GlaucomaPhase 4NCT01525173

A Safety and Efficacy Study of ALPHAGAN® P and LUMIGAN® in Subjects Previously Treated With Latanoprost for Glaucoma and Ocular Hypertension

A Phase 4 study testing 0.1% brimonidine tartrate ophthalmic solution, 0.01% bimatoprost ophthalmic solution and 0.2% hypromellose lubricant eye drops 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 efficacy and safety of either bimatoprost 0.01% ophthalmic solution (Lumigan®) alone or bimatoprost 0.01% ophthalmic solution (Lumigan®) and brimonidine tartrate 0.1% ophthalmic solution (Alphagan® P) in combination in patients previously treated with latanoprost 0.005% ophthalmic solution… 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?: 0.1% brimonidine tartrate ophthalmic solution, 0.01% bimatoprost ophthalmic solution and 0.2% hypromellose lubricant eye drops
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 137 participants
Where: 1 siteUnited States
Study dates: Jan 2012to Oct 2012
Phase: Phase 4
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 glaucoma in at least 1 eye
Visual acuity of 20/100 or better in both eyes

Who cannot join

Corneal refractive laser surgery (LASIK, LASEK, PRK, RK) in the study eye(s)
Intraocular or glaucoma surgery in the past 3 months

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Deerfield Beach, Florida

Other trials in United States

About this study

Conditions: Glaucoma, Ocular Hypertension
Being tested: 0.1% brimonidine tartrate ophthalmic solution, 0.01% bimatoprost ophthalmic solution, 0.2% hypromellose lubricant eye drops, latanoprost 0.005% 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.

0.1% brimonidine tartrate ophthalmic solutionDrug
Also called ALPHAGAN® P
1 drop of 0.1% brimonidine tartrate ophthalmic solution 3 times per day for 12 weeks.
0.01% bimatoprost ophthalmic solutionDrug
Also called LUMIGAN®
1 drop of 0.01% bimatoprost ophthalmic solution once per day for 12 weeks.
0.2% hypromellose lubricant eye dropsDrug
Also called GenTeal ®
1 drop of 0.2% hypromellose lubricant eye drops 3 times per day for 12 weeks.
latanoprost 0.005% ophthalmic solutionDrug
1 drop of latanoprost 0.005% ophthalmic solution once daily as run-in therapy for 30 days only.

Study groups in NCT01525173
Study group	Role	What they receive
ALPHAGAN® P and LUMIGAN®	Active comparator	1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks. Receives: Drug: 0.1% brimonidine tartrate ophthalmic solution; Drug: 0.01% bimatoprost ophthalmic solution; Drug: latanoprost 0.005% ophthalmic solution
LUMIGAN® Alone	Active comparator	1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks. Receives: Drug: 0.01% bimatoprost ophthalmic solution; Drug: 0.2% hypromellose lubricant eye drops; Drug: latanoprost 0.005% ophthalmic solution

What is being measured

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

Change From Baseline in Mean Diurnal Intraocular Pressure (IOP)
IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the study eye, defined as the worse eye at Baseline. The mean diurnal IOP is the average of all the IOP measurements in the study eye taken at 8 AM, 10 AM and 4 PM at Baseline and at Week 12. A negative change from Baseline indicated improvement.
Measured: Baseline, Week 12

Timeline

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

Jan 2012Oct 2012

First posted2 Feb 2012 (estimated)
Study startJan 2012
Primary completionOct 2012
Study completionOct 2012

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 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 137 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01525173
Sponsor's protocol ID: GMA-LUM-11-019
Status last verified: Oct 2013
First submitted: 31 Jan 2012
Last updated: 4 Dec 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 Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Safety and Efficacy Study of ALPHAGAN® P and LUMIGAN® in Subjects Previously Treated With Latanoprost for Glaucoma and Ocular Hypertension
ClinicalTrials.gov ID: NCT01525173
Acronym / sponsor ID: GMA-LUM-11-019
Conditions: Glaucoma, Ocular Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 137 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Jan 2012
Primary completion: Oct 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 2 Feb 2012 (estimated)
Results: Posted 4 Dec 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: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
ALPHAGAN® P and LUMIGAN®	Active comparator	Drug: 0.1% brimonidine tartrate ophthalmic solution, Drug: 0.01% bimatoprost ophthalmic solution, Drug: latanoprost 0.005% ophthalmic solution1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
LUMIGAN® Alone	Active comparator	Drug: 0.01% bimatoprost ophthalmic solution, Drug: 0.2% hypromellose lubricant eye drops, Drug: latanoprost 0.005% ophthalmic solution1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.

Who may qualify

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

Key inclusion criteria (2 listed)

Ocular hypertension or glaucoma in at least 1 eye
Visual acuity of 20/100 or better in both eyes

Key exclusion criteria (2 listed)

Corneal refractive laser surgery (LASIK, LASEK, PRK, RK) in the study eye(s)
Intraocular or glaucoma surgery in the past 3 months

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
0.1% brimonidine tartrate ophthalmic solutionAlso: ALPHAGAN® P1 drop of 0.1% brimonidine tartrate ophthalmic solution 3 times per day for 12 weeks.	Drug	ALPHAGAN® P and LUMIGAN®
0.01% bimatoprost ophthalmic solutionAlso: LUMIGAN®1 drop of 0.01% bimatoprost ophthalmic solution once per day for 12 weeks.	Drug	ALPHAGAN® P and LUMIGAN®, LUMIGAN® Alone
0.2% hypromellose lubricant eye dropsAlso: GenTeal ®1 drop of 0.2% hypromellose lubricant eye drops 3 times per day for 12 weeks.	Drug	LUMIGAN® Alone
latanoprost 0.005% ophthalmic solution1 drop of latanoprost 0.005% ophthalmic solution once daily as run-in therapy for 30 days only.	Drug	ALPHAGAN® P and LUMIGAN®, LUMIGAN® Alone

Primary outcome

Change From Baseline in Mean Diurnal Intraocular Pressure (IOP)
Time frame: Baseline, Week 12
IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the study eye, defined as the worse eye at Baseline. The mean diurnal IOP is the average of all the IOP measurements in the study eye taken at 8 AM, 10 AM and 4 PM at Baseline and at Week 12. A negative change from Baseline indicated improvement.

Results and safety

Results posted to the registry on 4 Dec 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
ALPHAGAN® P and LUMIGAN®	70	63
LUMIGAN® Alone	67	62

Primary outcome: Change From Baseline in Mean Diurnal Intraocular Pressure (IOP)

Time frame: Baseline, Week 12. Mean (Standard Deviation). Unit: mm Hg

Measure	ALPHAGAN® P and LUMIGAN® n = 61	LUMIGAN® Alone n = 59
Baseline	22.3 (2.22)	22.2 (2.44)
Change from Baseline at Week 12	-4.7 (2.55)	-4.0 (3.23)

Population analysed: Per protocol population included all qualified participants who completed three months of treatment.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ALPHAGAN® P and LUMIGAN®	1 of 70 (1.4%)	4 of 70 (5.7%)	Not reported
LUMIGAN® Alone	2 of 67 (3%)	0 of 67 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 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 2 inclusion and 2 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 4 Dec 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 4 Dec 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 Mean Diurnal Intraocular Pressure (IOP) (time frame: Baseline, Week 12). 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 NCT01525173.

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 4 Dec 2013.