OTX-DED for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED)

April 2, 2024 updated by: Ocular Therapeutix, Inc.

A Randomized, Double-masked, Study to Evaluate the Efficacy and Safety of OTX-DED (Dexamethasone Intracanalicular Ophthalmic Insert) for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED)

To assess the efficacy and safety of OTX-DED for the short-term treatment of the symptoms of DED

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Randomized, double-masked, study to evaluate the efficacy and safety of OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of the symptoms of dry eye disease (DED). The subjects will be followed for approximately two months.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • VAS eye dryness severity score ≥ 35 and ≤ 90 at screening.
  • Investigator assessment of bulbar conjunctival hyperemia grade ≥ 2 (CCLRU; 0 - 4 scale).
  • Unanesthetized Schirmer of > 0 and ≤ 10 mm.
  • Must not have used Artificial Tears during the Screening period.
  • IOP in both eyes ≥ 5 mmHg and ≤21 mmHg.

Exclusion Criteria:

  • Have worn contact lenses in the 4 weeks prior to the screening visit and/or are unwilling to discontinue use of contact lenses throughout the study period.
  • Have a history of glaucoma or ocular hypertension or have a history of intraocular pressure (IOP) < 5 mmHg or > 24 mmHg.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OTX-DED 0.3mg
Drug: OTX-DED
0.3mg dexamethasone ophthalmic insert
Experimental: Controlled Insertion utilizing Collagen Punctal Plug
Drug: Controlled Insertion
Collagen Punctal Plug 0.2mm (Controlled Insertion)
Placebo Comparator: Collagen Punctal Plug (Full Insertion)
Drug: Collagen Punctal Plug
Collagen Punctal Plug 0.2mm (Full Insertion)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of Eye Dryness Score (visual analogue scale (VAS))
Time Frame: Change from baseline (CFB) at Day 15
Visual Analogue Scale (0 mm - no discomfort to 100mm - maximal (the most) discomfort)
Change from baseline (CFB) at Day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ocular Therapeutix, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2023

Primary Completion (Estimated)

April 11, 2024

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

March 24, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OTX-DED-2022-C01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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