Travoprost 0.004% Versus Pilocarpine 1% in Patients With Chronic Angle Closure Glaucoma (CACG)

Alcon

Status and phase: Completed; Phase 4

Conditions: Angle-closure Glaucoma

Treatments: Drug: Pilocarpine 1%; Drug: Travoprost 0.004% (Travatan)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00762645

CM-06-04

Details and patient eligibility

About

The purpose of this study is to demonstrate that the Intraocular Pressure (IOP) lowering efficacy of Travoprost Ophthalmic Solution 0.004% is superior to that of Pilocarpine 1% in patients with chronic angle-closure glaucoma (CACG).

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Chronic Angle Closure Glaucoma (CACG)
• 21-35 millimeters mercury mean intraocular pressure on Eligibility visit day at 9 AM
• Peripheral iridotomy performed ≥ 1 Month prior to the Screening visit
• Anterior chamber angle in which the trabecular meshwork is not visible for ≥180 degrees in gonioscopy without indentation
• Peripheral anterior synechiae (PAS)

Exclusion criteria

• Traumatic damage of the anterior chamber angle
• History of ocular inflammation or surgery (except for iridotomy) ≤ 3 months
• Patients who cannot be safely discontinued from use of all ocular hypotensive medication(s) for 12 days to 14 weeks
• Visual Acuity ≥ 1.0
• Contact lenses wearer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Travoprost 0.004% (Travatan)

Experimental group

Description:

One drop in each eye, once daily at 9 AM

Treatment:

Drug: Travoprost 0.004% (Travatan)

Pilocarpine 1%

Active Comparator group

Description:

One drop in each eye, forth times daily at 7 AM, 11 AM , 4 PM and 9 PM for twelve (12) weeks

Treatment:

Drug: Pilocarpine 1%