Adherence With Fixed Versus Unfixed Glaucoma Therapy

NCT01281020 | Completed

• 1 other identifier: NIS50/01/08
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

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

Keywords

Glaucoma; Adherence; Fixed combination therapy

Outcome Measures

Primary Outcomes (1)

• Rate of adherence

  Rate of asherence with fixed vs unfixed glaucoma therapy

  6 months

Secondary Outcomes (2)

• Ocular surface evaluation

  6 months

• Treatment satisfaction

  6 months

Study Arms (2)

Treatment with fixed combination

Patients who receive treatment with latanoprost/timolol fixed combination

Treatment with unfixed therapy

Patients who receive latanoprost and timolol therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients who use latanoprost/timolol fixed combination therapy with once-a-day dosing in the evening All patients already treated with timolol twice daily and latanoprost once in the evening

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• Pfizer: collaborator

Study Sites (1)

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

Thessaloniki, 546 36, Greece

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Exfoliation Syndrome; Glaucoma

Condition Hierarchy (Ancestors)

Eye Diseases; Iris Diseases; Uveal Diseases

Study Officials

• Anastasios G Konstas, MD, PhD

  Glaucoma Unit, 1st University Department of Ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Ophthalmology

Study Record Dates

• First Submitted: January 20, 2011
• First Posted: January 21, 2011
• Study Start: May 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: December 17, 2020

Record last verified: 2020-12

Locations

GR (1)