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

Last updated: July 9, 2024
Sponsor: Ocular Therapeutix, Inc.
Overall Status: Completed

Phase

2

Condition

Sjogren's Syndrome

Eyelid Inflammation

Dry Eyes

Treatment

OTX-DED

Controlled Insertion

Collagen Punctal Plug

Clinical Study ID

NCT05814757
OTX-DED-2022-C01
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • VAS eye dryness severity score ≥ 35 and ≤ 90 at screening.

  • Investigator assessment of bulbar conjunctival hyperemia grade ≥ 2 (CCLRU; 0 - 4scale).

  • 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

Exclusion Criteria:

  • Have worn contact lenses in the 4 weeks prior to the screening visit and/or areunwilling to discontinue use of contact lenses throughout the study period.

  • Have a history of glaucoma or ocular hypertension or have a history of intraocularpressure (IOP) < 5 mmHg or > 24 mmHg.

Study Design

Total Participants: 100
Treatment Group(s): 3
Primary Treatment: OTX-DED
Phase: 2
Study Start date:
May 11, 2023
Estimated Completion Date:
May 22, 2024

Study 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.

Connect with a study center

  • Ocular Therapeutix

    Memphis, Tennessee 38119
    United States

    Site Not Available

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