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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00527592
First received: September 10, 2007
Last updated: May 11, 2012
Last verified: May 2012

September 10, 2007
May 11, 2012
May 2007
August 2008   (final data collection date for primary outcome measure)
Comfort Immediately After Dosing [ Time Frame: 5 seconds ] [ Designated as safety issue: No ]
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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Complete list of historical versions of study NCT00527592 on ClinicalTrials.gov Archive Site
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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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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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Open-Angle Glaucoma
  • Ocular Hypertension
  • 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®
  • 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®
  • 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.
    Intervention: Drug: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (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.
    Intervention: Drug: Latanoprost ophthalmic solution 0.005% (XALATAN®)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
August 2008
August 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00527592
SMA-07-01
No
Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP