Clinical trial

Prospective, Randomized Phase III Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5%

Name

GC-012

Description

Phase III study to compare the safety and efficacy of intraocular implants containing Travoprost at two different elution rates versus Timolol Maleate Ophthalmic Solution, 0.5% (Timolol) in reducing elevated intraocular pressure in subjects with open angle glaucoma (OAG) or ocular hypertension (OHT)

Trial arms

Trial start

2018-09-17

Estimated PCD

2022-06-10

Trial end

2024-06-01

Status

Active (not recruiting)

Phase

Early phase I

Treatment

G2-TR intraocular implant containing travoprost

Provided in Arm/Group descriptions

Arms:

Implant Group 1, Implant Group 2

Other names:

Implant Group

Sham surgery + active-comparator eye drops

Sham surgery plus postoperative active-comparator eye drops (Timolol Maleate ophthalmic solution, 0.5%)

Arms:

Control Group

Other names:

Control Group

Size

560

Primary endpoint

Change From Baseline in Diurnal IOP (as Measured at 8AM and 10AM) Through 3 Months Postoperative

3 Months

Eligibility criteria

Inclusion Criteria: * Diagnosed with open-angle glaucoma or ocular hypertension * C/D ratio ≤ 0.8 * Zero to two preoperative ocular hypotensive medications Exclusion Criteria: * Active corneal inflammation or edema * Retinal disorders not associated with glaucoma

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 560, 'type': 'ACTUAL'}}

Updated at

2023-09-26

1 organization

2 products

3 indications

Organization

Product

Indication

Indication

Indication

Product

Sham surgery + active-comparator eye drops