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

Alcon

Status and phase: Completed; Phase 4

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Treatments: Drug: Latanoprost ophthalmic solution 0.005% (XALATAN®); Drug: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00527592

SMA-07-01

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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54 participants in 2 patient groups

Travoprost

Experimental group

Description:

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.

Treatment:

Drug: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)

Latanoprost

Active Comparator group

Description:

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.

Treatment:

Drug: Latanoprost ophthalmic solution 0.005% (XALATAN®)