Skip to main content
OpenTrials
Completed

NCT Number: NCT05814757

OTX-DED 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ocular Therapeutix

Memphis, Tennessee, 38119, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

OTX-DED

Drug

0.3mg dexamethasone ophthalmic insert

Controlled Insertion

Drug

Collagen Punctal Plug 0.2mm (Controlled Insertion)

Collagen Punctal Plug

Drug

Collagen Punctal Plug 0.2mm (Full Insertion)

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Ocular Therapeutix, Inc.

Industry

Registry information

Official study title

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)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 18, 2023
Registry last updated
Jul 10, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.