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

NCT01995136 | Completed Phase 4 Results

• 2 other identifiers: M-13-047UMIN000011621
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Normal Tension Glaucoma; Ocular Hypertension

Keywords

Glaucoma; Ocular hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

TRAVATAN Z

EXPERIMENTAL

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

Drug: Travoprost Ophthalmic Solution 0.004%

Interventions

Travoprost Ophthalmic Solution 0.004% DRUG

benzalkonium chloride (BAC) free

Also known as: TRAVATAN Z®

TRAVATAN Z

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of normal tension glaucoma.
• Must sign an Informed Consent form.
• IOP within protocol-specified range.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Alcon Japan, Ltd.

Tokyo, Japan

Location

MeSH Terms

Conditions

Low Tension Glaucoma; Ocular Hypertension; Glaucoma

Interventions

Travoprost

Condition Hierarchy (Ancestors)

Eye Diseases; Optic Nerve Diseases

Intervention Hierarchy (Ancestors)

Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Senior Manager, Phase IV
• Organization: Alcon Japan, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Danyel Carr, MS

  Alcon Japan, Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2013
• First Posted: November 26, 2013
• Study Start: September 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: October 7, 2015
• Results First Posted: July 20, 2015

Record last verified: 2015-10

Locations

JP (1)