Normal Tension GlaucomaPhase 4NCT01995136

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

A Phase 4 study testing Travoprost Ophthalmic Solution 0.004% in people with Normal Tension Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Normal Tension Glaucoma, Ocular Hypertension
What is being tested?: Travoprost Ophthalmic Solution 0.004%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteJapan
Study dates: Sep 2013to Jun 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Show all 13Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Alcon Japan, Ltd.
Tokyo

Other trials in Japan

About this study

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

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
Being tested: Travoprost Ophthalmic Solution 0.004%
Keywords: Glaucoma, Ocular hypertension
Medical subject headings: Low Tension Glaucoma, Ocular Hypertension, Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Travoprost Ophthalmic Solution 0.004%Drug
Also called TRAVATAN Z®
benzalkonium chloride (BAC) free

Study groups in NCT01995136
Study group	Role	What they receive
TRAVATAN Z	Experimental	Travoprost Ophthalmic Solution 0.004%, 1 drop instilled in each eye once daily at 9PM for 3 months. Receives: Drug: Travoprost Ophthalmic Solution 0.004%

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline (Day 0), Week 4, Week 8, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2013Jun 2014

First posted26 Nov 2013 (estimated)
Study startSep 2013
Primary completionJun 2014
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Normal Tension GlaucomaStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01995136
Sponsor's protocol ID: M-13-047
Other IDs: UMIN000011621
Status last verified: Oct 2015
First submitted: 21 Nov 2013
Last updated: 7 Oct 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationPhase 1/2
Topical Insulin for Glaucoma (TING2)
Open Angle Glaucoma, Primary Open Angle Glaucoma
RecruitingObservational study
Dresden Glaucoma and Treatment Study (DGTS)
Glaucoma, Glaucoma, Open-Angle
Active, not recruiting
Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population
Primary Open Angle Glaucoma, Ocular Hypertension
Recruiting
Transcorneal Electrical Stimulation for the Treatment of Visual Field Defects in Patients With Open-Angle Glaucoma
Glaucoma, Primary Open Angle Glaucoma
Not yet recruiting
DSLT in Normal Tension Glaucoma (NTG) Asian Eyes
Normal Tension Glaucoma (NTG), Glaucoma

All Normal Tension Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of the Effect of Travoprost Ophthalmic Solution of Lowering Intraocular Pressure in Patients With Normal Tension Glaucoma
ClinicalTrials.gov ID: NCT01995136
Acronym / sponsor ID: M-13-047
Conditions: Normal Tension Glaucoma, Ocular Hypertension
Keywords: Glaucoma, Ocular hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Sep 2013
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 26 Nov 2013 (estimated)
Results: Posted 20 Jul 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
TRAVATAN Z	Experimental	Drug: Travoprost Ophthalmic Solution 0.004%Travoprost Ophthalmic Solution 0.004%, 1 drop instilled in each eye once daily at 9PM for 3 months.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Travoprost Ophthalmic Solution 0.004%Also: TRAVATAN Z®benzalkonium chloride (BAC) free	Drug	TRAVATAN Z

Primary outcome

Mean Change From Baseline in IOP (9:00 AM) at Week 4, Week 8, and Week 12
Time frame: 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.

Results and safety

Results posted to the registry on 20 Jul 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TRAVATAN Z	32	31

Primary outcome: Mean Change From Baseline in IOP (9:00 AM) at Week 4, Week 8, and Week 12

Time frame: Baseline (Day 0), Week 4, Week 8, Week 12. Least squares mean (95% Confidence Interval). Unit: mmHg

Measure	TRAVATAN Z n = 30
Baseline	16.55 (15.88 to 17.22)
Change from Baseline	-3.37 (-3.90 to -2.85)

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

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).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TRAVATAN Z	0 of 31 (0%)	0 of 31 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Normal Tension Glaucoma

Enrolling by invitationPhase 1/2
Topical Insulin for Glaucoma (TING2)
Open Angle Glaucoma, Primary Open Angle Glaucoma
RecruitingObservational study
Dresden Glaucoma and Treatment Study (DGTS)
Glaucoma, Glaucoma, Open-Angle
Active, not recruiting
Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population
Primary Open Angle Glaucoma, Ocular Hypertension
Recruiting
Transcorneal Electrical Stimulation for the Treatment of Visual Field Defects in Patients With Open-Angle Glaucoma
Glaucoma, Primary Open Angle Glaucoma
Not yet recruiting
DSLT in Normal Tension Glaucoma (NTG) Asian Eyes
Normal Tension Glaucoma (NTG), Glaucoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Danyel Carr, MS study director

Alcon Japan, Ltd.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Travoprost Ophthalmic Solution 0.004% in people with Normal Tension Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in IOP (9:00 AM) at Week 4, Week 8, and Week 12 (time frame: Baseline (Day 0), Week 4, Week 8, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01995136.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2015.