GlaucomaPhase 3NCT01099774

Safety and Efficacy of Different Formulations of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

A Phase 3 study testing Bimatoprost 0.03% Formulation B Ophthalmic Solution and Bimatoprost 0.03% Ophthalmic Solution in people with Glaucoma and Ocular Hypertension, run by Allergan at 1 site in United States.

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 bimatoprost 0.03% formulation B ophthalmic solution with LUMIGAN® (bimatoprost ophthalmic solution 0.03%) once daily for 12 weeks in patients with glaucoma or ocular hypertension Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glaucoma, Ocular Hypertension
What is being tested?: Bimatoprost 0.03% Formulation B Ophthalmic Solution and Bimatoprost 0.03% Ophthalmic Solution
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 597 participants
Where: 1 siteUnited States
Study dates: 1 May 2010to 29 Apr 2011
Phase: Phase 3
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

Patient has ocular hypertension or glaucoma in both eyes
Requires IOP-lowering therapy in each eye

Who cannot join

Active or recurrent eye disease that would interfere with interpretation of study data in either eye
History of any eye surgery or laser in either eye within 6 months
Required chronic use of other eye medications during the study
Anticipated wearing of contact lenses during the study.
Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Newport Beach, California

Other trials in United States

About this study

Conditions: Glaucoma, Ocular Hypertension
Being tested: Bimatoprost 0.03% Formulation B Ophthalmic Solution, Bimatoprost 0.03% Ophthalmic Solution
Medical subject headings: Glaucoma, Ocular Hypertension

What participants receive

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

Bimatoprost 0.03% Formulation B Ophthalmic SolutionDrug
One drop administered in each eye, every evening, for 12 weeks
Bimatoprost 0.03% Ophthalmic SolutionDrug
Also called LUMIGAN®
One drop administered in each eye, every evening, for 12 weeks

Study groups in NCT01099774
Study group	Role	What they receive
Bimatoprost 0.03% Formulation B Ophthalmic Solution	Experimental	Bimatoprost 0.03% Formulation B Ophthalmic Solution Receives: Drug: Bimatoprost 0.03% Formulation B Ophthalmic Solution
Bimatoprost 0.03% Ophthalmic Solution	Active comparator	Bimatoprost 0.03% Ophthalmic Solution Receives: Drug: Bimatoprost 0.03% Ophthalmic Solution

What is being measured

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

Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12
Change from baseline in worse eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements in the worse eye were evaluated at hours 0, 2, and 8. A negative number change from baseline indicated a reduction in IOP, and a positive number change from baseline indicated an increase in IOP.
Measured: Baseline, Week 12
Average Eye IOP at Week 12
Average Eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. Baseline data are included for reference only.
Measured: Baseline, Week 12
Average Eye IOP at Week 6
Average Eye IOP at Week 6 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.
Measured: Week 6
Average Eye IOP at Week 2
Average Eye IOP at Week 2 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.
Measured: Week 2

Timeline

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

1 May 201029 Apr 2011

First posted8 Apr 2010 (estimated)
Study start1 May 2010
Primary completion29 Apr 2011
Study completion29 Apr 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 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 597 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01099774
Sponsor's protocol ID: 192024-048
Status last verified: Apr 2019
First submitted: 6 Apr 2010
Last updated: 17 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Day DG, Walters TR, Schwartz GF, Mundorf TK, Liu C, Schiffman RM, Bejanian M. Bimatoprost 0.03% preservative-free ophthalmic solution versus bimatoprost 0.03% ophthalmic solution (Lumigan) for glaucoma or ocular hypertension: a 12-week, randomised, double-masked trial. Br J Ophthalmol. 2013 Aug;97(8):989-93. doi: 10.1136/bjophthalmol-2012-303040. Epub 2013 Jun 6.
PubMed 23743437

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 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Different Formulations of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
ClinicalTrials.gov ID: NCT01099774
Acronym / sponsor ID: 192024-048
Conditions: Glaucoma, Ocular Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 597 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 1 May 2010 (actual)
Primary completion: 29 Apr 2011 (actual)
Study completion: 29 Apr 2011 (actual)
First posted: 8 Apr 2010 (estimated)
Results: Posted 27 Apr 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: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Bimatoprost 0.03% Formulation B Ophthalmic Solution	Experimental	Drug: Bimatoprost 0.03% Formulation B Ophthalmic SolutionBimatoprost 0.03% Formulation B Ophthalmic Solution
Bimatoprost 0.03% Ophthalmic Solution	Active comparator	Drug: Bimatoprost 0.03% Ophthalmic SolutionBimatoprost 0.03% Ophthalmic Solution

Who may qualify

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

Key inclusion criteria (2 listed)

Patient has ocular hypertension or glaucoma in both eyes
Requires IOP-lowering therapy in each eye

Key exclusion criteria (5 listed)

Active or recurrent eye disease that would interfere with interpretation of study data in either eye
History of any eye surgery or laser in either eye within 6 months
Required chronic use of other eye medications during the study
Anticipated wearing of contact lenses during the study.
Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days

