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

NCT ID: NCT00527592

Last Updated: 2012-05-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-08-31

Brief Summary

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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

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Conditions

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Open-Angle Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Travoprost

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.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop, single dose. Referred to as travoprost.

Latanoprost

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.

Group Type ACTIVE_COMPARATOR

Latanoprost ophthalmic solution 0.005% (XALATAN®)

Intervention Type DRUG

Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop, single dose. Referred to as latanoprost.

Interventions

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

Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop, single dose. Referred to as travoprost.

Intervention Type DRUG

Latanoprost ophthalmic solution 0.005% (XALATAN®)

Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop, single dose. Referred to as latanoprost.

Intervention Type DRUG

Other Intervention Names

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TRAVATAN Z® XALATAN®

Eligibility Criteria

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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.

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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SMA-07-01

Identifier Type: -

Identifier Source: org_study_id

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