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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01525173
First Posted: February 2, 2012
Last Update Posted: December 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  Purpose
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.

Condition Intervention Phase
Glaucoma Ocular Hypertension Drug: 0.1% brimonidine tartrate ophthalmic solution Drug: 0.01% bimatoprost ophthalmic solution Drug: 0.2% hypromellose lubricant eye drops Drug: latanoprost 0.005% ophthalmic solution Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • 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.


Enrollment: 137
Study Start Date: January 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ALPHAGAN® P and LUMIGAN®
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 solution
1 drop of 0.1% brimonidine tartrate ophthalmic solution 3 times per day for 12 weeks.
Other Name: ALPHAGAN® P
Drug: 0.01% bimatoprost ophthalmic solution
1 drop of 0.01% bimatoprost ophthalmic solution once per day for 12 weeks.
Other Name: LUMIGAN®
Drug: latanoprost 0.005% ophthalmic solution
1 drop of latanoprost 0.005% ophthalmic solution once daily as run-in therapy for 30 days only.
Active Comparator: LUMIGAN® Alone
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 solution
1 drop of 0.01% bimatoprost ophthalmic solution once per day for 12 weeks.
Other Name: LUMIGAN®
Drug: 0.2% hypromellose lubricant eye drops
1 drop of 0.2% hypromellose lubricant eye drops 3 times per day for 12 weeks.
Other Name: GenTeal ®
Drug: latanoprost 0.005% ophthalmic solution
1 drop of latanoprost 0.005% ophthalmic solution once daily as run-in therapy for 30 days only.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Corneal refractive laser surgery (LASIK, LASEK, PRK, RK) in the study eye(s)
  • Intraocular or glaucoma surgery in the past 3 months
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01525173


Locations
United States, Florida
Deerfield Beach, Florida, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01525173     History of Changes
Other Study ID Numbers: GMA-LUM-11-019
First Submitted: January 31, 2012
First Posted: February 2, 2012
Results First Submitted: October 7, 2013
Results First Posted: December 4, 2013
Last Update Posted: December 4, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Hypertension
Glaucoma
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Tetrahydrozoline
Pharmaceutical Solutions
Ophthalmic Solutions
Latanoprost
Bimatoprost
Brimonidine Tartrate
Lubricant Eye Drops
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action