A Study of Lumigan® 0.01% in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

NCT01589510 | Completed Results

• 1 other identifier: MAF/AGN/OPH/GLA/034
• Study Type: observational
• Target: 419
• Locations: 1 country
• Sites: 1

Brief Summary

A study of Lumigan® 0.01% as administered in standard practice for patients with POAG or OHT. All treatment decisions, care and diagnostic procedures provided are at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.

Conditions

Glaucoma, Open-Angle; 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 eyes at Baseline.

  Baseline

• IOP at Week 14

  IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 14.

  Week 14

Secondary Outcomes (6)

• Physician Evaluation of IOP Lowering in the Study Eye(s)

  Week 14

• Patient Assessment of Tolerability on a 4-Point Scale

  Week 14

• Physician Assessment of Tolerability on a 4-Point Scale

  Week 14

• Percentage of Patients Who Discontinue Lumigan® 0.01% Prior to 14 Weeks of Treatment

  14 Weeks

• Percentage of Patients Who Continue Lumigan® 0.01% Treatment

  Week 14

Study Arms (1)

Lumigan® 0.01%

Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.

Drug: bimatoprost 0.01% ophthalmic solution

Interventions

bimatoprost 0.01% ophthalmic solution DRUG

Bimatoprost 0.01% ophthalmic solution (Lumigan® 0.01%) as prescribed by physician per standard practice for up to 14 weeks.

Also known as: Lumigan® 0.01%

Lumigan® 0.01%

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with POAG and 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

Vienna, Austria

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: April 30, 2012
• First Posted: May 2, 2012
• Study Start: April 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: June 13, 2014
• Results First Posted: June 13, 2014

Record last verified: 2014-05

Locations

AU (1)