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

• Status: Not yet recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ocular Therapeutix, Inc.

Criteria

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.