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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00527592
Other study ID # SMA-07-01
Secondary ID
Status Completed
Phase Phase 4
First received September 10, 2007
Last updated May 11, 2012
Start date May 2007
Est. completion date August 2008

Study information

Verified date May 2012
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date August 2008
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Alcon Research

Outcome

Type Measure Description Time frame Safety issue
Primary Comfort Immediately After Dosing Comfort was assessed by the patient and recorded on a scale of 0 to 100, with 0 = perfect comfort and 100 = worse discomfort imaginable. 5 seconds No
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