NCT04360174

CLN-0045: Safety, and Efficacy of OTX-TIC in Participants With Open Angle Glaucoma or Ocular Hypertension

A Prospective, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of OTX-TIC (Travoprost) Implant in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Ocular Therapeutix, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety, tolerability and efficacy of a single sustained release dose of OTX-TIC, a sustained release travoprost drug product, in subjects with primary open-angle glaucoma or ocular hypertension.

Detailed description

This is a prospective, multicenter, open label study, to evaluate the safety, tolerability and efficacy of OTX-TIC intracameral implant in subjects with primary open-angle glaucoma or ocular hypertension. The subjects will be followed for approximately 7 months (one-month washout and 6 months follow-up after injected of the OTX-TIC implant).

Conditions

• Ocular Hypertension
• Open Angle Glaucoma

Interventions

Type	Name	Description
DRUG	OTX-TIC	OTX-TIC implant is injection in the anterior chamber of the eye

Timeline

• Start date: 2018-04-25
• Primary completion: 2021-05-24
• Completion: 2021-05-24
• First posted: 2020-04-24
• Last updated: 2024-10-01
• Results posted: 2024-10-01

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study