Divided Dose of TRAVATAN®

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01298687

Enrollment

Registered

2011-02-18

Start date

2011-02-28

Completion date

2011-04-30

Last updated

2017-05-05

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

Conditions

Open-angle Glaucoma, Ocular Hypertension

Keywords

open-angle glaucoma, ocular hypertension, divided dose

Brief summary

The purpose of this study is to compare the incremental dosing of travoprost ophthalmic solution versus once a day dosing of TRAVATAN® in lowering intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Interventions

DRUGTravoprost Ophthalmic Solution, 0.00013%

Cumulative daily dose is below the travoprost ophthalmic solution, 0.004% once daily dose

DRUGTravoprost Ophthalmic Solution, 0.00033%

Cumulative daily dose equals the travoprost ophthalmic solution, 0.004% once daily dose

DRUGTravoprost Ophthalmic Solution, 0.001%

Cumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose

DRUGTravoprost Ophthalmic Solution, 0.00267%

Cumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose

DRUGTravoprost Ophthalmic Solution, 0.004%

DRUGTravoprost Vehicle

Inactive ingredients used as an active comparator

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

* Patients with open-angle glaucoma or ocular hypertension who meet the following IOP criteria: 1. Mean IOP ≥ 24 mmHg in at least 1 eye, with the same eye qualifying at 8 AM at both Day 0 and Day 1; 2. Mean IOP ≤ 36 mmHg in both eyes at all time points on Day 0 and Day 1. * Must sign an informed consent form. * Other protocol-defined inclusion criteria may apply.

Exclusion criteria

* Females of childbearing potential who are pregnant, test positive on urine pregnancy test at the Screening Visit, intend to become pregnant during the study period, are breast-feeding, or are not using highly effective birth control measures. * Current or history of ocular inflammation or infection in either eye within the past 3 months. * Corneal thickness greater than 620 µm as determined by pachymetry in either eye. * Severe visual field loss. * Cup to disc ratio greater than 0.8 in either eye. * Intraocular surgery within the past 6 months in either eye. * Other protocol-defined

Design outcomes

Primary

Measure	Time frame
24-hour Area Under the Curve (AUC) in IOP Reduction	Day 5

Outcome results

None listed

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