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OpenTrials
Completed

NCT Number: NCT04362670

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

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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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Ocular Therapeutix, Inc., Garden Grove, California, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OTX-CSI

Drug

OTX-CSI intracanalicular insert

Placebo Vehicle

Other

Hydrogel Vehicle intracanalicular insert

Primary outcomes

  1. Number of Subjects With At Least One (1) Treatment Emergent Adverse Event

    Time frame: From Screening to Study Exit, approximately 156 days.

    Number of Subjects With At Least One (1) Treatment Emergent Adverse Event

  2. Schirmer Test Score, CFB at Week 12

    Time frame: Change from Baseline at Week 12

    A Schirmer test strip measures the amount of tear production and provides a unit of measure in millimeters (mm).

Sponsors and collaborators

Lead sponsor

Ocular Therapeutix, Inc.

Industry

Registry information

Official study title

A Randomized, Multi-center, Double-masked, Vehicle-controlled, Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI (Cyclosporine Ophthalmic Insert) for Intracanalicular Use for the Treatment of Subjects With Dry Eye Disease (DED)

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 27, 2020
Registry last updated
Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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