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

Ocular Hypertension Clinical Trial

Official title:

Investigation of the Effect of Travoprost Ophthalmic Solution of Lowering Intraocular Pressure in Patients With Normal Tension Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01995136
• Other study ID #: M-13-047
• Secondary ID: UMIN000011621
• Status: Completed
• Phase: Phase 4
• First received: November 21, 2013
• Last updated: October 5, 2015
• Start date: September 2013
• Est. completion date: June 2014

Study information

• Verified date: October 2015
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Low Tension Glaucoma
• Normal Tension Glaucoma
• Ocular Hypertension

Intervention

Drug:
• Travoprost Ophthalmic Solution 0.004%
benzalkonium chloride (BAC) free

Locations

Country	Name	City	State
Japan	Alcon Japan, Ltd.	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in IOP (9:00 AM) at Week 4, Week 8, and 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.	Baseline (Day 0), Week 4, Week 8, Week 12	No