OTX-DED for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED)
Phase 2
Completed
- Conditions
- Eye DiseasesDry Eye Syndromes
- Interventions
- Registration Number
- NCT05814757
- Lead Sponsor
- Ocular Therapeutix, Inc.
- Brief Summary
To assess the efficacy and safety of OTX-DED for the short-term treatment of the symptoms of DED
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Controlled Insertion utilizing Collagen Punctal Plug Controlled Insertion - OTX-DED 0.3mg OTX-DED - Collagen Punctal Plug (Full Insertion) Collagen Punctal Plug -
- Primary Outcome Measures
Name Time Method Severity of Eye Dryness Score (visual analogue scale (VAS)) Change from baseline (CFB) at Day 15 Visual Analogue Scale (0 mm - no discomfort to 100mm - maximal (the most) discomfort)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ocular Therapeutix
🇺🇸Memphis, Tennessee, United States