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

NCT03534882 | Completed

• 1 other identifier: 4834
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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

Primary Open-Angle Glaucoma, Mild Stage; Glaucoma, Suspect; Ocular Hypertension

Keywords

anti-glaucoma medications; glaucoma; prostaglandin analogues; medication washout

Outcome Measures

Primary Outcomes (1)

• Day 42 Intraocular Pressure (mmHg)

  Measured by Goldmann Applanation Tonometer

  42 days after starting trial

Secondary Outcomes (2)

• Day 7 Intraocular Pressure (mmHg)

  7 days after starting trial

• Day 21 Intraocular Pressure (mmHg)

  21 days after starting trial

Study Arms (2)

Washout

EXPERIMENTAL

Discontinuation of topical prostaglandin analogue therapy: Participants are asked to discontinue (washout) their prostaglandin analogue for 42 days. As the experimental group, the purpose of this arm is to determine the lingering IOP-reducing effects following discontinuation of chronic prostaglandin analogue therapy, and to determine if IOP rises back to baseline (pre-treatment values).

Other: Discontinuation of topical prostaglandin analogue therapy

Control

NO INTERVENTION

Patients are asked to remain on their prostaglandin analogues and continue treatment as prescribed by their ophthalmologist. The purpose of this arm is to minimize bias in intraocular pressure readings.

Interventions

Discontinuation of topical prostaglandin analogue therapy OTHER

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

Also known as: Medication washout

Washout

Eligibility Criteria

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

You may qualify if:

• Diagnosis of glaucoma or or ocular hypertension
• Prostaglandin analogue responder \>20% intraocular pressure (IOP) reduction from baseline
• Age \>18 years
• Baseline IOP (pre-treatment) ≥21 mmHg
• Prostaglandin analogue treatment duration \> 6 months

You may not qualify if:

• Diagnosis of acute angle closure glaucoma
• Treatment with \> 1 glaucoma medication
• Topical steroid \> 3 consecutive weeks
• Intraocular surgery in last 6 months prior to enrollment
• Glaucoma laser intervention in last 12 months prior to enrollment
• Best Corrected Visual Acuity (BCVA) \< 70 letters (EDTRS or Snellen equivalent)
• Visual field mean deviation \<-3

Sponsors & Collaborators

• Cindy Hutnik: lead

Study Sites (1)

Ivey Eye Institute

London, Ontario, N6A 4V2, Canada

Location

Related Publications (5)

• Kass MA, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish RK 2nd, Wilson MR, Gordon MO. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002 Jun;120(6):701-13; discussion 829-30. doi: 10.1001/archopht.120.6.701.

  PMID: 12049574 BACKGROUND

• Tataru CP, Purcarea VL. Antiglaucoma pharmacotherapy. J Med Life. 2012 Sep 15;5(3):247-51. Epub 2012 Sep 25.

  PMID: 23049625 BACKGROUND

• Lee R, Hutnik CM. Projected cost comparison of selective laser trabeculoplasty versus glaucoma medication in the Ontario Health Insurance Plan. Can J Ophthalmol. 2006 Aug;41(4):449-56. doi: 10.1016/S0008-4182(06)80006-2.

  PMID: 16883360 BACKGROUND

• Kreidler SM, Muller KE, Grunwald GK, Ringham BM, Coker-Dukowitz ZT, Sakhadeo UR, Baron AE, Glueck DH. GLIMMPSE: Online Power Computation for Linear Models with and without a Baseline Covariate. J Stat Softw. 2013 Sep;54(10):i10. doi: 10.18637/jss.v054.i10.

  PMID: 24403868 BACKGROUND

• Lim CW, Diaconita V, Liu E, Ault N, Lizotte D, Nguyen M, Hutnik CML. Effect of 6-week washout period on intraocular pressure following chronic prostaglandin analogue treatment: a randomized controlled trial. Can J Ophthalmol. 2020 Apr;55(2):143-151. doi: 10.1016/j.jcjo.2019.08.004. Epub 2019 Nov 8.

  PMID: 31712013 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Cindy ML Hutnik, MD, PhD

  Western University, Department of Ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ophthalmology, Glaucoma Specialist

Model Details: This randomized-controlled trial studies patients with primary open angle glaucoma or ocular hypertension currently treated with topical IOP-lowering prostaglandin analogue (PGA) medications. Patients meeting inclusion criteria and having none of the exclusion criteria are contacted. If interested, patients meet research staff to discuss the study protocol and informed consent is obtained. Participants are randomized to one of two groups (A or B). Allocation to group is concealed to physicians. Participants have their IOP measured at Day 0. Group A patients are asked to discontinue their PGA for 42 days. Group B patients continue their medications as prescribed by their physician. Patients are closely followed, where IOP is measured on day 7, 21, and 42 in all participants. Once the assessment is complete, participants are debriefed on the nature of the study and potential findings. At the end of trial, participants resume standard therapy according to CJO 2009 Glaucoma Guidelines.

Study Record Dates

• First Submitted: May 11, 2018
• First Posted: May 23, 2018
• Study Start: May 27, 2014
• Primary Completion: June 22, 2017
• Study Completion: June 22, 2017
• Last Updated: April 11, 2019

Record last verified: 2019-04

Locations

CA (1)