NCT05814757

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Ocular Therapeutix, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Eye Syndromes
• Eye Diseases

Interventions

Type	Name	Description
DRUG	OTX-DED	0.3mg dexamethasone ophthalmic insert
DRUG	Controlled Insertion	Collagen Punctal Plug 0.2mm (Controlled Insertion)
DRUG	Collagen Punctal Plug	Collagen Punctal Plug 0.2mm (Full Insertion)

Timeline

• Start date: 2023-05-11
• Primary completion: 2024-05-22
• Completion: 2024-05-22
• First posted: 2023-04-18
• Last updated: 2024-07-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study