A Safety and Efficacy Study of Bimatoprost 0.01% in Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH)

NCT01594970 | Completed Phase 4 Results

• 1 other identifier: APMA-001211
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety and efficacy of bimatoprost 0.01% in subjects with elevated intraocular pressure (IOP) due to primary open-angle glaucoma (POAG) or ocular hypertension (OH).

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale

  Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5 point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of participants in each severity grade are presented.

  Week 12

Secondary Outcomes (2)

• Change From Baseline in Intraocular Pressure (IOP)

  Baseline, Week 6, Week 12

• Overall Percent Change From Baseline in IOP

  Baseline, Week 6, Week 12

Other Outcomes (1)

• Change From Baseline in Hyperemia Severity in the Study Eye

  Baseline, Week 12

Study Arms (3)

Bimatoprost 0.01% (Naive Monotherapy)

EXPERIMENTAL

1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.

Drug: Bimatoprost 0.01%

Bimatoprost 0.01% (Switched Monotherapy)

EXPERIMENTAL

1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.

Drug: Bimatoprost 0.01%

Bimatoprost 0.01% (with Adjunctive Therapy)

EXPERIMENTAL

1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.

Drug: Bimatoprost 0.01%

Interventions

Bimatoprost 0.01% DRUG

1 drop in the affected eye(s), administered in the evening for 12 weeks.

Also known as: LUMIGAN® 0.01%

Bimatoprost 0.01% (Naive Monotherapy); Bimatoprost 0.01% (Switched Monotherapy); Bimatoprost 0.01% (with Adjunctive Therapy)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elevated IOP due to either primary open-angle glaucoma or ocular hypertension

You may not qualify if:

• None

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Seoul, South Korea

Location

Related Publications (1)

• Park KH, Simonyi S, Kim CY, Sohn YH, Kook MS. Bimatoprost 0.01% in treatment-naive patients with open-angle glaucoma or ocular hypertension: an observational study in the Korean clinical setting. BMC Ophthalmol. 2014 Dec 17;14:160. doi: 10.1186/1471-2415-14-160.

  PMID: 25519810 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Results Point of Contact

• Title: Vice President Medical Affairs,
• 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 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2012
• First Posted: May 9, 2012
• Study Start: March 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 28, 2014
• Results First Posted: January 28, 2014

Record last verified: 2014-01

Locations

KR (1)