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:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01525173
First received: January 31, 2012
Last updated: October 7, 2013
Last verified: October 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01525173

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

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01525173     History of Changes
Other Study ID Numbers: GMA-LUM-11-019
Study First Received: January 31, 2012
Results First Received: October 7, 2013
Last Updated: October 7, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Ophthalmic Solutions
Tetrahydrozoline
Brimonidine
Latanoprost
Bimatoprost
Pharmaceutical Solutions
Cloprostenol
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular 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

ClinicalTrials.gov processed this record on August 20, 2014