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

Glaukos

Status and phase: Active, not recruiting; Phase 3

Conditions: Ocular Hypertension; Glaucoma, Open-Angle

Treatments: Combination Product: G2-TR intraocular implant containing travoprost; Drug: Sham surgery + active-comparator eye drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT03519386

GC-010

Details and patient eligibility

About

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).

Full description

This is a prospective, randomized, double-masked, active-controlled, parallel-group, multi-center trial comparing the efficacy and safety of the Model G2TR 063 Travoprost Intraocular Implant and the Model G2TR-125 Travoprost Intraocular Implant to topical timolol in subjects with OAG or OHT. The staff who record key efficacy measures and the study subjects will remain masked to study treatment.

Enrollment: 590 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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590 participants in 3 patient groups

Implant Group 1

Experimental group

Description:

G2-TR intraocular implant containing travoprost 75 mcg with high elution rate, plus postoperative placebo eye drops.

Treatment:

Combination Product: G2-TR intraocular implant containing travoprost

Implant Group 2

Experimental group

Description:

G2-TR intraocular implant containing travoprost 75 mcg with low elution rate, plus postoperative placebo eye drops.

Treatment:

Combination Product: G2-TR intraocular implant containing travoprost

Control Group

Active Comparator group

Description:

Sham surgery + active-comparator eye drops

Treatment:

Drug: Sham surgery + active-comparator eye drops