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

Angle-closure Glaucoma Clinical Trial

Official title:

A Twelve-Week, Double Masked, Parallel Group, Primary-Therapy Pilot Study of the Safety and Efficacy of Travoprost 0.004% Compared to Pilocarpine 1% in Patients With Chronic Angle-Closure Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00762645
• Other study ID #: CM-06-04
• Status: Completed
• Phase: Phase 4
• Start date: February 2007
• Est. completion date: May 2008

Study information

• Verified date: March 2010
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angle-closure Glaucoma
• Glaucoma
• Glaucoma, Angle-Closure

Intervention

Drug:
• Travoprost 0.004% (Travatan)
One drop in each eye, once daily at 9 AM
• Pilocarpine 1%
One drop in each eye, forth times daily at 7 AM, 11 AM , 4 PM and 9 PM for twelve (12) weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Intraocular Pressure (IOP)		4PM at Week 12 Visit
Secondary	Number of Patients With Peripheral Anterior Synechiae (PAS)		Week 12 Visit