A Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant for Patients With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)

Sponsor

Ocular Therapeutix, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05335122

Collaborator

(none)

105

Enrollment

Locations

Arms

15.5

Anticipated Duration (Months)

11.7

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To assess efficacy, and safety of a single sustained release dose of the OTX-TIC drug product (2 travoprost dose strengths) in subjects with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT)

Condition or Disease	Intervention/Treatment	Phase
Open Angle Glaucoma Ocular Hypertension	Drug: OTX-TIC low dose Travoprost Intracameral Implant Drug: OTX-TIC high dose Travoprost Intracameral Implant Drug: Durysta, Bimatoprost Intracameral Implant 10 µg	Phase 2

Detailed Description

This is a prospective, multi-center, randomized, parallel-group, controlled study to evaluate the efficacy, and safety of OTX-TIC (travoprost) intracameral implant in subjects with open angle glaucoma (OAG) or ocular hypertension (OHT). Approximately 105 subjects will be enrolled in this study at approximately 20 sites in the US. Subjects will be a randomized to one of three treatment groups OTX-TIC drug product (2 travoprost dose strengths) compared to a single injection of DurystaTM. Non study eyes will be treated with the PGA, if not contraindicated.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

105 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel: Participants are assigned to one of three groups in parallel for the duration of the studyParallel: Participants are assigned to one of three groups in parallel for the duration of the study

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Sponsor, Study Coordinator, Investigator

Primary Purpose:

Treatment

Official Title:

A Prospective, Multi-center, Randomized, Parallel-group, Controlled Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant in Subjects With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)

Actual Study Start Date :

Mar 16, 2022

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OTX-TIC Low Dose Travoprost Intracameral Implant low dose	Drug: OTX-TIC low dose Travoprost Intracameral Implant OTX-TIC implant is injected into the anterior chamber of the eye.
Experimental: OTX-TIC High Dose Travoprost Intracameral Implant high dose	Drug: OTX-TIC high dose Travoprost Intracameral Implant OTX-TIC implant is injected into the anterior chamber of the eye.
Active Comparator: Durysta Bimatoprost Intracameral Implant 10 µg	Drug: Durysta, Bimatoprost Intracameral Implant 10 µg Durysta is injected into the anterior chamber of the eye.

Arm

Intervention/Treatment

Experimental: OTX-TIC Low Dose

Travoprost Intracameral Implant low dose

Drug: OTX-TIC low dose Travoprost Intracameral Implant

OTX-TIC implant is injected into the anterior chamber of the eye.

Experimental: OTX-TIC High Dose

Travoprost Intracameral Implant high dose

Drug: OTX-TIC high dose Travoprost Intracameral Implant

OTX-TIC implant is injected into the anterior chamber of the eye.

Active Comparator: Durysta

Bimatoprost Intracameral Implant 10 µg

Drug: Durysta, Bimatoprost Intracameral Implant 10 µg

Durysta is injected into the anterior chamber of the eye.

Outcome Measures

Primary Outcome Measures

Efficacy outcome measures [Diurnal IOP [Time Frame: diurnal IOP at the 2 Week Visit] Diurnal IOP [Time Frame: diurnal IOP at the 6 Week Visit] Diurnal IOP [Time Frame: diurnal IOP at the 12 Week Visit]]
IOP changes from baseline at 8AM, 10AM, and 4PM at Week 2, Week 6, and Week 12 in the study eye

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Are 18 years of age or older at the time of screening
Provide written informed consent and are able to comply with all study requirements
Are willing to withhold glaucoma medications according to the study requirements, and in the opinion of the investigator can do so without significant risk
Have a negative pregnancy test result for women of childbearing potential at Baseline
Have a documented diagnosis of OHT, or OAG in the study eye

Exclusion Criteria:

Have an uncontrolled systemic disease or a debilitating disease (e.g., cardiovascular, hypertension, uncontrolled diabetes)
Are currently pregnant or breast-feeding or of childbearing potential without the use of adequate contraceptive methods during the length of the study
Non-responsive to topical prostaglandins, prostamides or prostaglandin analogs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ocular Therapeutiux, Inc.	Delray Beach	Florida	United States	33484
2	Ocular Therapeutix, Inc.	Roswell	Georgia	United States	30076
3	Ocular Therapeutix Inc	Carmel	Indiana	United States	46032
4	Ocular Therapeutix, Inc.	Saint Joseph	Missouri	United States	49085
5	Ocular Therapeutix Inc.	Saint Louis	Missouri	United States	63110
6	Ocular Therapeutiux, Inc.	Fargo	North Dakota	United States	58103
7	Ocular Therapeutix Inc	Oklahoma City	Oklahoma	United States	73112
8	Ocular Therapeutix, Inc.	Austin	Texas	United States	78701
9	Ocular Therapeutix, Inc.	Houston	Texas	United States	77030