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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

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ClinicalTrials.gov Identifier: NCT00527592
Recruitment Status : Completed
First Posted : September 11, 2007
Results First Posted : February 10, 2010
Last Update Posted : May 18, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Open-Angle Glaucoma Ocular Hypertension Drug: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®) Drug: Latanoprost ophthalmic solution 0.005% (XALATAN®) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : May 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008


Arm Intervention/treatment
Experimental: 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.
Drug: 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.
Other Name: TRAVATAN Z®
Active Comparator: 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.
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.
Other Name: XALATAN®



Primary Outcome Measures :
  1. Comfort Immediately After Dosing [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00527592     History of Changes
Other Study ID Numbers: SMA-07-01
First Posted: September 11, 2007    Key Record Dates
Results First Posted: February 10, 2010
Last Update Posted: May 18, 2012
Last Verified: May 2012

Keywords provided by Alcon Research:
Comfort

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Latanoprost
Travoprost
Antihypertensive Agents