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

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: Completed
• Conditions: Eye Diseases; Dry Eye Syndromes
• Intervention / Treatment: Drug: OTX-DED; Drug: Controlled Insertion; Drug: Collagen Punctal Plug

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

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Ocular Therapeutix

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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))	Visual Analogue Scale (0 mm - no discomfort to 100mm - maximal (the most) discomfort)	Change from baseline (CFB) at Day 15

Collaborators and Investigators

• Sponsor: Ocular Therapeutix, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2023
• Primary Completion (Actual): May 22, 2024
• Study Completion (Actual): May 22, 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): July 10, 2024
• Last Update Submitted That Met QC Criteria: July 9, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• 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