Safety and Efficacy of Bimatoprost Timolol Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension

NCT01068964 | Completed Results

• 1 other identifier: 192024-052
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety and efficacy of once daily administered 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution compared with once daily administered 0.03% Bimatoprost Ophthalmic Solution and once daily administered 0.5% Timolol Ophthalmic Solution concurrently in patients with open-angle glaucoma or ocular hypertension

Conditions

Open-angle Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4

  The difference of change from baseline of mean diurnal IOP between the 0.03% Bimatoprost/0.5% Timolol in Same Bottle and the 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles at week 4. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of the study eye (the eye with the highest IOP at baseline) over the 3 time points measured at 8AM, 12PM and 4PM. A negative number change from baseline indicated a reduction (improvement) in IOP. The difference of change from baseline in IOP is presented in the statistical analysis section.

  Baseline, Week 4

Study Arms (2)

0.03% Bimatoprost/0.5% Timolol in Same Bottle

EXPERIMENTAL

Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution

Drug: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution

0.03% Bimatoprost and 0.5% Timolol in Separate Bottles

ACTIVE COMPARATOR

Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution

Drug: 0.03% Bimatoprost Ophthalmic Solution and 0.5% Timolol Ophthalmic Solution

Interventions

0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution DRUG

One drop from each bottle, administered once daily in the evening for 4 weeks Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution

Also known as: Bottle 1: Ganfort®

0.03% Bimatoprost/0.5% Timolol in Same Bottle

0.03% Bimatoprost Ophthalmic Solution and 0.5% Timolol Ophthalmic Solution DRUG

One drop from each bottle, administered once daily in the evening for 4 weeks Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution

Also known as: Bottle 1: Lumigan®, Bottle 2: Timoptol®

0.03% Bimatoprost and 0.5% Timolol in Separate Bottles

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of open-angle glaucoma or ocular hypertension in one or both eyes
• Eye pressure lowering topical medications are not working
• Visual acuity is at least 0.2 in each eye

You may not qualify if:

• Uncontrolled systemic disease
• Any other active eye disease other than glaucoma or ocular hypertension
• Significant visual field loss or evidence of progressive visual field loss within the last year
• Anticipated wearing of contact lenses during the study
• Required chronic use of other ocular medications during the study
• Eye surgery or laser treatment within 12 weeks prior to study enrollment

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Beijing, China

Location

Related Publications (1)

• Ling Z, Zhang M, Hu Y, Yin Z, Xing Y, Fang A, Ye J, Chen X, Liu D, Wang Y, Sun W, Dong Y, Sun X. Safety and efficacy of bimatoprost/timolol fixed combination in Chinese patients with open-angle glaucoma or ocular hypertension. Chin Med J (Engl). 2014;127(5):905-10.

  PMID: 24571886 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

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: not applicable
• 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: February 12, 2010
• First Posted: February 17, 2010
• Study Start: February 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: April 17, 2019
• Results First Posted: January 20, 2012

Record last verified: 2019-04

Locations

CN (1)