Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Completed NCT03284853 - Safety and Efficacy Study of PG324 (Netarsudil/Latanoprost 0.02% / 0.005%) Ophthalmic Solution Compared to GANFORT® Ophthalmic Solution in Open Angle Glaucoma or Ocular Hypertension Phase 3
Completed NCT01157364 - Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension Phase 1/Phase 2
Not yet recruiting NCT06441643 - Next Generation Rocklatan Phase 2
Recruiting NCT02471105 - Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml Phase 4
Recruiting NCT02792803 - A Comparison of Xalatan (Latanoprost) to Apo-latanoprost and Co-latanoprost in the Treatment of Glaucoma Phase 4
Terminated NCT02801617 - Non-inferiority of PRO-067 Ophthalmic Solution vs GAAP Ofteno® in Glaucoma or Ocular Hypertension Phase 3
Completed NCT02558374 - Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension Phase 3
Completed NCT02246764 - Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension Phase 3
Completed NCT02993445 - Effect of Alternate Therapies on Intraocular Pressure in Ocular Hypertension N/A
Completed NCT02628223 - 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma N/A
Completed NCT02338362 - Inhaled Corticosteroids: Effect on Intraocular Pressure in Patients With Controlled Glaucoma Phase 4
Completed NCT02390245 - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study N/A
Completed NCT01936389 - A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Exfoliation Syndrome and Ocular Hypertension or Glaucoma Phase 2
Completed NCT02003547 - A Single Centre Study to Evaluate 3 Ophthalmic Formulations in Healthy Subjects Phase 1
Completed NCT01995136 - Investigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution in Patients With Normal Tension Glaucoma Phase 4
Completed NCT01693315 - Multiple Dose-escalation Study of AMA0076 in Patients With Ocular Hypertension or Primary Open-angle Glaucoma Phase 2
Completed NCT01664039 - An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN® Phase 4
Active, not recruiting NCT01430923 - Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost N/A
Completed NCT01426867 - A Comfort Study of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2% Phase 2
Completed NCT01415401 - Efficacy and Tolerability of AZARGA® as Replacement Therapy in Patients on COMBIGAN® Therapy in Canada Phase 4