Safety and Efficacy of Different Formulations of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

NCT01099774 | Completed Phase 3 Results

• 1 other identifier: 192024-048
• Study Type: interventional
• Target: 597
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety and efficacy of bimatoprost 0.03% formulation B ophthalmic solution with LUMIGAN® (bimatoprost ophthalmic solution 0.03%) once daily for 12 weeks in patients with glaucoma or ocular hypertension

Conditions

Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (4)

• Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12

  Change from baseline in worse eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements in the worse eye were evaluated at hours 0, 2, and 8. A negative number change from baseline indicated a reduction in IOP, and a positive number change from baseline indicated an increase in IOP.

  Baseline, Week 12

• Average Eye IOP at Week 12

  Average Eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. Baseline data are included for reference only.

  Baseline, Week 12

• Average Eye IOP at Week 6

  Average Eye IOP at Week 6 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.

  Week 6

• Average Eye IOP at Week 2

  Average Eye IOP at Week 2 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.

  Week 2

Study Arms (2)

Bimatoprost 0.03% Formulation B Ophthalmic Solution

EXPERIMENTAL

Bimatoprost 0.03% Formulation B Ophthalmic Solution

Drug: Bimatoprost 0.03% Formulation B Ophthalmic Solution

Bimatoprost 0.03% Ophthalmic Solution

ACTIVE COMPARATOR

Bimatoprost 0.03% Ophthalmic Solution

Drug: Bimatoprost 0.03% Ophthalmic Solution

Interventions

Bimatoprost 0.03% Formulation B Ophthalmic Solution DRUG

One drop administered in each eye, every evening, for 12 weeks

Bimatoprost 0.03% Formulation B Ophthalmic Solution

Bimatoprost 0.03% Ophthalmic Solution DRUG

One drop administered in each eye, every evening, for 12 weeks

Also known as: LUMIGAN®

Bimatoprost 0.03% Ophthalmic Solution

Eligibility Criteria

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

You may qualify if:

• Patient has ocular hypertension or glaucoma in both eyes
• Requires IOP-lowering therapy in each eye

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Newport Beach, California, United States

Location

Related Publications (1)

• Day DG, Walters TR, Schwartz GF, Mundorf TK, Liu C, Schiffman RM, Bejanian M. Bimatoprost 0.03% preservative-free ophthalmic solution versus bimatoprost 0.03% ophthalmic solution (Lumigan) for glaucoma or ocular hypertension: a 12-week, randomised, double-masked trial. Br J Ophthalmol. 2013 Aug;97(8):989-93. doi: 10.1136/bjophthalmol-2012-303040. Epub 2013 Jun 6.

  PMID: 23743437 BACKGROUND

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Interventions

Bimatoprost; Ophthalmic Solutions

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2010
• First Posted: April 8, 2010
• Study Start: May 1, 2010
• Primary Completion: April 29, 2011
• Study Completion: April 29, 2011
• Last Updated: April 17, 2019
• Results First Posted: April 27, 2012

Record last verified: 2019-04

Locations

US (1)