A Single Dose Comfort Comparison of Travatan Z in One Eye Versus Xalatan in the Opposite Eye in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension

Phase 4

Completed

• Conditions: Open-Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®); Drug: Latanoprost ophthalmic solution 0.005% (XALATAN®)

• Registration Number: NCT00527592
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to compare the comfort of Travatan Z in one eye and Xalatan in the opposite eye in patients with primary open-angle glaucoma or ocular hypertension.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-09-10
• Study First Submitted QC: 2007-09-10
• Study First Posted: 2007-09-11
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Results First Submitted: 2009-11-13
• Results First Submitted QC: 2010-01-25
• Results First Posted: 2010-02-10
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-11
• Last Update Posted: 2012-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• 18 years of age or older.
• Clinical diagnosis of ocular hypertension, primary open-angle, pigment dispersion, or exfoliation glaucoma in both eyes.
• Best corrected visual acuity of 20/200 Snellen or better in each eye.
• Intraocular pressure within protocol-specified range.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

• Any abnormality preventing reliable applanation tonometry in the study eye(s).
• Any eye conditions or procedures as specified in protocol.
• Progressive retinal or optic nerve disease from any cause.
• Use of contact lenses in the study eye(s).
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Travoprost	Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)	Travoprost assigned to one eye, with latanoprost assigned to the fellow eye for intra-individual control. One drop, single dose. The eye, and the order in which the first test medicine was instilled (either travoprost or latanoprost), was randomly assigned.
Latanoprost	Latanoprost ophthalmic solution 0.005% (XALATAN®)	Latanoprost assigned to one eye, with travoprost assigned to the fellow eye for intra-individual control. One drop, single dose. The eye, and the order in which the first test medicine was instilled (either travoprost or latanoprost), was randomly assigned.

Primary Outcome Measures

Name	Time	Method
Comfort Immediately After Dosing	5 seconds	Comfort was assessed by the patient and recorded on a scale of 0 to 100, with 0 = perfect comfort and 100 = worse discomfort imaginable.