A Study of Bimatoprost 0.01% in the Clinical Setting

NCT01814761 | Completed Results

• 1 other identifier: GMA-AP-EYE-AGN-001
• Study Type: observational
• Target: 312
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study of bimatoprost 0.01% (LUMIGAN® 0.01%) in subjects with primary open-angle glaucoma (POAG) or ocular hypertension (OH) who require further treatment for elevated intraocular pressure (IOP).

Conditions

Glaucoma, Primary 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 patients in each severity grade are presented.

  12 Weeks

Secondary Outcomes (3)

• Change From Baseline in Intraocular Pressure (IOP) in the Study Eye

  Baseline, Week 12

• Percentage of Patients Who Discontinue Due to an Adverse Event

  12 Weeks

• Overall Percent Change From Baseline in IOP

  Baseline, Week 12

Study Arms (2)

Pts with POAG or OH (Previously Treatment Naive)

Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).

Drug: Bimatoprost 0.01%

Pts with POAG or OH (Switched Monotherapy)

Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).

Drug: Bimatoprost 0.01%

Interventions

Bimatoprost 0.01% DRUG

One drop of bimatoprost 0.01% (Lumigan® 0.01%) in the affected eye(s) every evening for 12 weeks.

Also known as: Lumigan® 0.01%

Pts with POAG or OH (Previously Treatment Naive); Pts with POAG or OH (Switched Monotherapy)

Eligibility Criteria

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

Study Population

Subjects with primary open-angle glaucoma or ocular hypertension

You may qualify if:

• Diagnosis of primary open-angle glaucoma or ocular hypertension
• Determined by the treating physician to require treatment with bimatoprost 0.01%.

You may not qualify if:

• Previous use of Lumigan® 0.01%

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Taichung, Taiwan

Location

Related Publications (1)

• Chen YY, Wang TH, Liu C, Wu KY, Chiu SL, Simonyi S, Lu DW. Tolerability and efficacy of bimatoprost 0.01 % in patients with open-angle glaucoma or ocular hypertension evaluated in the Taiwanese clinical setting: the Asia Pacific Patterns from Early Access of Lumigan 0.01 % (APPEAL Taiwan) study. BMC Ophthalmol. 2016 Sep 15;16(1):162. doi: 10.1186/s12886-016-0338-6.

  PMID: 27633513 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: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2013
• First Posted: March 20, 2013
• Study Start: May 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: October 26, 2015
• Results First Posted: October 26, 2015

Record last verified: 2015-09

Locations

TW (1)