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

NCT00670033 | Completed Phase 2

• 1 other identifier: C-07-46
• Study Type: interventional
• Target: 158
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ocular Hypertension; Open-angle Glaucoma

Keywords

IOP; Open-angle glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in intraocular pressure (IOP)

  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.

  Baseline, Up to Week 4

Secondary Outcomes (2)

• Mean intraocular pressure

  Baseline, Up to Week 4

• Mean percent change from baseline in IOP

  Baseline, Up to Week 4

Study Arms (3)

Travoprost new formulation

EXPERIMENTAL

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)

TRAVATAN

ACTIVE COMPARATOR

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%

Vehicle

PLACEBO COMPARATOR

Inactive ingredients, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks

Drug: Vehicle

Interventions

Travoprost ophthalmic solution (new formulation) DRUG

Travoprost new formulation

Travoprost ophthalmic solution, 0.004% DRUG

Also known as: TRAVATAN®, TRAVATAN Z®

TRAVATAN

Vehicle DRUG

Inactive ingredients used as a placebo

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma, Open-Angle

Interventions

Travoprost

Condition Hierarchy (Ancestors)

Eye Diseases; Glaucoma

Intervention Hierarchy (Ancestors)

Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Theresa Landry, PhD

  Alcon Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2008
• First Posted: May 1, 2008
• Study Start: April 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: July 10, 2014

Record last verified: 2014-06