Glaucoma, Open-AnglePhase 4LOTUSNCT02061683

A Study of Bimatoprost in the Treatment of Primary Open Angle Glaucoma and Ocular Hypertension

A Phase 4 study testing Bimatoprost 0.03% in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Allergan at 1 site in China.

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 is a study of bimatoprost as initial, replacement, or adjunctive intraocular pressure (IOP)-lowering therapy in patients with primary open angle glaucoma and ocular hypertension. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glaucoma, Open-Angle, Ocular Hypertension
What is being tested?: Bimatoprost 0.03%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 263 participants
Where: 1 siteChina
Study dates: 19 Apr 2010to 24 Jun 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

Diagnosis of open-angle glaucoma or ocular hypertension
No use of Lumigan® in the past 3 months

Who cannot join

Received laser therapy, glaucoma surgery, cataract surgery, or other ocular surgery within the past 3 months

Trial locations and contacts

1 site in 1 country.

China1 site

Study site
Shanghai

Other trials in China

About this study

This is a study of bimatoprost as initial, replacement, or adjunctive intraocular pressure (IOP)-lowering therapy in patients with primary open angle glaucoma and ocular hypertension.

Conditions: Glaucoma, Open-Angle, Ocular Hypertension
Being tested: Bimatoprost 0.03%
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 0.03%Drug
Also called LUMIGAN®
Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.

Study groups in NCT02061683
Study group	Role	What they receive
Bimatoprost 0.03%	Experimental	Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months. Receives: Drug: Bimatoprost 0.03%

What is being measured

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

Intraocular Pressure (IOP) in the Study Eye
IOP is a measure of the fluid pressure inside the study eye. Patients were categorized by pre-study therapies and the bimatoprost-containing study therapy into the following 5 groups: Group A (pre-study: treatment naïve; during study: bimatoprost monotherapy); Group B (pre-study: prostaglandin analog [PGA] monotherapy, excluding bimatoprost; during study: bimatoprost monotherapy); Group C (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost monotherapy); Group D (pre-study: combination therapy including PGA, without bimatoprost; during study: pre-study combination therapy with PGA switched to bimatoprost); and Group E (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost adjunctive to pre-study therapy).
Measured: Month 3

Secondary outcomes (1)

Percentage of Patients With an Adverse Event of Conjunctival Hyperemia
Conjunctival 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). An adverse event is any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
Measured: 3 Months

Timeline

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

19 Apr 201024 Jun 2011

First posted13 Feb 2014 (estimated)
Study start19 Apr 2010
Primary completion24 Jun 2011
Study completion24 Jun 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Glaucoma, 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: 263 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02061683
Sponsor's protocol ID: CN-BIM-0901
Acronym: LOTUS
Status last verified: Apr 2019
First submitted: 11 Feb 2014
Last updated: 18 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Wang K, Xu L, Yuan Z, Yao K, Zhao J, Xu L, Fang A, Zhang M, Wu L, Ji J, Hou J, Liu Q, Sun X. Intraocular pressure-lowering efficacy and safety of bimatoprost 0.03% therapy for primary open-angle glaucoma and ocular hypertension patients in China. BMC Ophthalmol. 2014 Feb 25;14:21. doi: 10.1186/1471-2415-14-21.
PubMed 24568617

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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All Glaucoma, Open-Angle trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of Bimatoprost in the Treatment of Primary Open Angle Glaucoma and Ocular Hypertension
ClinicalTrials.gov ID: NCT02061683
Acronym / sponsor ID: LOTUS / CN-BIM-0901
Conditions: Glaucoma, Open-Angle, Ocular Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 263 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 19 Apr 2010 (actual)
Primary completion: 24 Jun 2011 (actual)
Study completion: 24 Jun 2011 (actual)
First posted: 13 Feb 2014 (estimated)
Results: Posted 18 Jun 2014

Clinical summary

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

This is a study of bimatoprost as initial, replacement, or adjunctive intraocular pressure (IOP)-lowering therapy in patients with primary open angle glaucoma and ocular hypertension.

Study design

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

Arm	Type	Receives
Bimatoprost 0.03%	Experimental	Drug: Bimatoprost 0.03%Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.

Who may qualify

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

Key inclusion criteria (2 listed)

Diagnosis of open-angle glaucoma or ocular hypertension
No use of Lumigan® in the past 3 months

Key exclusion criteria (1 listed)

Received laser therapy, glaucoma surgery, cataract surgery, or other ocular surgery within the past 3 months

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 0.03%Also: LUMIGAN®Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.	Drug	Bimatoprost 0.03%

Primary outcome

Intraocular Pressure (IOP) in the Study Eye
Time frame: Month 3
IOP is a measure of the fluid pressure inside the study eye. Patients were categorized by pre-study therapies and the bimatoprost-containing study therapy into the following 5 groups: Group A (pre-study: treatment naïve; during study: bimatoprost monotherapy); Group B (pre-study: prostaglandin analog [PGA] monotherapy, excluding bimatoprost; during study: bimatoprost monotherapy); Group C (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost monotherapy); Group D (pre-study: combination therapy including PGA, without bimatoprost; during study: pre-study combination therapy with PGA switched to bimatoprost); and Group E (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost adjunctive to pre-study therapy).

1 secondary outcome

Percentage of Patients With an Adverse Event of Conjunctival Hyperemia
Time frame: 3 Months

Results and safety

Results posted to the registry on 18 Jun 2014, 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 0.03%	263	203

Primary outcome: Intraocular Pressure (IOP) in the Study Eye

Time frame: Month 3. Mean (Standard Deviation). Unit: Millimeters of Mercury (mmHg)

Measure	Bimatoprost 0.03% n = 240
Group A (N=89)	16.5 (3.4)
Group B (N=33)	16.7 (3.3)
Group C (N=67)	15.7 (2.6)
Group D (N=18)	16.1 (3.5)
Group E (N=33)	17.2 (4.4)

Population analysed: All enrolled patients with data available for analysis

1 secondary outcome is 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 0.03%	0 of 250 (0%)	229 of 250 (91.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24568617Wang K, Xu L, Yuan Z, Yao K, Zhao J, Xu L, Fang A, Zhang M, Wu L, Ji J, Hou J, Liu Q, Sun X. Intraocular pressure-lowering efficacy and safety of bimatoprost 0.03% therapy for primary open-angle glaucoma and ocular hypertension patients in China. BMC Ophthalmol. 2014 Feb 25;14:21. doi: 10.1186/1471-2415-14-21.

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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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RecruitingPhase 4
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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 0.03% in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Allergan at 1 site in China.

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 18 Apr 2019. 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 China. 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 18 Jun 2014). 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?

Intraocular Pressure (IOP) in the Study Eye (time frame: Month 3). 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 NCT02061683, 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 18 Apr 2019.