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

Glaucoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01525173
• Other study ID #: GMA-LUM-11-019
• Status: Completed
• Phase: Phase 4
• First received: January 31, 2012
• Last updated: October 7, 2013
• Start date: January 2012
• Est. completion date: October 2012

Study information

• Verified date: October 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• 0.1% brimonidine tartrate ophthalmic solution
1 drop of 0.1% brimonidine tartrate ophthalmic solution 3 times per day for 12 weeks.
• 0.01% bimatoprost ophthalmic solution
1 drop of 0.01% bimatoprost ophthalmic solution once per day for 12 weeks.
• 0.2% hypromellose lubricant eye drops
1 drop of 0.2% hypromellose lubricant eye drops 3 times per day for 12 weeks.
• latanoprost 0.005% ophthalmic solution
1 drop of latanoprost 0.005% ophthalmic solution once daily as run-in therapy for 30 days only.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No