Observational Study of Lumigan® 0.01% Treatment for Patients With Primary Open Angle Glaucoma or Ocular Hypertension

NCT01489670 | Completed Results

• 1 other identifier: MAF/AGN/OPH/GLA/032
• Study Type: observational
• Target: 387
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the efficacy, safety, tolerability and persistence of use of Lumigan ® 0.01% in patients diagnosed with primary open-angle glaucoma or ocular hypertension who are treated per routine clinical practice.

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 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 and right eye at the Final Visit at approximately Week 12. The lower the IOP values the greater the improvement.

  Week 12

Secondary Outcomes (5)

• Physician Evaluation of Efficacy Using a 5-Point Scale

  Week 12

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

  Week 12

• Physician Evaluation of Tolerability of Treatment

  Week 12

• Physician Reported Reasons for Early Discontinuation of Treatment

  12 Weeks

• Number of Patients Continuing Treatment After 12 Weeks

  Week 12

Study Arms (1)

Lumigan® 0.01%

Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.

Drug: bimatoprost 0.01% ophthalmic solution

Interventions

bimatoprost 0.01% ophthalmic solution DRUG

Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.

Also known as: Lumigan® 0.01%

Lumigan® 0.01%

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 diagnosed with primary open-angle glaucoma or ocular hypertension

You may qualify if:

• Diagnosis of primary open-angle glaucoma or ocular hypertension
• Lumigan® 0.01% prescribed either as monotherapy or adjunctive to beta-blocker therapy

You may not qualify if:

• None

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Bülach, Canton of Zurich, Switzerland

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: December 1, 2011
• First Posted: December 12, 2011
• Study Start: September 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 28, 2014
• Results First Posted: March 28, 2014

Record last verified: 2014-02

Locations

CH (1)