Glaucoma, Open-AnglePhase 2NCT01291108

Safety and Efficacy of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension

A Phase 2 study testing AGN-210669 and bimatoprost in people with Glaucoma, Open-Angle 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 AGN-210669 ophthalmic solution compared with bimatoprost ophthalmic solution (Lumigan®) as monotherapy and adjunctive therapy in patients with primary open-angle glaucoma or 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?: AGN-210669 and bimatoprost
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 125 participants
Where: 1 siteUnited States
Study dates: Apr 2011to Oct 2011
Phase: Phase 2
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 primary open-angle glaucoma or ocular hypertension in each eye
Requires bilateral treatment with an IOP-lowering medication
Best corrected visual acuity of 20/100 or better in each eye

Who cannot join

Use of oral, intramuscular, intravenous or topical ophthalmic corticosteroids within 2 months
Inability to fast for up to 10 hours
Prior refractive laser surgery (eg, LASIK, radial keratectomy, photorefractive keratectomy)
Intraocular surgery or IOP-lowering laser surgery (eg, laser trabeculoplasty) within 6 months
Current or anticipated use of artificial tears or any ocular medications aside from study medications during study
Anticipated wearing of contact lenses during study

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Austin, Texas

Other trials in United States

About this study

Conditions: Glaucoma, Open-Angle, Ocular Hypertension
Being tested: AGN-210669, bimatoprost, bimatoprost vehicle
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.

AGN-210669Drug
AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1 or Month 2.
bimatoprostDrug
Also called LUMIGAN®
bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1 or Month 2.
bimatoprost vehicleDrug
bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop in both eyes every evening during Month 2.

Study groups in NCT01291108
Study group	Role	What they receive
AGN-210669	Experimental	AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1. Receives: Drug: AGN-210669
AGN-210669 + bimatoprost	Experimental	AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2. Receives: Drug: AGN-210669; Drug: bimatoprost
AGN-210669 + bimatoprost vehicle	Experimental	AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2. Receives: Drug: AGN-210669; Drug: bimatoprost vehicle
bimatoprost	Active comparator	bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1. Receives: Drug: bimatoprost
bimatoprost + AGN-210669	Experimental	bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2. Receives: Drug: AGN-210669; Drug: bimatoprost
bimatoprost + bimatoprost vehicle	Other	bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2. Receives: Drug: bimatoprost; Drug: bimatoprost vehicle

What is being measured

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

Change From Baseline in Average Eye IOP
IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes are used for the analyses. 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). Data are recorded at Hours 0, 4, 8, and 12.
Measured: Baseline, Day 57

Secondary outcomes (1)

Change From Baseline in Worse Eye IOP
IOP is a measurement of the fluid pressure inside the eye. The worse eye IOP refers to eye with the worse baseline IOP, which is determined as the eye with the higher mean diurnal IOP at baseline. If both eyes have the same mean diurnal IOP at baseline, the right eye is designated as the worse 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). Data are recorded at Hours 0, 4, 8, and 12.
Measured: Baseline, Day 57

Timeline

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

Apr 2011Oct 2011

First posted8 Feb 2011 (estimated)
Study startApr 2011
Primary completionOct 2011
Study completionOct 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, 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 125 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01291108
Sponsor's protocol ID: 210669-013
Status last verified: Nov 2013
First submitted: 4 Feb 2011
Last updated: 6 Nov 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

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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
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
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RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
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Active, not recruitingObservational study
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All Glaucoma, Open-Angle trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
ClinicalTrials.gov ID: NCT01291108
Acronym / sponsor ID: 210669-013
Conditions: Glaucoma, Open-Angle, Ocular Hypertension
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 125 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Apr 2011
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 8 Feb 2011 (estimated)
Results: Posted 6 Nov 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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
AGN-210669	Experimental	Drug: AGN-210669AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1.
AGN-210669 + bimatoprost	Experimental	Drug: AGN-210669, Drug: bimatoprostAGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2.
AGN-210669 + bimatoprost vehicle	Experimental	Drug: AGN-210669, Drug: bimatoprost vehicleAGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
bimatoprost	Active comparator	Drug: bimatoprostbimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1.
bimatoprost + AGN-210669	Experimental	Drug: AGN-210669, Drug: bimatoprostbimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2.
bimatoprost + bimatoprost vehicle	Other	Drug: bimatoprost, Drug: bimatoprost vehiclebimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.

