Clinical trial
Prospective, Randomized Phase III Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5%
Name
GC-010
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
2018-07-26
Estimated PCD
2022-04-05
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
590
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 three 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': 590, 'type': 'ACTUAL'}}
Updated at
2023-09-14
1 organization
2 products
3 indications
Organization
GlaukosIndication
GlaucomaIndication
Open-AngleIndication
ocular hypertension