Open-angle GlaucomaNCT01068964

Safety and Efficacy of Bimatoprost Timolol Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension

A study testing 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution and 0.03% Bimatoprost Ophthalmic Solution and 0.5% Timolol Ophthalmic Solution in people with Open-angle Glaucoma 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 study will evaluate the safety and efficacy of once daily administered 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution compared with once daily administered 0.03% Bimatoprost Ophthalmic Solution and once daily administered 0.5% Timolol Ophthalmic Solution concurrently in patients with open-angle glaucoma or… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Open-angle Glaucoma, Ocular Hypertension
What is being tested?: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution and 0.03% Bimatoprost Ophthalmic Solution and 0.5% Timolol Ophthalmic Solution
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 235 participants
Where: 1 siteChina
Study dates: 1 Feb 2010to 1 Sep 2010
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 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of open-angle glaucoma or ocular hypertension in one or both eyes
Eye pressure lowering topical medications are not working
Visual acuity is at least 0.2 in each eye

Who cannot join

Uncontrolled systemic disease
Any other active eye disease other than glaucoma or ocular hypertension
Significant visual field loss or evidence of progressive visual field loss within the last year
Anticipated wearing of contact lenses during the study
Required chronic use of other ocular medications during the study
Eye surgery or laser treatment within 12 weeks prior to study enrollment

Trial locations and contacts

1 site in 1 country.

China1 site

Study site
Beijing

Other trials in China

About this study

Conditions: Open-angle Glaucoma, Ocular Hypertension
Being tested: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution, 0.03% Bimatoprost Ophthalmic Solution and 0.5% Timolol Ophthalmic Solution
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.

0.03% Bimatoprost/0.5% Timolol Ophthalmic SolutionDrug
Also called Bottle 1: Ganfort®
One drop from each bottle, administered once daily in the evening for 4 weeks Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution
0.03% Bimatoprost Ophthalmic Solution and 0.5% Timolol Ophthalmic SolutionDrug
Also called Bottle 1: Lumigan®, Bottle 2: Timoptol®
One drop from each bottle, administered once daily in the evening for 4 weeks Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution

Study groups in NCT01068964
Study group	Role	What they receive
0.03% Bimatoprost/0.5% Timolol in Same Bottle	Experimental	Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution Receives: Drug: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution
0.03% Bimatoprost and 0.5% Timolol in Separate Bottles	Active comparator	Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution Receives: Drug: 0.03% Bimatoprost Ophthalmic Solution and 0.5% Timolol Ophthalmic Solution

What is being measured

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

The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4
The difference of change from baseline of mean diurnal IOP between the 0.03% Bimatoprost/0.5% Timolol in Same Bottle and the 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles at week 4. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of the study eye (the eye with the highest IOP at baseline) over the 3 time points measured at 8AM, 12PM and 4PM. A negative number change from baseline indicated a reduction (improvement) in IOP. The difference of change from baseline in IOP is presented in the statistical analysis section.
Measured: Baseline, Week 4

Timeline

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

1 Feb 20101 Sep 2010

First posted17 Feb 2010 (estimated)
Study start1 Feb 2010
Primary completion1 Sep 2010
Study completion1 Sep 2010

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 Open-angle GlaucomaStudies 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 235 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01068964
Sponsor's protocol ID: 192024-052
Status last verified: Apr 2019
First submitted: 12 Feb 2010
Last updated: 17 Apr 2019
Results posted: Yes, on ClinicalTrials.gov

Publications

Ling Z, Zhang M, Hu Y, Yin Z, Xing Y, Fang A, Ye J, Chen X, Liu D, Wang Y, Sun W, Dong Y, Sun X. Safety and efficacy of bimatoprost/timolol fixed combination in Chinese patients with open-angle glaucoma or ocular hypertension. Chin Med J (Engl). 2014;127(5):905-10.
PubMed 24571886

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
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma

All Open-angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Bimatoprost Timolol Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension
ClinicalTrials.gov ID: NCT01068964
Acronym / sponsor ID: 192024-052
Conditions: Open-angle Glaucoma, Ocular Hypertension
Study type: Interventional
Recruitment status: Completed
Enrolment: 235 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 1 Feb 2010 (actual)
Primary completion: 1 Sep 2010 (actual)
Study completion: 1 Sep 2010 (actual)
First posted: 17 Feb 2010 (estimated)
Results: Posted 20 Jan 2012

