Ocular HypertensionPhase 2NCT01110499

Safety and Efficacy of AGN-210961 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

A Phase 2 study testing AGN-210961 Formulation 1, AGN-210961 Formulation 2 and AGN-210961 Formulation 3 in people with Ocular Hypertension and Primary Open-Angle Glaucoma, 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

Who is it for?: Ages 18 years and older
Conditions the study is for: Ocular Hypertension, Primary Open-Angle Glaucoma
What is being tested?: AGN-210961 Formulation 1, AGN-210961 Formulation 2 and AGN-210961 Formulation 3
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 163 participants
Where: 1 siteUnited States
Study dates: Jun 2010to Jun 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

Ocular hypertension or primary open-angle glaucoma in each eye

Who cannot join

Any active ocular disease
Anticipated wearing of contact lenses during study
Anticipated use of artificial tears during study
Contraindication to pupil dilatation

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

This study has 2 parts. Part 1 will evaluate the safety and IOP effects of 6 formulations of AGN-210961 ophthalmic solution in the study eye and bimatoprost ophthalmic solution 0.03% in the fellow eye for 7 consecutive days. Part 2 will evaluate the safety and IOP effects of a formulation (to be selected from part 1) of AGN-210961 in both eyes compared to bimatoprost ophthalmic solution 0.03% for 4 weeks.

Conditions: Ocular Hypertension, Primary Open-Angle Glaucoma
Being tested: AGN-210961 Formulation 1, AGN-210961 Formulation 2, AGN-210961 Formulation 3, AGN-210961 Formulation 4, AGN-210961 Formulation 5
Medical subject headings: Ocular Hypertension, Glaucoma, Open-Angle

What participants receive

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

AGN-210961 Formulation 1Drug
AGN-210961 Formulation 1 in one eye once daily for 7 days.
AGN-210961 Formulation 2Drug
AGN-210961 Formulation 2 in one eye once daily for 7 days.
AGN-210961 Formulation 3Drug
AGN-210961 Formulation 3 in one eye once daily for 7 days.
AGN-210961 Formulation 4Drug
AGN-210961 Formulation 4 in one eye once daily for 7 days.
AGN-210961 Formulation 5Drug
AGN-210961 Formulation 5 in one eye once daily for 7 days.
AGN-210961 Formulation 6Drug
AGN-210961 Formulation 6 in one eye once daily for 7 days.
AGN-210961 Formulation 7Drug
AGN-210961 Formulation 7 in both eyes once daily for 4 weeks.
bimatoprost ophthalmic solution 0.03%Drug
Also called LUMIGAN®
bimatoprost ophthalmic solution 0.03% (LUMIGAN®) in both eyes once daily for 4 weeks.

Study groups in NCT01110499
Study group	Role	What they receive
Part 1, AGN-210961 Formulation 1	Experimental	AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. Receives: Drug: AGN-210961 Formulation 1
Part 1, AGN-210961 Formulation 2	Experimental	AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. Receives: Drug: AGN-210961 Formulation 2
Part 1, AGN-210961 Formulation 3	Experimental	AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. Receives: Drug: AGN-210961 Formulation 3
Part 1, AGN-210961 Formulation 4	Experimental	AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. Receives: Drug: AGN-210961 Formulation 4
Part 1, AGN-210961 Formulation 5	Experimental	AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. Receives: Drug: AGN-210961 Formulation 5
Part 1, AGN-210961 Formulation 6	Experimental	AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. Receives: Drug: AGN-210961 Formulation 6
Part 2, AGN-210961 Formulation 7	Experimental	AGN-210961 Formulation 7 in both eyes once daily for 4 weeks. Receives: Drug: AGN-210961 Formulation 7
Part 2, bimatoprost ophthalmic solution 0.03%	Active comparator	bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks. Receives: Drug: bimatoprost ophthalmic solution 0.03%

What is being measured

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

Part 1: Change From Baseline in Intraocular Pressure (IOP)
IOP is a measurement of the fluid pressure inside the eye. Data are recorded at Hours 0, 2, 4, 6, 8, and 12. A negative number change from Baseline indicated a reduction in IOP (improvement). Data for bimatoprost-treated eyes are combined across groups.
Measured: Baseline, Day 7
Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP)
IOP is a measurement of the fluid pressure inside the eye. Average IOP is the average of the 2 eyes for each patient at each time point. A negative number change from Baseline indicates a reduction in IOP (improvement). Data are recorded at Hours 0, 2, 4, 6, 8, and 12.
Measured: Baseline, Day 29

