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NCT05814757 Clinical Trial

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

Dry Eye Syndromes Clinical Trial

Official 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05814757
Other study ID # OTX-DED-2022-C01
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date May 11, 2023
Est. completion date May 31, 2024

Study information
Verified date April 2024
Source Ocular Therapeutix, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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 information / eligibility
Status Active, not recruiting
Enrollment 100
Est. completion date May 31, 2024
Est. primary completion date April 11, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• OTX-DED
0.3mg dexamethasone ophthalmic insert
• Controlled Insertion
Collagen Punctal Plug 0.2mm (Controlled Insertion)
• Collagen Punctal Plug
Collagen Punctal Plug 0.2mm (Full Insertion)

Locations
Country Name City State
United States Ocular Therapeutix Memphis Tennessee

Sponsors (1)
Lead Sponsor Collaborator
Ocular Therapeutix, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Severity of Eye Dryness Score (visual analogue scale (VAS)) Visual Analogue Scale (0 mm - no discomfort to 100mm - maximal (the most) discomfort) Change from baseline (CFB) at Day 15
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