A Safety and Efficacy Study of Fixed-Combination Bimatoprost and Brimonidine in Chronic Glaucoma or Ocular Hypertension

NCT01863953 | Completed Phase 2 Results

• 1 other identifier: 192024-082
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

This is a safety and efficacy study of fixed-combination bimatoprost and brimonidine compared with LUMIGAN® and ALPHAGAN® in patients with chronic glaucoma or ocular hypertension.

Conditions

Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP)

  IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).

  Baseline, Day 42

Secondary Outcomes (2)

• Change From Baseline in Average Eye Mean Diurnal IOP

  Baseline, Day 14, Day 28

• Average Eye Mean Diurnal IOP

  Day 14, Day 28, Day 42

Study Arms (3)

Fixed-Combination Bimatoprost/Brimonidine

EXPERIMENTAL

One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.

Drug: Fixed-Combination Bimatoprost/Brimonidine

Bimatoprost Ophthalmic Solution 0.01% and Vehicle

ACTIVE COMPARATOR

One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.

Drug: Bimatoprost Ophthalmic Solution 0.01%; Drug: Vehicle Ophthalmic Solution

Brimonidine Tartrate Ophthalmic Solution 0.2%

ACTIVE COMPARATOR

One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.

Drug: Brimonidine Tartrate Ophthalmic Solution 0.2%

Interventions

Fixed-Combination Bimatoprost/Brimonidine DRUG

One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.

Fixed-Combination Bimatoprost/Brimonidine

Bimatoprost Ophthalmic Solution 0.01% DRUG

One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening for 6 weeks.

Also known as: LUMIGAN

Bimatoprost Ophthalmic Solution 0.01% and Vehicle

Vehicle Ophthalmic Solution DRUG

One drop vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.

Bimatoprost Ophthalmic Solution 0.01% and Vehicle

Brimonidine Tartrate Ophthalmic Solution 0.2% DRUG

One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.

Also known as: ALPHAGAN

Brimonidine Tartrate Ophthalmic Solution 0.2%

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of ocular hypertension or glaucoma
• Requires intraocular pressure (IOP)-lowering therapy

You may not qualify if:

• Cataract surgery in one eye
• Ocular laser or intraocular surgery within 6 months
• Refractive surgery in either eye
• Anticipated use of contact lenses during the study
• Expected use of artificial tears during the study

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Newport Beach, California, United States

Location

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Interventions

Brimonidine Tartrate; Bimatoprost

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: May 29, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 26, 2015
• Results First Posted: January 26, 2015

Record last verified: 2015-01

Locations

US (1)