Ocular HypertensionPhase 1/2NCT00809848

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

A Phase 1/2 study testing AGN-210669 ophthalmic solution, 0.075%, AGN-210669 ophthalmic solution, 0.05% and AGN-210669 ophthalmic solution, 0.025% in people with Ocular Hypertension and 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

The study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution in comparison with AGN-210669 vehicle and bimatoprost ophthalmic solution dosed once-daily each morning, in subjects with ocular hypertension or primary open-angle glaucoma. Subjects will be followed for 2 weeks. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Ocular Hypertension, Glaucoma
What is being tested?: AGN-210669 ophthalmic solution, 0.075%, AGN-210669 ophthalmic solution, 0.05% and AGN-210669 ophthalmic solution, 0.025%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 172 participants
Where: 1 siteUnited States
Study dates: Feb 2009to May 2009
Phase: Phase 1/2
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Ocular hypertension or primary open-angle glaucoma
Females of non-childbearing potential
Subject requires IOP-lowering therapy in both eyes
IOP ≥ 22 mm Hg and ≤ 34 mm Hg
Has a visual acuity score of 20/100 or better in each eye

Who cannot join

Uncontrolled systemic disease
Active ocular disease
Alteration of existing chronic systemic medications
Known allergy or sensitivity to the study medications
Ophthalmic corticosteroids
Visual field loss which in the opinion of the investigator is functionally significant
History of ocular laser, intraocular surgery, or refractive surgery

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Artesia, California

Other trials in United States

About this study

Conditions: Ocular Hypertension, Glaucoma
Being tested: AGN-210669 ophthalmic solution, 0.075%, AGN-210669 ophthalmic solution, 0.05%, AGN-210669 ophthalmic solution, 0.025%, bimatoprost ophthalmic solution 0.03%, AGN-210669 vehicle ophthalmic solution
Medical subject headings: Ocular Hypertension, Glaucoma

What participants receive

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

AGN-210669 ophthalmic solution, 0.075%Drug
AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.
AGN-210669 ophthalmic solution, 0.05%Drug
AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
AGN-210669 ophthalmic solution, 0.025%Drug
AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
bimatoprost ophthalmic solution 0.03%Drug
Also called Lumigan®
Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
AGN-210669 vehicle ophthalmic solutionDrug
AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.

Study groups in NCT00809848
Study group	Role	What they receive
AGN-210669 ophthalmic solution, 0.075%	Experimental	AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks. Receives: Drug: AGN-210669 ophthalmic solution, 0.075%
AGN-210669 ophthalmic solution, 0.05%	Experimental	AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks. Receives: Drug: AGN-210669 ophthalmic solution, 0.05%
AGN-210669 ophthalmic solution, 0.025%	Experimental	AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks. Receives: Drug: AGN-210669 ophthalmic solution, 0.025%
bimatoprost ophthalmic solution 0.03%	Active comparator	Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks. Receives: Drug: bimatoprost ophthalmic solution 0.03%
AGN-210669 vehicle ophthalmic solution	Placebo comparator	AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks. Receives: Drug: AGN-210669 vehicle ophthalmic solution

What is being measured

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

Change From Baseline in Average Eye Intraocular Pressure (IOP)
IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes is 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).
Measured: Baseline, Day 14 Hour 0

Secondary outcomes (1)

Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP is the average of the IOP values of both eyes at each time point measured at protocol-specified times throughout the day.
Measured: Baseline, Day 14

Timeline

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

Feb 2009May 2009

First posted17 Dec 2008 (estimated)
Study startFeb 2009
Primary completionMay 2009
Study completionMay 2009

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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 172 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00809848
Sponsor's protocol ID: 210669-003
Status last verified: Aug 2013
First submitted: 16 Dec 2008
Last updated: 18 Oct 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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All Ocular Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of AGN 210669 Ophthalmic Solution in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma
ClinicalTrials.gov ID: NCT00809848
Acronym / sponsor ID: 210669-003
Conditions: Ocular Hypertension, Glaucoma
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 172 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Feb 2009
Primary completion: May 2009 (actual)
Study completion: May 2009 (actual)
First posted: 17 Dec 2008 (estimated)
Results: Posted 18 Oct 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: 5