Timeline

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

Jun 2010Jun 2011

First posted26 Apr 2010 (estimated)
Study startJun 2010
Primary completionMay 2011
Study completionJun 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 Ocular HypertensionStudies 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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 163 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01110499
Sponsor's protocol ID: 210961-002
Status last verified: Jul 2014
First submitted: 23 Apr 2010
Last updated: 5 Aug 2014
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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All Ocular Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of AGN-210961 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
ClinicalTrials.gov ID: NCT01110499
Acronym / sponsor ID: 210961-002
Conditions: Ocular Hypertension, Primary Open-Angle Glaucoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 163 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Jun 2010
Primary completion: May 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 26 Apr 2010 (estimated)
Results: Posted 5 Aug 2014

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, care provider, investigator)
Number of arms: 8

Arm	Type	Receives
Part 1, AGN-210961 Formulation 1	Experimental	Drug: AGN-210961 Formulation 1AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Part 1, AGN-210961 Formulation 2	Experimental	Drug: AGN-210961 Formulation 2AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Part 1, AGN-210961 Formulation 3	Experimental	Drug: AGN-210961 Formulation 3AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Part 1, AGN-210961 Formulation 4	Experimental	Drug: AGN-210961 Formulation 4AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Part 1, AGN-210961 Formulation 5	Experimental	Drug: AGN-210961 Formulation 5AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Part 1, AGN-210961 Formulation 6	Experimental	Drug: AGN-210961 Formulation 6AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Part 2, AGN-210961 Formulation 7	Experimental	Drug: AGN-210961 Formulation 7AGN-210961 Formulation 7 in both eyes once daily for 4 weeks.
Part 2, bimatoprost ophthalmic solution 0.03%	Active comparator	Drug: bimatoprost ophthalmic solution 0.03%bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.

Who may qualify

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

Key inclusion criteria (1 listed)

Ocular hypertension or primary open-angle glaucoma in each eye

Key exclusion criteria (4 listed)

Any active ocular disease
Anticipated wearing of contact lenses during study
Anticipated use of artificial tears during study
Contraindication to pupil dilatation

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-210961 Formulation 1AGN-210961 Formulation 1 in one eye once daily for 7 days.	Drug	Part 1, AGN-210961 Formulation 1
AGN-210961 Formulation 2AGN-210961 Formulation 2 in one eye once daily for 7 days.	Drug	Part 1, AGN-210961 Formulation 2
AGN-210961 Formulation 3AGN-210961 Formulation 3 in one eye once daily for 7 days.	Drug	Part 1, AGN-210961 Formulation 3
AGN-210961 Formulation 4AGN-210961 Formulation 4 in one eye once daily for 7 days.	Drug	Part 1, AGN-210961 Formulation 4
AGN-210961 Formulation 5AGN-210961 Formulation 5 in one eye once daily for 7 days.	Drug	Part 1, AGN-210961 Formulation 5
AGN-210961 Formulation 6AGN-210961 Formulation 6 in one eye once daily for 7 days.	Drug	Part 1, AGN-210961 Formulation 6
AGN-210961 Formulation 7AGN-210961 Formulation 7 in both eyes once daily for 4 weeks.	Drug	Part 2, AGN-210961 Formulation 7
bimatoprost ophthalmic solution 0.03%Also: LUMIGAN®bimatoprost ophthalmic solution 0.03% (LUMIGAN®) in both eyes once daily for 4 weeks.	Drug	Part 2, bimatoprost ophthalmic solution 0.03%

Primary outcome

Part 1: Change From Baseline in Intraocular Pressure (IOP)
Time frame: Baseline, Day 7
IOP is a measurement of the fluid pressure inside the eye. Data are recorded at Hours 0, 2, 4, 6, 8, and 12. A negative number change from Baseline indicated a reduction in IOP (improvement). Data for bimatoprost-treated eyes are combined across groups.
Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP)
Time frame: Baseline, Day 29
IOP is a measurement of the fluid pressure inside the eye. Average IOP is the average of the 2 eyes for each patient at each time point. A negative number change from Baseline indicates a reduction in IOP (improvement). Data are recorded at Hours 0, 2, 4, 6, 8, and 12.

Results and safety

Results posted to the registry on 5 Aug 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
Part 1, AGN-210961 Formulation 1	14	14
Part 1, AGN-210961 Formulation 2	14	14
Part 1, AGN-210961 Formulation 3	14	14
Part 1, AGN-210961 Formulation 4	14	14
Part 1, AGN-210961 Formulation 5	14	14
Part 1, AGN-210961 Formulation 6	14	14
Part 2, AGN-210961 Formulation 7	39	39
Part 2, Bimatoprost Ophthalmic Solution 0.03%	40	40

Primary outcome: Part 1: Change From Baseline in Intraocular Pressure (IOP)

Time frame: Baseline, Day 7. Mean (Standard Deviation). Unit: Millimeters of Mercury (mmHg)