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: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
0.03% Bimatoprost/0.5% Timolol in Same Bottle	Experimental	Drug: 0.03% Bimatoprost/0.5% Timolol Ophthalmic SolutionBottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution
0.03% Bimatoprost and 0.5% Timolol in Separate Bottles	Active comparator	Drug: 0.03% Bimatoprost Ophthalmic Solution and 0.5% Timolol Ophthalmic SolutionBottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Diagnosis of open-angle glaucoma or ocular hypertension in one or both eyes
Eye pressure lowering topical medications are not working
Visual acuity is at least 0.2 in each eye

Key exclusion criteria (6 listed)

Uncontrolled systemic disease
Any other active eye disease other than glaucoma or ocular hypertension
Significant visual field loss or evidence of progressive visual field loss within the last year
Anticipated wearing of contact lenses during the study
Required chronic use of other ocular medications during the study

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
0.03% Bimatoprost/0.5% Timolol Ophthalmic SolutionAlso: Bottle 1: Ganfort®One drop from each bottle, administered once daily in the evening for 4 weeks Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution	Drug	0.03% Bimatoprost/0.5% Timolol in Same Bottle
0.03% Bimatoprost Ophthalmic Solution and 0.5% Timolol Ophthalmic SolutionAlso: Bottle 1: Lumigan®, Bottle 2: Timoptol®One drop from each bottle, administered once daily in the evening for 4 weeks Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution	Drug	0.03% Bimatoprost and 0.5% Timolol in Separate Bottles

Primary outcome

The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4
Time frame: Baseline, Week 4
The difference of change from baseline of mean diurnal IOP between the 0.03% Bimatoprost/0.5% Timolol in Same Bottle and the 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles at week 4. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of the study eye (the eye with the highest IOP at baseline) over the 3 time points measured at 8AM, 12PM and 4PM. A negative number change from baseline indicated a reduction (improvement) in IOP. The difference of change from baseline in IOP is presented in the statistical analysis section.

Results and safety

Results posted to the registry on 20 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
0.03% Bimatoprost/0.5% Timolol in Same Bottle	121	113
0.03% Bimatoprost and 0.5% Timolol in Separate Bottles	114	104

Primary outcome: The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4

Time frame: Baseline, Week 4. Mean (Standard Deviation). Unit: Millimeters of mercury (mmHg)

Measure	0.03% Bimatoprost/0.5% Timolol in Same Bottle n = 120	0.03% Bimatoprost and 0.5% Timolol in Separate Bottles n = 114
Baseline	25.20 (3.06)	24.87 (3.88)
Change from Baseline at Week 4	-9.38 (4.66)	-8.93 (4.25)

0.03% Bimatoprost/0.5% Timolol in Same Bottle vs 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles: Mean Difference (Final Values): -0.556 (95% CI -1.68 to 0.57)

Population analysed: Intent to Treatment population defined as all patients randomized. One patient in the 0.03% Bimatoprost/0.5% Timolol in Same Bottle group was not included in the analysis.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
0.03% Bimatoprost/0.5% Timolol in Same Bottle	0 of 121 (0%)	30 of 121 (24.8%)	Not reported
0.03% Bimatoprost and 0.5% Timolol in Separate Bottles	2 of 114 (1.8%)	29 of 114 (25.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24571886Ling Z, Zhang M, Hu Y, Yin Z, Xing Y, Fang A, Ye J, Chen X, Liu D, Wang Y, Sun W, Dong Y, Sun X. Safety and efficacy of bimatoprost/timolol fixed combination in Chinese patients with open-angle glaucoma or ocular hypertension. Chin Med J (Engl). 2014;127(5):905-10.

Related trials for Open-angle Glaucoma

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
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle 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.

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?

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 3 inclusion and 6 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 17 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jan 2012). 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?

The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4 (time frame: Baseline, Week 4). 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 NCT01068964, 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 17 Apr 2019.