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% Formulation B Ophthalmic SolutionOne drop administered in each eye, every evening, for 12 weeks	Drug	Bimatoprost 0.03% Formulation B Ophthalmic Solution
Bimatoprost 0.03% Ophthalmic SolutionAlso: LUMIGAN®One drop administered in each eye, every evening, for 12 weeks	Drug	Bimatoprost 0.03% Ophthalmic Solution

Primary outcome

Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12
Time frame: Baseline, Week 12
Change from baseline in worse eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements in the worse eye were evaluated at hours 0, 2, and 8. A negative number change from baseline indicated a reduction in IOP, and a positive number change from baseline indicated an increase in IOP.
Average Eye IOP at Week 12
Time frame: Baseline, Week 12
Average Eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. Baseline data are included for reference only.
Average Eye IOP at Week 6
Time frame: Week 6
Average Eye IOP at Week 6 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.
Average Eye IOP at Week 2
Time frame: Week 2
Average Eye IOP at Week 2 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.

Results and safety

Results posted to the registry on 27 Apr 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
Bimatoprost 0.03% Formulation B Ophthalmic Solution	302	296
Bimatoprost 0.03% Ophthalmic Solution	295	289

Primary outcome: Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12

Time frame: Baseline, Week 12. Mean (Standard Deviation). Unit: Millimeters of Mercury (mmHg)

Measure	Bimatoprost 0.03% Formulation B Ophthalmic Solution n = 295	Bimatoprost 0.03% Ophthalmic Solution n = 291
Baseline Hour 0	24.90 (2.364)	24.86 (2.161)
Baseline Hour 2	23.79 (2.992)	23.78 (2.753)
Baseline Hour 8	22.81 (3.168)	22.80 (3.301)
Change from Baseline Hour 0 at Week 12	-7.49 (2.900)	-7.77 (3.029)
Change from Baseline Hour 2 at Week 12	-7.06 (3.333)	-7.11 (3.192)
Change from Baseline Hour 8 at Week 12	-5.93 (3.432)	-6.06 (3.602)

Population analysed: Per Protocol Population: All randomized patients who did not have a protocol violation that significantly affected the conduct or the results of the trial.

Primary outcome: Average Eye IOP at Week 12

Time frame: Baseline, Week 12. Mean (Standard Deviation). Unit: Millimeters of Mercury (mmHg)

Measure	Bimatoprost 0.03% Formulation B Ophthalmic Solution n = 302	Bimatoprost 0.03% Ophthalmic Solution n = 295
Baseline Hour 0	24.53 (2.196)	24.46 (2.019)
Baseline Hour 2	23.30 (2.848)	23.26 (2.613)
Baseline Hour 8	22.31 (2.974)	22.29 (3.110)
Week 12 Hour 0	17.25 (2.804)	16.96 (2.886)
Week 12 Hour 2	16.51 (2.900)	16.55 (2.863)
Week 12 Hour 8	16.64 (2.820)	16.59 (2.735)

Population analysed: Intent to Treat Population: all randomized patients.

Primary outcome: Average Eye IOP at Week 6

Time frame: Week 6. Mean (Standard Deviation). Unit: Millimeters of Mercury (mmHg)

Measure	Bimatoprost 0.03% Formulation B Ophthalmic Solution n = 302	Bimatoprost 0.03% Ophthalmic Solution n = 295
Week 6 Hour 0	17.16 (2.967)	17.08 (2.957)
Week 6 Hour 2	16.52 (2.855)	16.45 (2.766)
Week 6 Hour 8	16.56 (2.838)	16.32 (2.702)

Population analysed: Intent to Treat Population: all randomized patients.

Primary outcome: Average Eye IOP at Week 2

Time frame: Week 2. Mean (Standard Deviation). Unit: Millimeters of Mercury (mmHg)

Measure	Bimatoprost 0.03% Formulation B Ophthalmic Solution n = 302	Bimatoprost 0.03% Ophthalmic Solution n = 295
Week 2 Hour 0	17.40 (2.732)	17.14 (2.677)
Week 2 Hour 2	16.68 (2.759)	16.43 (2.581)
Week 2 Hour 8	16.61 (2.766)	16.39 (2.795)

Population analysed: Intent to Treat Population: all randomized patients.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bimatoprost 0.03% Formulation B Ophthalmic Solution	2 of 301 (0.7%)	72 of 301 (23.9%)	Not reported
Bimatoprost 0.03% Ophthalmic Solution	5 of 295 (1.7%)	77 of 295 (26.1%)	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 23743437Day DG, Walters TR, Schwartz GF, Mundorf TK, Liu C, Schiffman RM, Bejanian M. Bimatoprost 0.03% preservative-free ophthalmic solution versus bimatoprost 0.03% ophthalmic solution (Lumigan) for glaucoma or ocular hypertension: a 12-week, randomised, double-masked trial. Br J Ophthalmol. 2013 Aug;97(8):989-93. doi: 10.1136/bjophthalmol-2012-303040. Epub 2013 Jun 6.

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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?

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 5 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 27 Apr 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?

Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 (time frame: Baseline, Week 12). The study lists 4 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 NCT01099774, 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.