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

Ocular Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04360174
• Other study ID #: CLN-Protocol-0045
• Status: Completed
• Phase: Phase 1
• Start date: April 25, 2018
• Est. completion date: May 24, 2021

Study information

• Verified date: February 2023
• Source: Ocular Therapeutix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 24, 2021
• Est. primary completion date: May 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have a documented diagnosis of ocular hypertension or primary open-angle glaucoma
• Have IOP that is currently controlled as assessed by the Investigator
• Have open, normal appearing anterior chamber angles as determined by gonioscopy

Exclusion Criteria:

• Have closed angle glaucoma, narrow angle glaucoma, pseudoexfoliation syndrome, pseudoexfoliation glaucoma, pigment dispersion or pigmentary glaucoma, glaucoma diagnosis prior to 15 years of age, inflammatory, neovascular or other secondary
• Have a known or suspected allergy and/or hypersensitivity to a prostaglandin (i.e. travoprost), fluorescein or to any component of the study products

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open Angle Glaucoma

Intervention

Drug:
• OTX-TIC
OTX-TIC implant is injection in the anterior chamber of the eye

Locations

Country	Name	City	State
United States	Ocular Therapeutix, Inc.	Austin	Texas
United States	Ocular Therapeutix, Inc.	Petaluma	California
United States	Ocular Therapeutix, Inc.	Racine	Wisconsin
United States	Ocular Therapeutix, Inc	Roswell	Georgia
United States	Ocular Therapeutix, Inc.	Torrance	California

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	Incidence of treatment emergent adverse events for each subject	All adverse events will be captured throughout the study	Through study completion, 6 months
Primary	Efficacy outcome	IOP measurements at 8 am, 10 am, and 4 pm	Diurnal IOP [Time Frame: 2 Week Visit]
Primary	Efficacy outcome	IOP measurements at 8 am, 10 am, and 4 pm	Diurnal IOP [ 6 Week Visit]
Primary	Efficacy outcome	IOP measurements at 8 am, 10 am, and 4 pm	Diurnal IOP [12 Week Visit]
Primary	Efficacy outcome	IOP measurements at 8 am, 10 am, and 4 pm	Diurnal IOP [4 Months Visit]
Primary	Efficacy outcome	IOP measurements at 8 am, 10 am, and 4 pm	Diurnal IOP [6 Months Visit]