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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00670033
• Other study ID #: C-07-46
• Status: Completed
• Phase: Phase 2
• First received: April 29, 2008
• Last updated: July 9, 2014
• Start date: April 2008
• Est. completion date: September 2008

Study information

• Verified date: June 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-angle Glaucoma

Intervention

Drug:
• Travoprost ophthalmic solution (new formulation)

• Travoprost ophthalmic solution, 0.004%

• Vehicle
Inactive ingredients used as a placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Mean intraocular pressure	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).	Baseline, Up to Week 4	No
Secondary	Mean percent change from baseline in 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 percent change indicates a greater amount of improvement.	Baseline, Up to Week 4	No