Glaucoma, Primary Open AngleAPPEAL-TaiwanNCT01814761

A Study of Bimatoprost 0.01% in the Clinical Setting

An observational study of Glaucoma, Primary Open Angle and Ocular Hypertension, run by Allergan at 1 site in Taiwan.

Completed

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

Trial summary

This is a study of bimatoprost 0.01% (LUMIGAN® 0.01%) in subjects with primary open-angle glaucoma (POAG) or ocular hypertension (OH) who require further treatment for elevated intraocular pressure (IOP). Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Glaucoma, Primary Open Angle, Ocular Hypertension
What is being tested?: Bimatoprost 0.01%
How many people: 312 participants
Where: 1 siteTaiwan
Study dates: May 2013to Aug 2014
Phase: Observational
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

Study population: Subjects with primary open-angle glaucoma or ocular hypertension

Who may be able to join

Diagnosis of primary open-angle glaucoma or ocular hypertension
Determined by the treating physician to require treatment with bimatoprost 0.01%.

Who cannot join

Previous use of Lumigan® 0.01%

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Study site
Taichung

Other trials in Taiwan

About this study

Conditions: Glaucoma, Primary Open Angle, Ocular Hypertension
Being tested: Bimatoprost 0.01%
Medical subject headings: Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

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

Bimatoprost 0.01%Drug
Also called Lumigan® 0.01%
One drop of bimatoprost 0.01% (Lumigan® 0.01%) in the affected eye(s) every evening for 12 weeks.

Study groups in NCT01814761
Study group	Role	What they receive
Pts with POAG or OH (Previously Treatment Naive)		Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%). Receives: Drug: Bimatoprost 0.01%
Pts with POAG or OH (Switched Monotherapy)		Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%). Receives: Drug: Bimatoprost 0.01%

What is being measured

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

Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale
Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5-point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of patients in each severity grade are presented.
Measured: 12 Weeks

Secondary outcomes (3)

Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening).
Measured: Baseline, Week 12
Percentage of Patients Who Discontinue Due to an Adverse Event
An adverse event is any untoward medical occurrence associated with the use of a drug, whether or not considered drug related.
Measured: 12 Weeks
Overall Percent Change From Baseline in IOP
IOP is a measure of the fluid pressure inside the eye. A negative number change response indicates a reduction in IOP (improvement) and a positive number change response indicates an increase in IOP (worsening).
Measured: Baseline, Week 12

Timeline

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

May 2013Aug 2014

First posted20 Mar 2013 (estimated)
Study startMay 2013
Primary completionAug 2014
Study completionAug 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Glaucoma, Primary Open AngleStudies of the same condition, open and under way.
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: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 312 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01814761
Sponsor's protocol ID: GMA-AP-EYE-AGN-001
Acronym: APPEAL-Taiwan
Status last verified: Sep 2015
First submitted: 18 Mar 2013
Last updated: 26 Oct 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Chen YY, Wang TH, Liu C, Wu KY, Chiu SL, Simonyi S, Lu DW. Tolerability and efficacy of bimatoprost 0.01 % in patients with open-angle glaucoma or ocular hypertension evaluated in the Taiwanese clinical setting: the Asia Pacific Patterns from Early Access of Lumigan 0.01 % (APPEAL Taiwan) study. BMC Ophthalmol. 2016 Sep 15;16(1):162. doi: 10.1186/s12886-016-0338-6.
PubMed 27633513

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

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
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Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
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PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
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All Glaucoma, Primary Open Angle trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of Bimatoprost 0.01% in the Clinical Setting
ClinicalTrials.gov ID: NCT01814761
Acronym / sponsor ID: APPEAL-Taiwan / GMA-AP-EYE-AGN-001
Conditions: Glaucoma, Primary Open Angle, Ocular Hypertension
Study type: Observational
Recruitment status: Completed
Enrolment: 312 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: May 2013
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 20 Mar 2013 (estimated)
Results: Posted 26 Oct 2015

Clinical summary

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

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Pts with POAG or OH (Previously Treatment Naive)	–	Drug: Bimatoprost 0.01%Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
Pts with POAG or OH (Switched Monotherapy)	–	Drug: Bimatoprost 0.01%Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects with primary open-angle glaucoma or ocular hypertension

Key inclusion criteria (2 listed)

Diagnosis of primary open-angle glaucoma or ocular hypertension
Determined by the treating physician to require treatment with bimatoprost 0.01%.

Key exclusion criteria (1 listed)

Previous use of Lumigan® 0.01%

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
Bimatoprost 0.01%Also: Lumigan® 0.01%One drop of bimatoprost 0.01% (Lumigan® 0.01%) in the affected eye(s) every evening for 12 weeks.	Drug	Pts with POAG or OH (Previously Treatment Naive), Pts with POAG or OH (Switched Monotherapy)

Primary outcome

Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale
Time frame: 12 Weeks
Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5-point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of patients in each severity grade are presented.

3 secondary outcomes

Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
Time frame: Baseline, Week 12
Percentage of Patients Who Discontinue Due to an Adverse Event
Time frame: 12 Weeks
Overall Percent Change From Baseline in IOP
Time frame: Baseline, Week 12

Results and safety

Results posted to the registry on 26 Oct 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
Pts With POAG or OH (Previously Treatment Naive)	42	34
Pts With POAG or OH (Switched Monotherapy)	270	240

Primary outcome: Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale

Time frame: 12 Weeks. Number. Unit: Patients

Measure	Pts With POAG or OH (Previously Treatment Naive) n = 42	Pts With POAG or OH (Switched Monotherapy) n = 270
None	7	36
Trace	10	50
Mild	12	84
Moderate	5	59
Severe	0	11
Missing	8	30

Population analysed: Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pts With POAG or OH (Previously Treatment Naive)	1 of 42 (2.4%)	10 of 42 (23.8%)	Not reported
Pts With POAG or OH (Switched Monotherapy)	2 of 270 (0.7%)	16 of 270 (5.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27633513Chen YY, Wang TH, Liu C, Wu KY, Chiu SL, Simonyi S, Lu DW. Tolerability and efficacy of bimatoprost 0.01 % in patients with open-angle glaucoma or ocular hypertension evaluated in the Taiwanese clinical setting: the Asia Pacific Patterns from Early Access of Lumigan 0.01 % (APPEAL Taiwan) study. BMC Ophthalmol. 2016 Sep 15;16(1):162. doi: 10.1186/s12886-016-0338-6.

Related trials for Glaucoma, Primary Open Angle

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
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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.

Medical Director study director

Allergan

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

Questions about this trial

What is this clinical trial studying?

An observational study of Glaucoma, Primary Open Angle and Ocular Hypertension, run by Allergan at 1 site in Taiwan.

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 2 inclusion and 1 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 26 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 Taiwan. 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 26 Oct 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?

Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale (time frame: 12 Weeks). 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 NCT01814761, which also lists 1 linked publication.

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 26 Oct 2015.