Divided Dose of TRAVATAN®

Phase 2

Completed

• Conditions: Open-angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Travoprost Ophthalmic Solution, 0.004%; Drug: Travoprost Ophthalmic Solution, 0.00013%; Drug: Travoprost Ophthalmic Solution, 0.00033%; Drug: Travoprost Ophthalmic Solution, 0.001%; Drug: Travoprost Ophthalmic Solution, 0.00267%; Drug: Travoprost Vehicle

• Registration Number: NCT01298687
• Lead Sponsor: Alcon Research

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-16
• Study First Submitted QC: 2011-02-16
• Study First Posted: 2011-02-18
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2014-07
• Disposition First Submitted: 2014-07-28
• Disposition First Submitted QC: 2014-07-28
• Disposition First Posted: 2014-07-31
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TRAVATAN	Travoprost Ophthalmic Solution, 0.004%	Travoprost Ophthalmic Solution, 0.004%, 1 drop administered in each eye at 8 pm for 5 days, with 1 drop of vehicle administered at all other timepoints (2-hour intervals)
Trav 0.00013%	Travoprost Ophthalmic Solution, 0.00013%	Travoprost Ophthalmic Solution, 0.00013%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days
Trav 0.00033%	Travoprost Ophthalmic Solution, 0.00033%	Travoprost Ophthalmic Solution, 0.00033%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days
Trav 0.001%	Travoprost Ophthalmic Solution, 0.001%	Travoprost Ophthalmic Solution, 0.001%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days
Trav 0.00267%	Travoprost Ophthalmic Solution, 0.00267%	Travoprost Ophthalmic Solution, 0.00267%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days
Vehicle	Travoprost Vehicle	Travoprost vehicle, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days

Primary Outcome Measures

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