Three Month Safety and Efficacy Study of TRAVATAN® Versus Travoprost Ophthalmic Solution, 0.004%

Ocular Hypertension Clinical Trial

Official title:

Three Month Safety and Efficacy Study of TRAVATAN® vs Travoprost Ophthalmic Solution, 0.004%

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01452009
• Other study ID #: C-10-151
• Status: Withdrawn
• Phase: Phase 3
• First received: October 12, 2011
• Last updated: February 9, 2012
• Start date: November 2011
• Est. completion date: December 2011

Study information

• Verified date: February 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A multi-center, observer-masked, randomized, parallel group efficacy and safety study of TRAVATAN® versus a new formulation of Travoprost Ophthalmic Solution, 0.004%

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients 18 years of age or older

2. Either gender

3. Any race/ethnicity

4. Diagnosed with open-angle glaucoma (including patients with pseudoexfoliation and pigment dispersion) or ocular hypertension

Exclusion Criteria:

1. Patients with any form of glaucoma other than open-angle glaucoma.

2. Patients with a central cornea thickness greater than 620 µm

3. Patients with Shaffer angle Grade < 2

4. Patients with a cup/disc ratio greater than 0.80

5. Patients with severe central visual field loss

6. Best-Corrected Visual Acuity score worse than 55 ETDRS letters (20/80 Snellen equivalent)

7. Chronic, recurrent or severe inflammatory eye disease

8. Clinically significant or progressive retinal disease

9. Other ocular pathology

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Ocular Hypertension
• Open Angle Glaucoma

Intervention

Drug:
• Travoprost Ophthalmic Solution, 0.004% (New Formulation)
Travoprost Ophthalmic Solution, 0.004% given one drop once daily
• TRAVATAN®
TRAVATAN® administered one drop once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: mean IOP Efficacy as measured by mean IOP		3 months	No