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Effects of Prostaglandin Analogue Washout Following Long-term Therapy in Adults With Primary Open Angle Glaucoma

NCT03534882 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2019-04-11

No results posted yet for this study

Summary

A target for glaucoma treatment is the intra-ocular pressure (IOP) which is lowered with medications, laser, or surgical intervention. The efficacy of different medication classes is well understood as their IOP lowering effects have been well documented. However, beyond the basic biochemical and pharmacokinetic actions, long-term effects of these drugs on IOP have not been adequately studied. Specifically, does long-term use of anti-glaucoma medications have lasting effects on IOP even with subsequent discontinuation of the medication? In Ontario, prostaglandin analogues are the most frequently prescribed first line anti-glaucoma medication. In our study, we examine the lingering IOP-reducing effects of the prostaglandin analogue anti-glaucoma drug class. Our overall objective is to determine if patients previously treated with prostaglandin analogues remain within acceptable treatment ranges 6 weeks after medication discontinuation, and if this IOP differs from pre-treatment baseline values. Half of participants will discontinue their prostaglandin analogue (PGA) treatment for 6 weeks, while the other half will continue their PGA therapy as prescribed by their ophthalmologist. Both groups will be followed closely throughout the 6 weeks to monitor changes in IOP. This can help us understand the lasting effects of medication use and can help better guide clinical care in optimizing glaucoma management, and help direct study designs of future research that involve any therapy secondary to prostaglandin analogue treatment.

Conditions

Interventions

OTHER

Discontinuation of topical prostaglandin analogue therapy

Participants are asked to discontinue their prostaglandin analogue eye drops for the designated time period (42 days)

Sponsors & Collaborators

  • Cindy Hutnik

    lead OTHER

Principal Investigators

  • Cindy ML Hutnik, MD, PhD · Western University, Department of Ophthalmology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-27
Primary Completion
2017-06-22
Completion
2017-06-22

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03534882 on ClinicalTrials.gov