GlaucomaNCT02246777

Alcon® Ex-PRESS® Glaucoma Filtration Device in Japanese Patients

A study testing Ex-PRESS® Glaucoma Filtration Device, Model P50PL in people with Glaucoma, 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

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Trial summary

The purpose of this study is to assess the efficacy and safety of the Alcon Ex-PRESS® Glaucoma Filtration Device (Ex-PRESS) in Japanese subjects with normal tension glaucoma. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Glaucoma
What is being tested?: Ex-PRESS® Glaucoma Filtration Device, Model P50PL
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteJapan
Study dates: 26 Feb 2014to 24 Oct 2016
Phase: Interventional
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.
Indicated for filtration surgery using Ex-PRESS®.
Understand and provide Informed Consent.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Women who are pregnant, lactating, or planning to be pregnant during the study period.
Diagnosis of angle closure glaucoma or secondary glaucoma.
History of glaucoma surgery.
Ophthalmologic surgery within the past 6 months.
Difficulty with applanation tonometry measurement.
Corneal dystrophy.

Show all 10Show fewer

Infectious/non-infectious conjunctivitis, keratitis, or uveitis in either eye.
Severe blepharitis or dry eye.
History of metal allergy.
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Contact Alcon Japan, Ltd for Trial Locations
Tokyo, 107-0052

Other trials in Japan

About this study

Official title: Assessment of Efficacy and Safety of the EX-PRESS® Glaucoma Filtration Device in Patients With Normal Tension Glaucoma

The purpose of this study is to assess the efficacy and safety of the Alcon Ex-PRESS® Glaucoma Filtration Device (Ex-PRESS) in Japanese subjects with normal tension glaucoma.

Conditions: Glaucoma
Being tested: Ex-PRESS® Glaucoma Filtration Device, Model P50PL
Keywords: Glaucoma
Medical subject headings: Glaucoma

What participants receive

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

Ex-PRESS® Glaucoma Filtration Device, Model P50PLDevice

Study groups in NCT02246777
Study group	Role	What they receive
Ex-PRESS	Experimental	Ex-PRESS® Glaucoma Filtration Device, Model P50PL, implanted in the anterior chamber of the study eye during glaucoma surgery intended for the lifetime of the patient Receives: Device: Ex-PRESS® Glaucoma Filtration Device, Model P50PL

What is being measured

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

Mean Intraocular Pressure (IOP)
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis.
Measured: Month 3, Month 6, Month 12 Post-Operative
Change From Baseline in IOP
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye contributed to the analysis.
Measured: Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative
Percent Change From Baseline in IOP
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye contributed to the analysis.
Measured: Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative
Percentage of Eyes With IOP Lowering Rate of 20% or More From Baseline up to Month 12
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis.
Measured: Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative
Percentage of Eyes Receiving Drug Therapy for Glaucoma Necessary to Maintain the IOP
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). For some subjects, both left and right eyes were targeted for the study, and data from both eyes were analyzed for this safety endpoint, as specified in the protocol.
Measured: Month 3, Month 6, Month 12 Post-Operative
Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Secondary surgical treatment included needling, laser suture lysis, and conjunctival and scleral flap sutures. For some subjects, both left and right eyes were targeted for the study, and data from both eyes were analyzed for this safety endpoint, as specified in the protocol. An eye may have received more than one procedure.
Measured: Month 3, Month 6, Month 12 Post-Operative

Timeline

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

26 Feb 201424 Oct 2016

First posted23 Sep 2014 (estimated)
Study start26 Feb 2014
Primary completion24 Oct 2016
Study completion24 Oct 2016

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 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 N/A
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: NCT02246777
Sponsor's protocol ID: ALJ-P2013-1
Other IDs: UMIN000013243
Status last verified: Jul 2018
First submitted: 18 Sep 2014
Last updated: 20 Jul 2018
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

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Efficacy and Safety of the EX-PRESS® Glaucoma Filtration Device in Patients With Normal Tension Glaucoma
ClinicalTrials.gov ID: NCT02246777
Acronym / sponsor ID: ALJ-P2013-1
Conditions: Glaucoma
Keywords: Glaucoma
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 26 Feb 2014 (actual)
Primary completion: 24 Oct 2016 (actual)
Study completion: 24 Oct 2016 (actual)
First posted: 23 Sep 2014 (estimated)
Results: Posted 20 Jul 2018

