Investigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution in Patients With Normal Tension Glaucoma

Phase 4

Completed

• Conditions: Normal Tension Glaucoma; Ocular Hypertension
• Interventions: Drug: Travoprost Ophthalmic Solution 0.004%

• Registration Number: NCT01995136
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to investigate IOP reduction efficacy of travoprost 0.004% ophthalmic solution (TRAVATAN Z®) in subjects with normal tension glaucoma.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-11-21
• Study First Submitted QC: 2013-11-21
• Study First Posted: 2013-11-26
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Results First Submitted: 2015-06-25
• Results First Submitted QC: 2015-06-25
• Results First Posted: 2015-07-20
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-05
• Last Update Posted: 2015-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Diagnosis of normal tension glaucoma.
• Must sign an Informed Consent form.
• IOP within protocol-specified range.
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

• Pregnant and lactating women, or women who intend to become pregnant during the study period.
• Advanced and serious glaucoma, as specified in protocol.
• Complicated chronic or recurrent uveitis, scleritis or corneal herpes.
• History of ocular trauma, intraocular surgery or laser surgery for the included eye.
• Ocular-infection and severe ocular complication.
• Best-corrected visual acuity (BCVA) worse than 0.2 decimal.
• Difficulty in conducting applanation tonometry for the included eye as determined by the doctor.
• Severe or serious hypersensitivity to prostaglandin analogues or any ingredients used in the study.
• Use of IOP lowering ophthalmic solutions other than TRAVATAN Z® or oral carbonic anhydrase inhibitor (Diamox, etc.) during the study period.
• Use of any adrenocorticosteroids during the study period.
• Use of IOP lowering ophthalmic solution within the past 30 days.
• Regarded by doctor as not suitable for study participation.
• Other protocol-specified exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TRAVATAN Z	Travoprost Ophthalmic Solution 0.004%	Travoprost Ophthalmic Solution 0.004%, 1 drop instilled in each eye once daily at 9PM for 3 months.

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in IOP (9:00 AM) at Week 4, Week 8, and Week 12	Baseline (Day 0), Week 4, Week 8, Week 12	IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data at 9:00 AM from Weeks 4, 8, and 12 were pooled. A more negative change indicates a greater amount of improvement. One eye (study eye) was subject to analysis.

Trial Locations

Locations (1)

Alcon Japan, Ltd.; 🇯🇵 Tokyo, Japan