Safety and Efficacy Study of Different Formulations of Bimatoprost Once-Daily in Patients With Glaucoma or Ocular Hypertension

Glaucoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00652496
• Other study ID #: 192024-030
• Status: Completed
• Phase: Phase 2
• First received: April 1, 2008
• Last updated: April 1, 2008
• Start date: January 2005
• Est. completion date: May 2005

Study information

• Verified date: April 2008
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study evaluates the safety and efficacy of different formulations of bimatoprost ophthalmic solution compared with Bimatoprost 0.03% once-daily in patients with glaucoma or ocular hypertension. One of the test formulations was given to one eye and bimatoprost 0.03% given to the fellow eye of each patient

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ocular hypertension or glaucoma in both eyes

• Require IOP-lowering therapy in each eye

Exclusion Criteria:

• Uncontrolled systemic disease

• Known allergy or hypersensitivity to bimatoprost

Study Design

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

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• Bimatoprost 0.01% ophthalmic solution
One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop
• Bimatoprost 0.015% formulation 1 ophthalmic solution
One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop
• Bimatoprost 0.015% formulation 2 ophthalmic solution
One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop
• Bimatoprost 0.02% ophthalmic solution
One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop
• Bimatoprost 0.03% ophthalmic solution
Bimatoprost 0.03% ophthalmic solution, one drop in one eye, once daily in the morning for 4 consecutive days, the other eye received one drop of any of the 4 study drugs

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	Intraocular pressure (IOP)		Day 5	No
Secondary	Patient Comfort		Days 1-4	No
Secondary	Patient Satisfaction		Day 5	No
Secondary	Treatment Preference		Day 5	No