Travatan Versus Timoptic in Treating Open-angle Glaucoma or Ocular Hypertension

Glaucoma Clinical Trial

Official title:

A Twelve-Week, Double Masked, Parallel Group, Study of Travoprost 0.004% Compared to Timolol 0.5% in Patients With Open-Angle Glaucoma or Ocular Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00763061
• Other study ID #: MS-06-02
• Status: Completed
• Phase: Phase 4
• First received: September 26, 2008
• Last updated: February 23, 2010
• Start date: May 2006
• Est. completion date: April 2008

Study information

• Verified date: February 2010
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial Summary

To evaluate the Intraocular Pressure (IOP) lowering efficacy and safety of Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.

Description:

To evaluate the IOP lowering efficacy and safety fo Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =18 years;

• IOP=16-30mmHg

• OH or OAG with visual filed abnormality:

1. =3 adjacent points in 24 degrees field on the same side of the horizontal meridian, that have p <5% on the prepapillary diameter plot, one of which must have p <1%,

2. Glaucoma Hemifield Test outside normal limits,

3. Corrected Pattern Standard Deviation with p <5%

Exclusion Criteria:

• Previous damage of anterior chamber angle;

• ocular inflammation or ocular surgery within the past 3 months; Best Corrected Visual Acuity (logMAR) <1.0;

• contact lens wearer;

• severe central field loss;

• uncontrolled cardiovascular, hepatic or renal disease;

• any medication within past 1 month.

Study Design

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Ocular Hypertension

Intervention

Drug:
• Travoprost 0.004% Ophthalmic Solution (Travatan)
Travoprost at 9 AM + Placebo & 9 PM
• Timolol 0.5% Ophthalmic Solution (Timoptic)
Timolol in each eye, twice daily at 9 AM & 9 PM

Locations

Country	Name	City	State
United States	Alcon Call Center	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Intraocular Pressure (IOP) at 9 AM	Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.	At Week 12 - At the 9 AM time point for the patient's worse eye.	Yes
Primary	Week 12 - Mean IOP At 4 PM	Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.	At the 4 PM time point for the patient's worse eye.	Yes
Secondary	Mean IOP Change From Baseline at 9 AM	Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.	Baseline to Week 12 - at 9 AM	Yes
Secondary	Mean IOP Change at 4 PM	Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.	Baseline to Week 12 - at 4 PM	Yes