A Study of Patients With Primary Open Angle Glaucoma or Ocular Hypertension Switched to Lumigan® UD Monotherapy for Medical Reasons

NCT01853085 | Completed Results

• 1 other identifier: MAF/AGN/OPH/GLA/038
• Study Type: observational
• Target: 1,830
• Locations: 1 country
• Sites: 1

Brief Summary

The study will evaluate patients diagnosed with primary open angle glaucoma or ocular hypertension who are switched to Lumigan® UD monotherapy for medical reasons in accordance with physician standard clinical practice. All treatment decisions lie with the physician.

Conditions

Glaucoma, Primary Open Angle; Ocular Hypertension

Outcome Measures

Primary Outcomes (2)

• Intraocular Pressure (IOP) in the Study Eye at Baseline

  IOP is a measurement of the fluid pressure inside the study eye.

  Baseline

• IOP in the Study Eye at Week 12

  IOP is a measurement of the fluid pressure inside the study eye.

  Week 12

Secondary Outcomes (6)

• Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale

  Baseline, 12 Weeks

• Patient Assessment of Tolerability on a 4-Point Scale

  12 Weeks

• Physician Assessment of Tolerability on a 4-Point Scale

  12 Weeks

• Number of Patients Who Discontinue Treatment With Lumigan® UD Prior to 12 Weeks of Treatment

  12 Weeks

• Number of Patients Who Continue Treatment

  12 Weeks

Study Arms (1)

Patients with POAG or OHT

Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.

Drug: Bimatoprost Ophthalmic Solution

Interventions

Bimatoprost Ophthalmic Solution DRUG

Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.

Also known as: Lumigan® UD

Patients with POAG or OHT

Eligibility Criteria

• 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 primary open-angle glaucoma or ocular hypertension

You may qualify if:

• Diagnosed with primary open-angle glaucoma or ocular hypertension
• Previously prescribed intraocular pressure (IOP)-lowering medication with insufficient IOP control and is now being switched to Lumigan® UD for medical reasons

You may not qualify if:

• None

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Wiesloch, Baden-Wurttemberg, Germany

Location

Related Publications (1)

• Pillunat LE, Eschstruth P, Hasemeyer S, Thelen U, Foja C, Leaback R, Pfennigsdorf S. Preservative-free bimatoprost 0.03% in patients with primary open-angle glaucoma or ocular hypertension in clinical practice. Clin Ophthalmol. 2016 Sep 12;10:1759-65. doi: 10.2147/OPTH.S103084. eCollection 2016.

  PMID: 27672307 BACKGROUND

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: May 10, 2013
• First Posted: May 14, 2013
• Study Start: April 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 19, 2019
• Results First Posted: May 28, 2015

Record last verified: 2019-04

Locations

DE (1)