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

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01995136
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arm: 1
• Duration (Months): 9
• Patients Per Site Per Month: 3.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Normal Tension Glaucoma; Ocular Hypertension	Drug: Travoprost Ophthalmic Solution 0.004%	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Investigation of the Effect of Travoprost Ophthalmic Solution of Lowering Intraocular Pressure in Patients With Normal Tension Glaucoma
• Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TRAVATAN Z Travoprost Ophthalmic Solution 0.004%, 1 drop instilled in each eye once daily at 9PM for 3 months.	Drug: Travoprost Ophthalmic Solution 0.004%; benzalkonium chloride (BAC) free; Other Names: TRAVATAN Z®

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Japan, Ltd.	Tokyo		Japan

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Danyel Carr, MS, Alcon Japan, Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01995136
• Other Study ID Numbers: M-13-047; UMIN000011621
• First Posted: Nov 26, 2013
• Last Update Posted: Oct 7, 2015
• Last Verified: Oct 1, 2015

• Keywords provided by Alcon Research: Glaucoma; Ocular hypertension
• Additional relevant MeSH terms: Glaucoma; Ocular Hypertension; Low Tension Glaucoma; Hypertension; Travoprost; Ophthalmic Solutions

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 5 study sites located in Japan.
Pre-assignment Detail	This reporting group includes all enrolled subjects (32).

Arm/Group Title	TRAVATAN Z
Arm/Group Description	Ophthalmic Solution, 1 drop instilled in each eye once daily at 9PM for 3 months.
Period Title: Overall Study
STARTED	32
COMPLETED	31
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	TRAVATAN Z
Arm/Group Description	Ophthalmic solution, 1 drop instilled in each eye once daily at 9PM for 3 months.
Overall Participants	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.6 (11.1)
Sex: Female, Male (Count of Participants)
Female	18 60%
Male	12 40%
Baseline IOP (mmHg) [Mean (Standard Deviation) ]
9:00 AM	16.55 (1.43)
1:00 PM	15.72 (1.82)
5:00 PM	15.73 (2.17)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

This analysis population includes all enrolled subjects minus any subjects with all missing data and/or critical protocol deviation/s.

Arm/Group Title	TRAVATAN Z
Arm/Group Description	Ophthalmic Solution, 1 drop instilled in each eye once daily at 9PM for 3 months.
Measure Participants	30
Baseline	16.55
Change from Baseline	-3.37

Adverse Events

Time Frame	Adverse events (AEs) were collected for the duration of the study (Sep 2013 - Jun 2014). This analysis population includes all subjects enrolled in the study, minus any subject whose safety evaluation data is all missed (1 subject).
Adverse Event Reporting Description	An AE was defined as any medically undesirable event that develops in a subject that received the study drug regardless of causal relationship with the study drug.
Arm/Group Title	TRAVATAN Z
Arm/Group Description	Ophthalmic Solution, 1 drop instilled in each eye once daily at 9PM for 3 months.
All Cause Mortality
	TRAVATAN Z
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	TRAVATAN Z
	Affected / at Risk (%)	# Events
Total	0/31 (0%)
Other (Not Including Serious) Adverse Events
	TRAVATAN Z
	Affected / at Risk (%)	# Events
Total	0/31 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.