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

• ClinicalTrials.gov Identifier: NCT00763061
• Recruitment Status: Completed
• First Posted: September 30, 2008
• Results First Posted: January 26, 2010
• Last Update Posted: March 2, 2010
• Sponsor: Alcon Research
• Information provided by: Alcon Research

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Glaucoma	Drug: Travoprost 0.004% Ophthalmic Solution (Travatan); Drug: Timolol 0.5% Ophthalmic Solution (Timoptic)	Phase 4

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 111 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Study Start Date: May 2006
• Actual Primary Completion Date: April 2008
• Actual Study Completion Date: April 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: Travoprost 0.004%; Travoprost 0.004%	Drug: Travoprost 0.004% Ophthalmic Solution (Travatan); Travoprost at 9 AM + Placebo & 9 PM
Active Comparator: Timolol 0.5%; Timolol 0.5%	Drug: Timolol 0.5% Ophthalmic Solution (Timoptic); Timolol in each eye, twice daily at 9 AM & 9 PM

Outcome Measures

Primary Outcome Measures :

1. Mean Intraocular Pressure (IOP) at 9 AM [ Time Frame: At Week 12 - At the 9 AM time point for the patient's worse eye. ]
   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.
2. Week 12 - Mean IOP At 4 PM [ Time Frame: At the 4 PM time point for the patient's worse eye. ]
   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.

Secondary Outcome Measures :

1. Mean IOP Change From Baseline at 9 AM [ Time Frame: Baseline to Week 12 - 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.
2. Mean IOP Change at 4 PM [ Time Frame: Baseline to Week 12 - 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Texas

Alcon Call Center

Fort Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

More Information

• Responsible Party: Benny Li, Ph.D., Alcon Research Ltd
• ClinicalTrials.gov Identifier: NCT00763061
• Other Study ID Numbers: MS-06-02
• First Posted: September 30, 2008
• Results First Posted: January 26, 2010
• Last Update Posted: March 2, 2010
• Last Verified: February 2010

Keywords provided by Alcon Research:

Glaucoma

Additional relevant MeSH terms:

Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Timolol; Travoprost; Pharmaceutical Solutions; Ophthalmic Solutions; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Antihypertensive Agents