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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Glaucoma, Open-Angle, Ocular Hypertension

Intervention / Treatment
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* Combination Product: G2-TR intraocular implant containing travoprost
* Drug: Sham surgery + active-comparator eye drops


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implant Group 1<br>G2-TR intraocular implant containing travoprost 75 mcg with high elution rate, plus postoperative placebo eye drops. | Combination Product: G2-TR intraocular implant containing travoprost<br>* Provided in Arm/Group descriptions.<br>* Other names: Implant Group;|
| Experimental: Implant Group 2<br>G2-TR intraocular implant containing travoprost 75 mcg with low elution rate, plus postoperative placebo eye drops. | Combination Product: G2-TR intraocular implant containing travoprost<br>* Provided in Arm/Group descriptions.<br>* Other names: Implant Group;|
| Active Comparator: Control Group<br>Sham surgery + active-comparator eye drops | Drug: Sham surgery + active-comparator eye drops<br>* Sham surgery plus postoperative active-comparator eye drops (timolol maleate ophthalmic solution, 0.5%).<br>* Other names: Control Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Diurnal IOP (as Measured at 8AM and 10AM) Through 3 Months Postoperative | Change from time-matched baseline in IOP at 8AM and 10AM at Day 10, Week 6 and Month 3. Day 10 8AM IOP minus Baseline 8AM IOP; Day 10 10AM IOP minus Baseline 10AM IOP; Week 6 8AM IOP minus Baseline 8AM IOP; Week 6 10AM IOP minus Baseline 10AM IOP; Month 3 8AM IOP minus Baseline 8AM IOP; Month 3 10AM IOP minus Baseline 10AM IOP. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean IOP (Control Group vs. Each Implant Group) Through 12 Months Postoperative | Difference in mean IOP, between each test group and the control group, for IOP measurements through the Month 12 follow-up visit | 12 months |