A Study of Patients With Primary Open Angle Glaucoma or Ocular Hypertension Who Were Insufficiently Responsive to Monotherapy

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01637246
• Other study ID #: MAF/AGN/OPH/GLA/017
• Secondary ID: AGN-EPI-2009-02
• Status: Completed
• Phase: N/A
• First received: July 9, 2012
• Last updated: August 21, 2012
• Start date: April 2009
• Est. completion date: November 2011

Study information

• Verified date: August 2012
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial Summary

This is a retrospective chart review and will assess changes in IOP after treatment with any fixed combination in patients who previously received monotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4385
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosis of glaucoma or ocular hypertension

• Previously treated with monotherapy followed by fixed combination therapy for at least 12 weeks

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• Any Fixed Combination Therapy
Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy. This was a retrospective chart review study, so no treatment was administered in this study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Intraocular Pressure (IOP)	IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.	Baseline, 12 Weeks	No
Secondary	Patient Assessment of Tolerability Using a 4-Point Scale	Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The percentage of patients assessed as good and very good combined are reported.	12 Weeks	No
Secondary	Physician Assessment of Tolerability Using a 4-Point Scale	Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The percentage of patients assessed as good and very good combined are reported.	12 Weeks	No
Secondary	Percentage of Patients Who Maintained Better Compliance With Treatment	Percentage of patients who maintained better compliance with treatment than prior therapy was assessed by the patient on a 3-point scale (better, equal, and worse compliance).	12 Weeks	No
Secondary	Percentage of Patients Continuing on Therapy After 12 Weeks	Percentage of patients continuing on therapy after 12 weeks was assessed as Yes or No.	12 Weeks	No