Safety and Efficacy of Different Formulations of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

Glaucoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01099774
• Other study ID #: 192024-048
• Status: Completed
• Phase: Phase 3
• Start date: May 1, 2010
• Est. completion date: April 29, 2011

Study information

• Verified date: April 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and efficacy of bimatoprost 0.03% formulation B ophthalmic solution with LUMIGAN® (bimatoprost ophthalmic solution 0.03%) once daily for 12 weeks in patients with glaucoma or ocular hypertension

Recruitment information / eligibility

• Status: Completed
• Enrollment: 597
• Est. completion date: April 29, 2011
• Est. primary completion date: April 29, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient has ocular hypertension or glaucoma in both eyes

• Requires IOP-lowering therapy in each eye

Exclusion Criteria:

• Active or recurrent eye disease that would interfere with interpretation of study data in either eye

• History of any eye surgery or laser in either eye within 6 months

• Required chronic use of other eye medications during the study

• Anticipated wearing of contact lenses during the study.

• Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• Bimatoprost 0.03% Formulation B Ophthalmic Solution
One drop administered in each eye, every evening, for 12 weeks
• Bimatoprost 0.03% Ophthalmic Solution
One drop administered in each eye, every evening, for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

References & Publications (1)

Day DG, Walters TR, Schwartz GF, Mundorf TK, Liu C, Schiffman RM, Bejanian M. Bimatoprost 0.03% preservative-free ophthalmic solution versus bimatoprost 0.03% ophthalmic solution (Lumigan) for glaucoma or ocular hypertension: a 12-week, randomised, double-masked trial. Br J Ophthalmol. 2013 Aug;97(8):989-93. doi: 10.1136/bjophthalmol-2012-303040. Epub 2013 Jun 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12	Change from baseline in worse eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements in the worse eye were evaluated at hours 0, 2, and 8. A negative number change from baseline indicated a reduction in IOP, and a positive number change from baseline indicated an increase in IOP.	Baseline, Week 12
Primary	Average Eye IOP at Week 12	Average Eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. Baseline data are included for reference only.	Baseline, Week 12
Primary	Average Eye IOP at Week 6	Average Eye IOP at Week 6 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.	Week 6
Primary	Average Eye IOP at Week 2	Average Eye IOP at Week 2 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.	Week 2