Safety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

• ClinicalTrials.gov Identifier: NCT01177098
• Recruitment Status: Completed
• First Posted: August 6, 2010
• Results First Posted: March 12, 2013
• Last Update Posted: March 29, 2013
• Sponsor: Allergan
• Information provided by (Responsible Party): Allergan

Study Description

Brief Summary:

This study will evaluate the safety and efficacy of bimatoprost/timolol formulation A ophthalmic solution with Ganfort® (bimatoprost 0.03%/timolol 0.5% ophthalmic solution) once daily for 12 weeks in patients with glaucoma or ocular hypertension.

Condition or disease	Intervention/treatment	Phase
Glaucoma; Ocular Hypertension	Drug: bimatoprost /timolol formulation A fixed combination ophthalmic solution; Drug: bimatoprost/timolol fixed combination ophthalmic solution	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 561 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: October 2010
• Actual Primary Completion Date: February 2012
• Actual Study Completion Date: February 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: bimatoprost/timolol formulation A; One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.	Drug: bimatoprost /timolol formulation A fixed combination ophthalmic solution; One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
Active Comparator: bimatoprost/timolol fixed combination ophthalmic solution; One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.	Drug: bimatoprost/timolol fixed combination ophthalmic solution; One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.; Other Name: GANFORT®

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 [ Time Frame: Baseline, Week 12 ]
   Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).
2. Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2 [ Time Frame: Week 2 ]
   Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 2 at Hour 0, Hour 2 and Hour 8.
3. Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6 [ Time Frame: Week 6 ]
   Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 6 at Hour 0, Hour 2 and Hour 8.
4. Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 [ Time Frame: Week 12 ]
   Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 12 at Hour 0, Hour 2 and Hour 8.

Secondary Outcome Measures :

1. Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12 [ Time Frame: Baseline, Week 12 ]
   Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).
2. Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12 [ Time Frame: Baseline, Week 12 ]
   Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8. Average eye IOP is defined as the average of the IOP in both eyes. A negative number change from baseline indicates a reduction in IOP (improvement).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, California

Artesia, California, United States

Australia, New South Wales

Sydney, New South Wales, Australia

Czech Republic

Brno, Czech Republic

Germany

Leipzig, Germany

Hungary

Budapest, Hungary

Israel

Tel Aviv, Israel

Russian Federation

Saint-Petersburg, Russian Federation

Spain

Valencia, Spain

United Kingdom

London, England, United Kingdom

Sponsors and Collaborators

Allergan

Investigators

• Study Director: Medical Director; Allergan

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Goldberg I, Gil Pina R, Lanzagorta-Aresti A, Schiffman RM, Liu C, Bejanian M. Bimatoprost 0.03%/timolol 0.5% preservative-free ophthalmic solution versus bimatoprost 0.03%/timolol 0.5% ophthalmic solution (Ganfort) for glaucoma or ocular hypertension: a 12-week randomised controlled trial. Br J Ophthalmol. 2014 Jul;98(7):926-31. doi: 10.1136/bjophthalmol-2013-304064. Epub 2014 Mar 25.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01177098
• Other Study ID Numbers: 192024-050; 2010-021507-24 ( EudraCT Number )
• First Posted: August 6, 2010
• Results First Posted: March 12, 2013
• Last Update Posted: March 29, 2013
• Last Verified: March 2013

Additional relevant MeSH terms:

Glaucoma; Ocular Hypertension; Hypertension; Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Timolol; Bimatoprost; Pharmaceutical Solutions; Ophthalmic Solutions; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Antihypertensive Agents