Glaucoma, Primary Open AnglePhase 4NCT01833741

A Study of LUMIGAN® RC in the Clinical Setting

A Phase 4 study testing Bimatoprost 0.01% in people with Glaucoma, Primary Open Angle and Ocular Hypertension, run by Allergan at 1 site in Canada.

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

This study will evaluate bimatoprost 0.01% (LUMIGAN® RC) in patients with elevated intraocular pressure (IOP) due to primary open angle glaucoma (POAG) or ocular hypertension (OHT) in a clinical setting. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glaucoma, Primary Open Angle, Ocular Hypertension
What is being tested?: Bimatoprost 0.01%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,137 participants
Where: 1 siteCanada
Study dates: Dec 2009to Mar 2011
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Elevated IOP due to either primary open-angle glaucoma or ocular hypertension
Determined by the treating physician to require treatment with LUMIGAN® RC

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

Canada1 site

Study site
Barrie, Ontario

Other trials in Canada

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® RC
Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.

Study groups in NCT01833741
Study group	Role	What they receive
Bimatoprost 0.01%	Experimental	Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks. Receives: Drug: Bimatoprost 0.01%

What is being measured

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

Percentage of Treatment-Naive Patients With Ocular Hyperemia
Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Naive patients did not use glaucoma medication prior to study entry.
Measured: Week 12
Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia
Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Previously treated patients used glaucoma medication prior to study entry and were switched from their previous therapy to study treatment.
Measured: Week 12
Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia
Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Previously treated patients used glaucoma medication prior to study entry and added study treatment as adjunctive therapy.
Measured: Week 12

Secondary outcomes (7)

Percent Change From Baseline in Intraocular Pressure (IOP) in the Study Eye of Treatment-Naive Patients
IOP is a measurement of the fluid pressure inside the eye. Naive patients did not use glaucoma medication prior to study entry. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).
Measured: Baseline, 12 Weeks
Percent Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients
IOP is a measurement of the fluid pressure inside the eye. Previously treated patients used glaucoma medication prior to study entry and were switched from their previous therapy to study treatment. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).
Measured: Baseline, 12 Weeks
Percent Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy
IOP is a measurement of the fluid pressure inside the eye. Previously treated patients used glaucoma medication prior to study entry and added study treatment as adjunctive therapy. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).
Measured: Baseline, 12 Weeks
Change From Baseline in IOP in the Study Eye of Treatment-Naive Patients
IOP is a measurement 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 (worsening).
Measured: Baseline, Week 6, Week 12
Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients
IOP is a measurement 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 (worsening).
Measured: Baseline, Week 6, Week 12
Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy
IOP is a measurement 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 (worsening).
Measured: Baseline, Week 6, Week 12
Percentage of Patients Discontinuing Due to Ocular Adverse Events
Ocular adverse events are defined as any untoward medical occurrence in a patient's eye(s) during study participation, regardless of relationship to treatment.
Measured: 12 Weeks

Timeline

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

Dec 2009Mar 2011

First posted17 Apr 2013 (estimated)
Study startDec 2009
Primary completionMar 2011
Study completionMar 2011

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 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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1,137 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01833741
Sponsor's protocol ID: CLEAR
Status last verified: Sep 2013
First submitted: 15 Apr 2013
Last updated: 26 Sep 2013
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

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
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
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Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
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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 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of LUMIGAN® RC in the Clinical Setting
ClinicalTrials.gov ID: NCT01833741
Acronym / sponsor ID: CLEAR
Conditions: Glaucoma, Primary Open Angle, Ocular Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,137 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Dec 2009
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 17 Apr 2013 (estimated)
Results: Posted 26 Sep 2013

Clinical summary

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

Study design

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

Arm	Type	Receives
Bimatoprost 0.01%	Experimental	Drug: Bimatoprost 0.01%Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Elevated IOP due to either primary open-angle glaucoma or ocular hypertension
Determined by the treating physician to require treatment with LUMIGAN® RC

Key exclusion criteria (1 listed)

None

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® RCBimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.	Drug	Bimatoprost 0.01%

Primary outcome

Percentage of Treatment-Naive Patients With Ocular Hyperemia
Time frame: Week 12
Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Naive patients did not use glaucoma medication prior to study entry.
Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia
Time frame: Week 12
Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Previously treated patients used glaucoma medication prior to study entry and were switched from their previous therapy to study treatment.
Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia
Time frame: Week 12
Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Previously treated patients used glaucoma medication prior to study entry and added study treatment as adjunctive therapy.

7 secondary outcomes

Percent Change From Baseline in Intraocular Pressure (IOP) in the Study Eye of Treatment-Naive Patients
Time frame: Baseline, 12 Weeks
Percent Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients
Time frame: Baseline, 12 Weeks
Percent Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy
Time frame: Baseline, 12 Weeks
Change From Baseline in IOP in the Study Eye of Treatment-Naive Patients
Time frame: Baseline, Week 6, Week 12
Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients
Time frame: Baseline, Week 6, Week 12
Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy
Time frame: Baseline, Week 6, Week 12
Percentage of Patients Discontinuing Due to Ocular Adverse Events
Time frame: 12 Weeks

Results and safety

Results posted to the registry on 26 Sep 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bimatoprost 0.01%	1,137	997

Primary outcome: Percentage of Treatment-Naive Patients With Ocular Hyperemia

Time frame: Week 12. Number. Unit: Percentage of Patients

Measure	Bimatoprost 0.01% n = 460
0 (none)	32.2
+0.5 (trace)	39.8
+1 (mild)	21.3
+2 (moderate)	5.9
+3 (severe)	0.9

Population analysed: All patients who were consented and completed the Baseline visit, and who had data for Week 12

Primary outcome: Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia

Time frame: Week 12. Number. Unit: Percentage of Patients

Measure	Bimatoprost 0.01% n = 400
0 (none)	35.5
+0.5 (trace)	41.0
+1 (mild)	17.3
+2 (moderate)	6.0
+3 (severe)	0.3

Population analysed: All patients who were consented and completed the Baseline visit, and who had data for Week 12

Primary outcome: Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia

Time frame: Week 12. Number. Unit: Percentage of Patients

Measure	Bimatoprost 0.01% n = 141
0 (none)	28.4
+0.5 (trace)	36.9
+1 (mild)	24.1
+2 (moderate)	9.2
+3 (severe)	1.4

Population analysed: All patients who were consented and completed the Baseline visit, and who had data for Week 12

7 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
Bimatoprost 0.01%	3 of 1,137 (0.3%)	0 of 1,137 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Glaucoma, Primary Open Angle

RecruitingPhase 2
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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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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?

A Phase 4 study testing Bimatoprost 0.01% in people with Glaucoma, Primary Open Angle and Ocular Hypertension, run by Allergan at 1 site in Canada.

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 Sep 2013. 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 Canada. 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 26 Sep 2013). 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?

Percentage of Treatment-Naive Patients With Ocular Hyperemia (time frame: Week 12). The study lists 3 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 NCT01833741.

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 Sep 2013.