX-CSI- Cohort 2

OTX-CSI

HV-2

Placebo Vehicle

Interventions

OTX-CSI

Placebo Vehicle

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Ocular Therapeutix, Inc.

Responsible Party

Locations

Ocular Therapeutix, Inc.

Ocular Therapeutix, Inc.

Ocular Therapeutix, Inc.

Ocular Therapeutix, Inc.

Ocular Therapeutix, Inc.

Ocular Therapeutix, Inc.

Ocular Therapeutix, Inc.

Ocular Therapeutix, Inc

Ocular Therapeutix

Ocular Therapeutix, Inc.

Ocular Therapeutix, Inc.

Ocular Therapeutix, Inc.

Ocular Therapeutix, Inc.

Ocular Therapeutix

Ocular Therapeutix, Inc.

Countries

Provided Documents

Document Type: Study Protocol

Document Type: Statistical Analysis Plan

Other Identifiers

CLN-Protocol-0054

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