Arm	Type	Receives
AGN-210669 ophthalmic solution, 0.075%	Experimental	Drug: AGN-210669 ophthalmic solution, 0.075%AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.
AGN-210669 ophthalmic solution, 0.05%	Experimental	Drug: AGN-210669 ophthalmic solution, 0.05%AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
AGN-210669 ophthalmic solution, 0.025%	Experimental	Drug: AGN-210669 ophthalmic solution, 0.025%AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
bimatoprost ophthalmic solution 0.03%	Active comparator	Drug: bimatoprost ophthalmic solution 0.03%Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
AGN-210669 vehicle ophthalmic solution	Placebo comparator	Drug: AGN-210669 vehicle ophthalmic solutionAGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Ocular hypertension or primary open-angle glaucoma
Females of non-childbearing potential
Subject requires IOP-lowering therapy in both eyes
IOP ≥ 22 mm Hg and ≤ 34 mm Hg
Has a visual acuity score of 20/100 or better in each eye

Key exclusion criteria (7 listed)

Uncontrolled systemic disease
Active ocular disease
Alteration of existing chronic systemic medications
Known allergy or sensitivity to the study medications
Ophthalmic corticosteroids

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-210669 ophthalmic solution, 0.075%AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.	Drug	AGN-210669 ophthalmic solution, 0.075%
AGN-210669 ophthalmic solution, 0.05%AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.	Drug	AGN-210669 ophthalmic solution, 0.05%
AGN-210669 ophthalmic solution, 0.025%AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.	Drug	AGN-210669 ophthalmic solution, 0.025%
bimatoprost ophthalmic solution 0.03%Also: Lumigan®Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.	Drug	bimatoprost ophthalmic solution 0.03%
AGN-210669 vehicle ophthalmic solutionAGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.	Drug	AGN-210669 vehicle ophthalmic solution

Primary outcome

Change From Baseline in Average Eye Intraocular Pressure (IOP)
Time frame: Baseline, Day 14 Hour 0
IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes is 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).

1 secondary outcome

Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP
Time frame: Baseline, Day 14

Results and safety

Results posted to the registry on 18 Oct 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 Ophthalmic Solution, 0.075%	36	36
AGN-210669 Ophthalmic Solution, 0.05%	34	34
AGN-210669 Ophthalmic Solution, 0.025%	34	34
Bimatoprost Ophthalmic Solution 0.03%	31	30
AGN-210669 Vehicle Ophthalmic Solution	37	34

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

Time frame: Baseline, Day 14 Hour 0. Mean (Standard Deviation). Unit: Millimeters of Mercury (mmHg)

Measure	AGN-210669 Ophthalmic Solution, 0.075% n = 35	AGN-210669 Ophthalmic Solution, 0.05% n = 33	AGN-210669 Ophthalmic Solution, 0.025% n = 33	Bimatoprost Ophthalmic Solution 0.03% n = 30	AGN-210669 Vehicle Ophthalmic Solution n = 36
Baseline - Hour 0	25.350 (2.8018)	25.318 (2.9377)	25.341 (2.6375)	24.650 (2.0622)	25.507 (2.9004)
Change from Baseline at Day 14 - Hour 0	-5.807 (3.7007)	-5.197 (3.1947)	-4.068 (2.8520)	-6.575 (3.2184)	-2.382 (2.9396)

Population analysed: Modified Intent to Treat: all randomized and treated patients who had at least a baseline visit and 1 postbaseline IOP evaluation

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 Ophthalmic Solution, 0.075%	0 of 36 (0%)	17 of 36 (47.2%)	Not reported
AGN-210669 Ophthalmic Solution, 0.05%	0 of 34 (0%)	18 of 34 (52.9%)	Not reported
AGN-210669 Ophthalmic Solution, 0.025%	0 of 34 (0%)	9 of 34 (26.5%)	Not reported
Bimatoprost Ophthalmic Solution 0.03%	0 of 31 (0%)	20 of 31 (64.5%)	Not reported
AGN-210669 Vehicle Ophthalmic Solution	0 of 37 (0%)	5 of 37 (13.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2013.
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 5 inclusion and 7 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 Oct 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 18 Oct 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 Intraocular Pressure (IOP) (time frame: Baseline, Day 14 Hour 0). 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 NCT00809848.

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 Oct 2013.