Evaluation of a New Method for Instilling Eye Drops

NCT02697318 | Completed Early Phase 1

• 1 other identifier: 21282
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to demonstrate that there is a new easier method to instill eye drops in ones own eye that is as effective as applying a drop directly to their open eye. The benefits of this new method include better medication compliance and reduced patient anxiety from instilling their eye drops. This secondary benefit should remove the "approach-avoidance response" that prompts some patients to delay or give-up on instilling their drops just to avoid the angst and frustration produced by the challenge. The new method involves the patient instilling the eye drop onto their closed eyelid and then blinking the eye drop into their eye. We aim to show that this method has a similar therapeutic effect as the routine administration of an eye drop to an open eye.

Conditions

Ophthalmic Solutions; Glaucoma

Outcome Measures

Primary Outcomes (1)

• Intraocular Pressure

  Intraocular Pressure by Goldmann applanation will be measured pre- and 2 hours post timolol maleate 0.5% ophthalmic solution

  2 hours

Study Arms (2)

Professional Administration

OTHER

Instillation of Timolol maleate 0.5% ophthalmic solution (or participant's own glaucoma medication) administered by a professional, using the standard clinical method.

Drug: Timolol maleate 0.5% ophthalmic solution

Self-Administration (new method)

OTHER

Instillation of Timolol maleate 0.5% ophthalmic solution (or participant's own glaucoma medication) self-administered by the participant, using the new proposed method.

Drug: Timolol maleate 0.5% ophthalmic solution

Interventions

Timolol maleate 0.5% ophthalmic solution DRUG

Professional Administration; Self-Administration (new method)

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• both male and female participants are being studied
• minimum age of 21 and maximum age of 80
• healthy volunteers with no previous history of eye disease

You may not qualify if:

• no medical conditions representing contraindications to use of topical beta-blocker.
• subject must not have any active inflammatory diseases of the eye, or have a diagnosis of any form of glaucoma
• Aim #2:
• both male and female participants are being studied
• minimum age of 21 and maximum age of 80
• subjects have been diagnosed with primary open angle glaucoma and are stable on monotherapy
• \- Subjects must have no other ocular disease, or a history of prior ocular trauma, beyond minor corneal abrasion or removal of a superficial corneal foreign body.

Sponsors & Collaborators

• University of Waterloo: lead

Study Sites (1)

University of Waterloo

Waterloo, Ontario, N2L3G1, Canada

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Timolol; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: March 3, 2016
• Study Start: May 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: January 7, 2018
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

CA (1)