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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00670033

Enrollment

158

Registered

2008-05-01

Start date

2008-04-30

Completion date

2008-09-30

Last updated

2014-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Hypertension, Open-angle Glaucoma

Keywords

IOP, Open-angle glaucoma, Ocular Hypertension

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.

Interventions

DRUGTravoprost ophthalmic solution (new formulation)

DRUGTravoprost ophthalmic solution, 0.004%

DRUGVehicle

Inactive ingredients used as a placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Mean change from baseline in intraocular pressure (IOP)	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

Measure	Time frame	Description
Mean intraocular pressure	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).
Mean percent change from baseline in IOP	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026