Observational Study of Lumigan® 0.01% for Treatment of Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

NCT01568008 | Completed Results

• 1 other identifier: MAF/AGN/OPH/GLA/031
• Study Type: observational
• Target: 933
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational study in patients with POAG or OHT that will collect data on the use of Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) in a routine clinical setting. Patients will be seen at baseline and at a follow-up visit approximately 8-12 weeks after baseline, as per normal clinical practice.

Conditions

Open-Angle Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (2)

• Intraocular Pressure (IOP) at Baseline

  IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eye at Baseline.

  Baseline

• Intraocular Pressure (IOP) at Week 12

  IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left eye and the right eye at Week 12. The lower the IOP values the greater the improvement.

  Week 12

Secondary Outcomes (4)

• Patient Assessment of Treatment Tolerability Using a 4-Point Scale

  12 weeks

• Physician Assessment of Treatment Tolerability Using a 4-Point Scale

  12 weeks

• Physician Reported Reasons for Treatment Discontinuation

  12 weeks

• Number of Patients Continuing Treatment After 12 Weeks

  12 weeks

Study Arms (1)

All participants

Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.

Drug: Bimatoprost 0.01% ophthalmic solution

Interventions

Bimatoprost 0.01% ophthalmic solution DRUG

Bimatoprost 0.01% ophthalmic solution eye drops at a dose and frequency as determined by the physician.

Also known as: Lumigan®

All participants

Eligibility Criteria

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

Study Population

Patients with POAG or OHT

You may qualify if:

• Diagnosis of POAG or OHT
• Prescribed Lumigan® 0.01%

You may not qualify if:

• None

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Ghent, Oost-Vlaanderen, Belgium

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Bimatoprost; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Glaucoma; 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: 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: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: April 2, 2012
• Study Start: October 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: September 20, 2013
• Results First Posted: September 20, 2013

Record last verified: 2013-07

Locations

BE (1)