Divided Dose of TRAVATAN®

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01298687
• Other study ID #: C-10-081
• Status: Completed
• Phase: Phase 2
• First received: February 16, 2011
• Last updated: May 3, 2017
• Start date: February 2011
• Est. completion date: April 2011

Study information

• Verified date: July 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 exclusion criteria may apply.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Travoprost Ophthalmic Solution, 0.00013%
Cumulative daily dose is below the travoprost ophthalmic solution, 0.004% once daily dose
• Travoprost Ophthalmic Solution, 0.00033%
Cumulative daily dose equals the travoprost ophthalmic solution, 0.004% once daily dose
• Travoprost Ophthalmic Solution, 0.001%
Cumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose
• Travoprost Ophthalmic Solution, 0.00267%
Cumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose
• Travoprost Ophthalmic Solution, 0.004%

• Travoprost Vehicle
Inactive ingredients used as an active comparator

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour Area Under the Curve (AUC) in IOP Reduction		Day 5