Travoprost New Formulations in Patients With Open-Angle Glaucoma or Ocular Hypertension

• ClinicalTrials.gov Identifier: NCT00670033
• Recruitment Status: Completed
• First Posted: May 1, 2008
• Last Update Posted: July 10, 2014
• Sponsor: Alcon Research
• Information provided by (Responsible Party): Alcon Research

Study Description

Brief Summary:

The purpose of this study was to describe the safety and IOP-lowering efficacy of Travoprost New Formulations compared to TRAVATAN® and to vehicle in patients with open-angle glaucoma or ocular hypertension.

Condition or disease	Intervention/treatment	Phase
Ocular Hypertension; Open-angle Glaucoma	Drug: Travoprost ophthalmic solution (new formulation); Drug: Travoprost ophthalmic solution, 0.004%; Drug: Vehicle	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 158 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Comparison of Safety and IOP-Lowering Efficacy of Three Alternative Travoprost Formulations to Vehicle and TRAVATAN® in Patients With Open-Angle Glaucoma or Ocular Hypertension
• Study Start Date: April 2008
• Actual Primary Completion Date: September 2008
• Actual Study Completion Date: September 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: Travoprost new formulation; Travoprost ophthalmic solution (new formulation), 1 of 3 dose levels, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks	Drug: Travoprost ophthalmic solution (new formulation)
Active Comparator: TRAVATAN; Travoprost ophthalmic solution 0.004%, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks	Drug: Travoprost ophthalmic solution, 0.004%; Other Names: TRAVATAN®; TRAVATAN Z®
Placebo Comparator: Vehicle; Inactive ingredients, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks	Drug: Vehicle; Inactive ingredients used as a placebo

Outcome Measures

Primary Outcome Measures :

1. Mean change from baseline in intraocular pressure (IOP) [ Time Frame: Baseline, Up to Week 4 ]
   IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement.

Secondary Outcome Measures :

1. Mean intraocular pressure [ Time Frame: Baseline, Up to Week 4 ]
   IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage).
2. Mean percent change from baseline in IOP [ Time Frame: Baseline, Up to Week 4 ]
   IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative percent change indicates a greater amount of improvement.

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:

• Satisfy all informed consent requirements;
• Diagnosed with open-angle glaucoma or ocular hypertension;
• Able to discontinue use of all IOP-lowering medications for a minimum of 5 to 28 days prior to the Eligibility 1 Visit;
• IOP measurements in at least 1 eye as specified in protocol;
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Females of childbearing potential if pregnant, breastfeeding, or not using highly effective birth control measures;
• Any form of glaucoma other than open-angle glaucoma;
• Severe central visual field loss in either eye;
• Chronic, recurrent or severe inflammatory eye disease;
• Clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment, in the opinion of the Investigator;
• Best-corrected visual acuity (BCVA) worse than 0.60 logarithm of the miniminum angle of resolution (logMAR);
• Intraocular surgery within the past 6 months;
• Ocular laser surgery within the past 3 months;
• Any abnormality preventing reliable applanation tonometry;
• Severe illness or any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study;
• Other protocol-specified exclusion criteria may apply.

Contacts and Locations

Sponsors and Collaborators

Alcon Research

Investigators

• Study Director: Theresa Landry, PhD; Alcon Research

More Information

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT00670033
• Other Study ID Numbers: C-07-46
• First Posted: May 1, 2008
• Last Update Posted: July 10, 2014
• Last Verified: June 2014

Keywords provided by Alcon Research:

IOP; Open-angle glaucoma; Ocular Hypertension

Additional relevant MeSH terms:

Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Travoprost; Pharmaceutical Solutions; Ophthalmic Solutions; Antihypertensive Agents