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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

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ClinicalTrials.gov Identifier: NCT01525173
Recruitment Status : Completed
First Posted : February 2, 2012
Results First Posted : December 4, 2013
Last Update Posted : December 4, 2013
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Glaucoma
Ocular Hypertension
Interventions 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
Enrollment 137
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ALPHAGAN® P and LUMIGAN® LUMIGAN® Alone
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 70 67
Completed 63 62
Not Completed 7 5
Arm/Group Title ALPHAGAN® P and LUMIGAN® LUMIGAN® Alone Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 70 67 137
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 70 participants 67 participants 137 participants
65.7  (11.87) 61.1  (13.91) 63.4  (13.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 67 participants 137 participants
Female
31
  44.3%
33
  49.3%
64
  46.7%
Male
39
  55.7%
34
  50.7%
73
  53.3%
1.Primary Outcome
Title Change From Baseline in Mean Diurnal Intraocular Pressure (IOP)
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population included all qualified participants who completed three months of treatment.
Arm/Group Title ALPHAGAN® P and LUMIGAN® LUMIGAN® Alone
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 61 59
Mean (Standard Deviation)
Unit of Measure: mm Hg
Baseline 22.3  (2.22) 22.2  (2.44)
Change from Baseline at Week 12 -4.7  (2.55) -4.0  (3.23)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ALPHAGAN® P and LUMIGAN® LUMIGAN® Alone
Hide Arm/Group Description 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. 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.
All-Cause Mortality
ALPHAGAN® P and LUMIGAN® LUMIGAN® Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ALPHAGAN® P and LUMIGAN® LUMIGAN® Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   1/70 (1.43%)   2/67 (2.99%) 
Cardiac disorders     
Prolonged hospitalization cardiac ischemia   0/70 (0.00%)  1/67 (1.49%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Esophageal cancer   1/70 (1.43%)  0/67 (0.00%) 
Psychiatric disorders     
Exacerbation of depression disorder *  0/70 (0.00%)  1/67 (1.49%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ALPHAGAN® P and LUMIGAN® LUMIGAN® Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   4/70 (5.71%)   0/67 (0.00%) 
Eye disorders     
Ocular hyperemia   4/70 (5.71%)  0/67 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vice President Medical Affairs,
Organization: Allergan, Inc
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal 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