Measure	Part 1, AGN-210961 Formulation 1 n = 14	Part 1, AGN-210961 Formulation 2 n = 14	Part 1, AGN-210961 Formulation 3 n = 14	Part 1, AGN-210961 Formulation 4 n = 14	Part 1, AGN-210961 Formulation 5 n = 14	Part 1, AGN-210961 Formulation 6 n = 14	Part 1, Bimatoprost Ophthalmic Solution 0.03% n = 84
Baseline - Hour 0	25.4 (2.5)	25.6 (2.71)	24.3 (1.94)	26.7 (3.60)	24.4 (1.54)	25.3 (2.23)	25.3 (2.82)
Baseline - Hour 2	23.1 (2.18)	23.5 (2.53)	23.6 (2.64)	23.6 (3.27)	23.1 (3.49)	24.1 (3.25)	23.4 (2.83)
Baseline - Hour 4	23.5 (2.53)	23.1 (2.55)	23.6 (3.64)	23.0 (3.72)	23.1 (2.46)	23.7 (2.49)	23.2 (2.76)
Baseline - Hour 6	22.0 (2.53)	22.0 (2.46)	24.4 (4.43)	21.9 (3.88)	22.1 (2.60)	22.4 (2.72)	22.5 (3.33)
Baseline - Hour 8	21.6 (2.84)	21.3 (2.58)	23.2 (3.87)	22.1 (4.04)	22.2 (2.83)	22.9 (2.95)	22.3 (3.18)
Baseline - Hour 12	22.1 (2.98)	21.6 (3.03)	21.8 (3.86)	21.6 (4.24)	21.3 (1.98)	20.8 (2.44)	21.5 (3.10)
Change from Baseline at Day 7- Hour 0	-6.1 (4.22)	-6.3 (4.24)	-5.9 (4.36)	-6.0 (3.87)	-5.2 (3.79)	-5.6 (3.16)	-6.3 (3.66)
Change from Baseline at Day 7- Hour 2	-5.3 (3.00)	-6.6 (2.88)	-6.0 (2.72)	-5.6 (2.80)	-5.3 (3.97)	-5.2 (3.71)	-5.0 (3.06)

Population analysed: Safety Population: all treated patients

Primary outcome: Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP)

Time frame: Baseline, Day 29. Mean (Standard Deviation). Unit: Millimeters of Mercury (mmHg)

Measure	Part 2, AGN-210961 Formulation 7 n = 39	Part 2, Bimatoprost Ophthalmic Solution 0.03% n = 40
Baseline - Hour 0	24.63 (2.526)	24.62 (2.465)
Baseline - Hour 2	23.40 (2.072)	23.70 (3.182)
Baseline - Hour 4	22.25 (2.449)	22.51 (3.507)
Baseline - Hour 6	21.97 (2.264)	22.38 (3.492)
Baseline - Hour 8	21.28 (2.896)	21.48 (3.354)
Baseline - Hour 12	20.72 (3.162)	20.94 (3.549)
Change from Baseline at Day 29 - Hour 0	-7.44 (3.173)	-8.63 (3.399)
Change from Baseline at Day 29 - Hour 2	-7.40 (3.269)	-8.51 (3.752)

Population analysed: Modified Intent to Treat: all randomized and treated patients who provided IOP data for baseline and at least one postbaseline hour 0 assessment

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1, AGN-210961 Formulation 1	0 of 14 (0%)	10 of 14 (71.4%)	Not reported
Part 1, AGN-210961 Formulation 2	0 of 14 (0%)	9 of 14 (64.3%)	Not reported
Part 1, AGN-210961 Formulation 3	0 of 14 (0%)	10 of 14 (71.4%)	Not reported
Part 1, AGN-210961 Formulation 4	0 of 14 (0%)	6 of 14 (42.9%)	Not reported
Part 1, AGN-210961 Formulation 5	0 of 14 (0%)	7 of 14 (50%)	Not reported
Part 1, AGN-210961 Formulation 6	0 of 14 (0%)	5 of 14 (35.7%)	Not reported
Part 1, Bimatoprost Ophthalmic Solution 0.03% Treated Eye	0 of 84 (0%)	53 of 84 (63.1%)	Not reported
Part 2, AGN-210961 Formulation 7	1 of 39 (2.6%)	29 of 39 (74.4%)	Not reported
Part 2, Bimatoprost Ophthalmic Solution 0.03%	1 of 40 (2.5%)	19 of 40 (47.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 1 inclusion and 4 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 5 Aug 2014. 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 5 Aug 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?

Part 1: Change From Baseline in Intraocular Pressure (IOP) (time frame: Baseline, Day 7). The study lists 2 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 NCT01110499.

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 5 Aug 2014.