OTX-DED for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED)
Study Details
Study Description
Brief Summary
To assess the efficacy and safety of OTX-DED for the short-term treatment of the symptoms of DED
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
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 Design
Arms and Interventions
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)
|
Outcome Measures
Primary Outcome Measures
- Severity of Eye Dryness Score (visual analogue scale (VAS)) [Change from baseline (CFB) at Day 15]
Visual Analogue Scale (0mm - no pain to 100mm - worst pain)
Eligibility Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Ocular Therapeutix | Memphis | Tennessee | United States | 38119 |
Sponsors and Collaborators
- Ocular Therapeutix, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OTX-DED-2022-C01