Adherence With Fixed Versus Unfixed Glaucoma Therapy

NCT ID: NCT01281020

Last Updated: 2020-12-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 132 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2011-07-31

Brief Summary

A 6-month, parallel, non-interventional trial investigating the level of adherence and the impact of dosing in open-angle glaucoma patients who receive either unfixed therapy with latanoprost once in the evening and timolol twice daily, or latanoprost/timolol fixed combination therapy once in the evening. All patients participating in this observational study will be monitored for their adherence with the use of Medication Event Monitoring System (MEMS). At the end of treatment periods treatment satisfaction will be assessed with selected questions from the Treatment Satisfaction Survey-Intraocular Pressure survey. This study will monitor objectively, for the first time, adherence and intraocular pressure control with fixed versus unfixed therapy. Finally it will help us to elucidate the impact of dosing (once-a-day versus three-times-daily) on the level of adherence in glaucoma.

Conditions

Primary Open-angle Glaucoma; Ocular Hypertension; Exfoliation Glaucoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Treatment with fixed combination

Patients who receive treatment with latanoprost/timolol fixed combination

No interventions assigned to this group

Treatment with unfixed therapy

Patients who receive latanoprost and timolol therapy

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patient is between 21-80 years old
• Patient has ocular hypertension or open-angle glaucoma Patient receives therapy and is well controlled on fixed or unfixed latanoprost and timolol therapy
• Untreated IOP >19 mm Hg <33 mm Hg at baseline (10:00 hour)
• Open normal appearing angles
• Patient had at least a 20% reduction vs untreated baseline on current therapy
• Patient has early or moderate glaucoma (< 14 decibel; 0.8 or better cupping)
• Distance best corrected Snellen visual acuity greater than 1/10

Exclusion Criteria

• Contraindication to timolol or prostaglandin therapy
• History of lack of response to any medication (< 10%)
• Patient does not understand the instructions and will not comply to medications
• Patient can not attend follow up
• Patient is a female of childbearing potential, or lactating mother
• History of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses
• Sign of ocular infection
• A corneal abnormality that may affect IOP measurements

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: lead

Responsible Party

AGP Konstas

Professor in Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anastasios G Konstas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Glaucoma Unit, 1st University Department of Ophthalmology

Locations

Glaucoma Unit, 1st University Department of Ophthalmology, AHEPA Hospital

Thessaloniki, , Greece

Countries

Greece

Other Identifiers

NIS50/01/08

Identifier Type: -

Identifier Source: org_study_id