Who may qualify

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

Key inclusion criteria (3 listed)

Diagnosis of primary open-angle glaucoma or ocular hypertension in each eye
Requires bilateral treatment with an IOP-lowering medication
Best corrected visual acuity of 20/100 or better in each eye

Key exclusion criteria (6 listed)

Use of oral, intramuscular, intravenous or topical ophthalmic corticosteroids within 2 months
Inability to fast for up to 10 hours
Prior refractive laser surgery (eg, LASIK, radial keratectomy, photorefractive keratectomy)
Intraocular surgery or IOP-lowering laser surgery (eg, laser trabeculoplasty) within 6 months
Current or anticipated use of artificial tears or any ocular medications aside from study medications during 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
AGN-210669AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1 or Month 2.	Drug	AGN-210669, AGN-210669 + bimatoprost, AGN-210669 + bimatoprost vehicle, bimatoprost + AGN-210669
bimatoprostAlso: LUMIGAN®bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1 or Month 2.	Drug	AGN-210669 + bimatoprost, bimatoprost, bimatoprost + AGN-210669, bimatoprost + bimatoprost vehicle
bimatoprost vehiclebimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop in both eyes every evening during Month 2.	Drug	AGN-210669 + bimatoprost vehicle, bimatoprost + bimatoprost vehicle

Primary outcome

Change From Baseline in Average Eye IOP
Time frame: Baseline, Day 57
IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes are used for the analyses. 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). Data are recorded at Hours 0, 4, 8, and 12.

1 secondary outcome

Change From Baseline in Worse Eye IOP
Time frame: Baseline, Day 57

Results and safety

Results posted to the registry on 6 Nov 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
AGN-210669	65	64
AGN-210669 + Bimatoprost	0	0
AGN-210669 + Bimatoprost Vehicle	0	0
Bimatoprost	60	60
Bimatoprost + AGN-210669	0	0
Bimatoprost + Bimatoprost Vehicle	0	0

Primary outcome: Change From Baseline in Average Eye IOP

Time frame: Baseline, Day 57. Mean (Standard Deviation). Unit: Millimeters of Mercury (mmHg)

Measure	AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle n = 24	Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle n = 26	Combined Adjunctives n = 75
Baseline - Hour 0	26.16 (2.169)	25.98 (1.962)	26.26 (2.446)
Baseline - Hour 4	23.91 (2.382)	23.82 (2.301)	23.85 (2.553)
Baseline - Hour 8	22.49 (1.338)	22.35 (2.024)	22.79 (2.391)
Baseline - Hour 12	21.48 (2.467)	22.07 (2.596)	21.73 (2.624)
Change from Baseline at Day 57-Hr 0 (n=24,25,72)	-7.57 (2.881)	-10.28 (3.190)	-10.84 (3.460)
Change from Baseline at Day 57-Hr 4 (n=24,25,72)	-6.95 (2.503)	-8.95 (3.531)	-8.79 (3.330)
Change from Baseline at Day 57-Hr 8 (n=24,25,72)	-5.57 (3.484)	-7.19 (3.198)	-7.67 (2.596)
Change from Baseline at Day 57-Hr 12 (n=16,17,56)	-5.31 (2.690)	-6.87 (2.838)	-6.03 (2.642)

Population analysed: Modified Intent to Treat: all randomized and treated patients who had a baseline and at least 1 post-baseline IOP measurement

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
AGN-210669	0 of 65 (0%)	43 of 65 (66.2%)	Not reported
AGN-210669 + Bimatoprost	0 of 40 (0%)	31 of 40 (77.5%)	Not reported
AGN-210669 + Bimatoprost Vehicle	0 of 24 (0%)	11 of 24 (45.8%)	Not reported
Bimatoprost	0 of 60 (0%)	41 of 60 (68.3%)	Not reported
Bimatoprost + AGN-210669	0 of 34 (0%)	26 of 34 (76.5%)	Not reported
Bimatoprost + Bimatoprost Vehicle	1 of 26 (3.8%)	15 of 26 (57.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Glaucoma, Open-Angle

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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 2 study testing AGN-210669 and bimatoprost in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Allergan at 1 site in United States.

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 6 Nov 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 6 Nov 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?

Change From Baseline in Average Eye IOP (time frame: Baseline, Day 57). 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 NCT01291108.

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 6 Nov 2013.