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 assess the efficacy and safety of the Alcon Ex-PRESS® Glaucoma Filtration Device (Ex-PRESS) in Japanese 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
Ex-PRESS	Experimental	Device: Ex-PRESS® Glaucoma Filtration Device, Model P50PLEx-PRESS® Glaucoma Filtration Device, Model P50PL, implanted in the anterior chamber of the study eye during glaucoma surgery intended for the lifetime of the patient

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.
Indicated for filtration surgery using Ex-PRESS®.
Understand and provide Informed Consent.
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (10 listed)

Women who are pregnant, lactating, or planning to be pregnant during the study period.
Diagnosis of angle closure glaucoma or secondary glaucoma.
History of glaucoma surgery.
Ophthalmologic surgery within the past 6 months.
Difficulty with applanation tonometry measurement.

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
Ex-PRESS® Glaucoma Filtration Device, Model P50PL	Device	Ex-PRESS

Primary outcome

Mean Intraocular Pressure (IOP)
Time frame: Month 3, Month 6, Month 12 Post-Operative
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis.
Change From Baseline in IOP
Time frame: Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye contributed to the analysis.
Percent Change From Baseline in IOP
Time frame: Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye contributed to the analysis.
Percentage of Eyes With IOP Lowering Rate of 20% or More From Baseline up to Month 12
Time frame: Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis.
Percentage of Eyes Receiving Drug Therapy for Glaucoma Necessary to Maintain the IOP
Time frame: Month 3, Month 6, Month 12 Post-Operative
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). For some subjects, both left and right eyes were targeted for the study, and data from both eyes were analyzed for this safety endpoint, as specified in the protocol.
Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP
Time frame: Month 3, Month 6, Month 12 Post-Operative
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Secondary surgical treatment included needling, laser suture lysis, and conjunctival and scleral flap sutures. For some subjects, both left and right eyes were targeted for the study, and data from both eyes were analyzed for this safety endpoint, as specified in the protocol. An eye may have received more than one procedure.

Results and safety

Results posted to the registry on 20 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ex-PRESS	32	29

Primary outcome: Mean Intraocular Pressure (IOP)

Time frame: Month 3, Month 6, Month 12 Post-Operative. Mean (Standard Deviation). Unit: mmHG

Measure	Ex-PRESS n = 29
Month 3	9.4 (4.3)
Month 6	9.5 (3.8)
Month 12	10.0 (3.1)

Population analysed: Intent-to-Treat, with non-missing data

Primary outcome: Change From Baseline in IOP

Time frame: Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative. Mean (Standard Deviation). Unit: mmHG

Measure	Ex-PRESS n = 29
Month 3	-5.4 (4.6)
Month 6	-5.4 (4.8)
Month 12	-4.9 (4.2)

Population analysed: Intent-to-Treat, with non-missing data

Primary outcome: Percent Change From Baseline in IOP

Time frame: Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative. Mean (Standard Deviation). Unit: percent change

Measure	Ex-PRESS n = 29
Month 3	-35.4 (30.1)
Month 6	-33.7 (33.5)
Month 12	-31.1 (23.6)

Population analysed: Intent-to-Treat, with non-missing data

Primary outcome: Percentage of Eyes With IOP Lowering Rate of 20% or More From Baseline up to Month 12

Time frame: Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative. Number. Unit: percentage of eyes

Measure	Ex-PRESS n = 29
Month 3	72.4
Month 6	82.1
Month 12	61.5

Population analysed: Intent-to-Treat, with non-missing data

Adverse events

Time frame: Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 15 months). This analysis population includes all subjects/eyes treated with the investigational device (32 subjects/37 eyes). Number at risk is reported in unit "eyes.". Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ex-PRESS	0 of 37 (0%)	13 of 37 (35.1%)	0 of 37

Limitations and caveats (from the sponsor): This study was a single-arm study with filtration surgery using EX-PRESS®. Although target sample size was 45 patients, only 32 patients (37 eyes) were enrolled due to a small number of patients meeting eligibility criteria of the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Alcon, A Novartis Division 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 study testing Ex-PRESS® Glaucoma Filtration Device, Model P50PL in people with Glaucoma, 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 10 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 20 Jul 2018. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jul 2018). 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 Intraocular Pressure (IOP) (time frame: Month 3, Month 6, Month 12 Post-Operative). The study lists 6 primary outcomes in all. 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 NCT02246777.

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 20 Jul 2018.