Back to resultsInvestigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution in Patients With Normal Tension Glaucoma
Primary Purpose
Normal Tension Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Travoprost Ophthalmic Solution 0.004%
Sponsored by
About this trial
This is an interventional treatment trial for Normal Tension Glaucoma focused on measuring Glaucoma, Ocular hypertension
Eligibility Criteria
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.
Sites / Locations
- Alcon Japan, Ltd.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TRAVATAN Z
Arm Description
Travoprost Ophthalmic Solution 0.004%, 1 drop instilled in each eye once daily at 9PM for 3 months.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01995136
Brief Title
Investigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution in Patients With Normal Tension Glaucoma
Official Title
Investigation of the Effect of Travoprost Ophthalmic Solution of Lowering Intraocular Pressure in Patients With Normal Tension Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Normal Tension Glaucoma, Ocular Hypertension
Keywords
Glaucoma, Ocular hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TRAVATAN Z
Arm Type
Experimental
Arm Description
Travoprost Ophthalmic Solution 0.004%, 1 drop instilled in each eye once daily at 9PM for 3 months.
Intervention Type
Drug
Intervention Name(s)
Travoprost Ophthalmic Solution 0.004%
Other Intervention Name(s)
TRAVATAN Z®
Intervention Description
benzalkonium chloride (BAC) free
Primary Outcome Measure Information:
Title
Mean Change From Baseline in IOP (9:00 AM) at Week 4, Week 8, and Week 12
Description
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.
Time Frame
Baseline (Day 0), Week 4, Week 8, Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danyel Carr, MS
Organizational Affiliation
Alcon Japan, Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Japan, Ltd.
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Investigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution in Patients With Normal Tension Glaucoma
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