Safety and Efficacy of Bimatoprost Compared With Latanoprost in Patients With Glaucoma or Ocular Hypertension

NCT00541242 | Completed Phase 4 Results

• 1 other identifier: 192024-034
• Study Type: interventional
• Target: 586
• Locations: 1 country
• Sites: 1

Brief Summary

The study will compare the safety and efficacy of Bimatoprost and Latanoprost in patients with glaucoma or ocular hypertension

Conditions

Ocular Hypertension; Glaucoma

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 12

  Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.

  Baseline, Week 12

• Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18

  Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.

  Baseline, Week 18

Study Arms (2)

1

ACTIVE COMPARATOR

bimatoprost 0.03% eye drops

Drug: bimatoprost 0.03% eye drops

2

ACTIVE COMPARATOR

latanoprost 0.005% eye drops

Drug: latanoprost 0.005% eye drops

Interventions

bimatoprost 0.03% eye drops DRUG

Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of bimatoprost 0.03% 1 drop every evening for 12 weeks

Also known as: latanoprost = Xalatan®, bimatoprost = Lumigan®

1

latanoprost 0.005% eye drops DRUG

Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of latanoprost 0.005% 1 drop every evening for 12 weeks

Also known as: Xalatan®

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ocular hypertension or chronic glaucoma
• Patient requires IOP-lowering therapy in both eyes

You may not qualify if:

• Uncontrolled medical conditions
• Hypersensitivity to study medications

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Newport Beach, California, United States

Location

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma

Interventions

Bimatoprost; Ophthalmic Solutions; Latanoprost

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Allergan, Inc.

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2007
• First Posted: October 10, 2007
• Study Start: December 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: October 27, 2011
• Results First Posted: October 27, 2011

Record last verified: 2011-09

Locations

US (1)