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A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

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ClinicalTrials.gov Identifier: NCT00293800
Recruitment Status : Completed
First Posted : February 20, 2006
Last Update Posted : February 14, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of the study is to evaluate the safety and effectiveness of an investigational glaucoma therapy in patients with open-angle glaucoma or ocular hypertension.

Condition or disease Intervention/treatment Phase
Open-Angle Glaucoma Ocular Hypertension Drug: Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution Drug: Latanoprost 0.005% Ophthalmic Solution (XALATAN) Drug: Timolol 0.5% Ophthalmic Solution Other: Timolol Vehicle Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : July 2004
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Timolol

Arm Intervention/treatment
Experimental: Travoprost/Timolol
One drop Travoprost 0.004%/Timolol 0.5% in the study eye(s) each morning at 8 a.m. and one drop Timolol vehicle in the study eye(s) each evening at 8 p.m. for 3 months
Drug: Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution
Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension

Other: Timolol Vehicle
Placebo

Active Comparator: Xalatan + Timolol 0.5%
One drop Timolol 0.5% in the study eye(s) each morning at 8 a.m. and one drop Xalatan in the study eye(s) each evening at 8 p.m. for 3 months
Drug: Latanoprost 0.005% Ophthalmic Solution (XALATAN)
Commercially marketed ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension
Other Name: XALATAN

Drug: Timolol 0.5% Ophthalmic Solution
Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension




Primary Outcome Measures :
  1. Mean Intraocular Pressure (IOP) Change at 3 Months from Baseline [ Time Frame: 3 months ]


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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 or older.
  • Diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension.
  • Mean intraocular pressure (IOP) in at least one eye greater than 21 mmHg and less than or equal to 36 mmHg at screening visit.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Pregnant
  • History of chronic or recurrent severe inflammatory eye disease.
  • History of ocular infection or ocular inflammation within the past three months in either eye.
  • Other protocol-defined exclusion criteria may apply.

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00293800     History of Changes
Other Study ID Numbers: C-04-04
First Posted: February 20, 2006    Key Record Dates
Last Update Posted: February 14, 2012
Last Verified: February 2012

Keywords provided by Alcon Research:
Open-angle
glaucoma
ocular
hypertension

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