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



Status:Recruiting
Conditions:High Blood Pressure (Hypertension), Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:3/10/2019
Start Date:May 22, 2018
End Date:June 2023
Contact:Kerry Stephens, O.D.
Email:kstephens@glaukos.com
Phone:949-481-8057

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Trial Summary
Trial Overview
Inclusion Criteria

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

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).

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.

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.
We found this trial at
1
site
Vance Thompson Vision
Sioux Falls, South Dakota 57105
Phone: 605-361-3937
?
mi
from
Sioux Falls, SD
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