NCT01525173

Brief 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 monotherapy who require additional intraocular pressure (IOP) lowering medication.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

December 4, 2013

Completed
Last Updated

December 4, 2013

Status Verified

October 1, 2013

Enrollment Period

9 months

First QC Date

January 31, 2012

Results QC Date

October 7, 2013

Last Update Submit

October 7, 2013

Conditions

GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, Week 12

Study Arms (2)

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.

Drug: 0.1% brimonidine tartrate ophthalmic solutionDrug: 0.01% bimatoprost ophthalmic solutionDrug: 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.

Drug: 0.01% bimatoprost ophthalmic solutionDrug: 0.2% hypromellose lubricant eye dropsDrug: latanoprost 0.005% ophthalmic solution

Interventions

0.1% brimonidine tartrate ophthalmic solutionDRUG

1 drop of 0.1% brimonidine tartrate ophthalmic solution 3 times per day for 12 weeks.

Also known as: ALPHAGAN® P
ALPHAGAN® P and LUMIGAN®
0.01% bimatoprost ophthalmic solutionDRUG

1 drop of 0.01% bimatoprost ophthalmic solution once per day for 12 weeks.

Also known as: LUMIGAN®
ALPHAGAN® P and LUMIGAN®LUMIGAN® Alone
0.2% hypromellose lubricant eye dropsDRUG

1 drop of 0.2% hypromellose lubricant eye drops 3 times per day for 12 weeks.

Also known as: GenTeal ®
LUMIGAN® Alone
latanoprost 0.005% ophthalmic solutionDRUG

1 drop of latanoprost 0.005% ophthalmic solution once daily as run-in therapy for 30 days only.

ALPHAGAN® P and LUMIGAN®LUMIGAN® Alone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Deerfield Beach, Florida, United States

Location

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Interventions

BimatoprostLubricant Eye DropsLatanoprostOphthalmic Solutions

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

AmidesOrganic ChemicalsCloprostenolProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesLubricantsSpecialty Uses of Chemicals

Results Point of Contact

Title
Vice President Medical Affairs,
Organization
Allergan, Inc
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2012

First Posted

February 2, 2012

Study Start

January 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

December 4, 2013

Results First Posted

December 4, 2013

Record last verified: 2013-10

Locations

US(1)