Assessing Cosopt Switch Patients

Pharmaceutical Research Network

Status and phase: Completed; Phase 4

Conditions: Glaucoma, Pigmentary; Open-Angle Glaucoma; Exfoliation Syndrome; Ocular Hypertension

Treatments: Drug: dorzolamide/timolol maleate fixed combination; Drug: timolol maleate

Study type: Interventional

Funder types: Other

Identifiers

NCT00273442

PRN 05-007

Details and patient eligibility

About

To assess the safety and efficacy of a cohort of patients switched to the dorzolamide/timolol maleate fixed combination because they are insufficiently controlled on latanoprost monotherapy.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adults with clinical diagnosis of POAG, pigment-dispersion or exfoliation glaucoma or ocular hypertension
• the IOP on latanoprost must be 31 mm Hg or less in both eyes, and 21 to 31 mm Hg inclusive in at least one eye at 08:00 AM
• visual acuity should be 20/200 or better in each eye

Exclusion criteria

• contraindications to study drugs
• anticipated change in systemic hypotensive therapy during the trial
• use of any corticosteroids by any route in the three months immediately prior to Visit 2

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)