A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

Alcon

Status and phase: Completed; Phase 3

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (Cosopt); Drug: Travoprost 40 mcg/ml + Timolol 5 mg/ml eye drops, solution (DuoTrav); Other: Timolol Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT00333125

C-05-25

Details and patient eligibility

About

The purpose of this study is to compare the intraocular pressure (IOP)-lowering efficacy and safety of two combination products in patients with open-angle glaucoma or ocular hypertension.

Enrollment: 319 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 or older.
• Diagnosis of glaucoma or ocular hypertension.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Under 18.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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319 participants in 2 patient groups

Travoprost/Timolol

Experimental group

Treatment:

Drug: Travoprost 40 mcg/ml + Timolol 5 mg/ml eye drops, solution (DuoTrav)

Other: Timolol Vehicle

Dorzolamide/Timolol

Active Comparator group

Treatment:

Drug: Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (Cosopt)