A Study of the Safety and Efficacy of Bimatoprost in Patients With Glaucoma or Ocular Hypertension

NCT00538304 | Completed Phase 2 Results

• 1 other identifier: 192024-035
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief Summary

A one month study which will determine the safety and efficacy of bimatoprost eye drops in patients with glaucoma or ocular hypertension

Conditions

Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean Peak Macroscopic Conjunctival Hyperemia at Month 1

  Change from Baseline in macroscopic conjunctival hyperemia (or visible eye redness). Macroscopic conjunctival hyperemia is graded by the investigator who compares the patient's visual appearance of eye redness to standard photographs using a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). The peak change is calculated for each eye by subtracting the largest score across the hourly measurements at baseline from the largest score across the hourly measurements at month 1. A positive number severity grade change from baseline indicated an increase in redness.

  Baseline, Month 1

Secondary Outcomes (5)

• Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye at Month 1

  Month 1

• Change From Baseline in Mean Intraocular Pressure (IOP) at Month 1

  Baseline, Month 1

• Percentage of Physicians Who Were Very or Extremely Willing to Continue Patient on Drug, if Drug Were Marketed at Month 1

  Month 1

• Percentage of Patients Who Were Very or Extremely Willing to Use This Glaucoma Medication at Month 1

  Month 1

• Percentage of Patients Who Reported No Change in the Appearance of Their Eyes Since the Beginning of the Study at Month 1

  Month 1

Study Arms (2)

1

EXPERIMENTAL

bimatoprost eye drops

Drug: bimatoprost eye drops

2

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

bimatoprost eye drops DRUG

1 drop in each eye daily for 1 month

1

placebo DRUG

1 drop in each eye daily for 1 month

2

Eligibility Criteria

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

You may qualify if:

• Chronic glaucoma or ocular hypertension
• IOP controlled on Xalatan

You may not qualify if:

• Uncontrolled medical conditions
• Known hypersensitivity to study medications

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Atlanta, Georgia, United States

Location

Related Publications (1)

• Craven ER, Liu CC, Batoosingh A, Schiffman RM, Whitcup SM. A randomized, controlled comparison of macroscopic conjunctival hyperemia in patients treated with bimatoprost 0.01% or vehicle who were previously controlled on latanoprost. Clin Ophthalmol. 2010 Dec 6;4:1433-40. doi: 10.2147/OPTH.S14915.

  PMID: 21188155 BACKGROUND

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Condition Hierarchy (Ancestors)

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: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2007
• First Posted: October 2, 2007
• Study Start: November 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: April 23, 2019
• Results First Posted: October 27, 2011

Record last verified: 2019-04

Locations

US (1)