Eyedrop Instillation Technique

Eyedrop Instillation Technique: A Randomizaed Controlled Trial

Eye drop instillation is a problem from glaucoma patients. Studies reveal that 30-50% of glaucoma patients have problems instilling their eyedrops. These problems include not hitting the eye, spending many drops to get a single successful instillation and bottle contamination.

The present study will evaluate the effect of encouraging patients to put their eyedrops using one of 2 techniques, randomly assigned, to determine which is more successful at instilling the eye drop into the eye while spending the least amount of drug.

In one of the techniques the patient instills the eye drop with their eyes open in the inferior cul de sac. In the other technique the patient instills the eye drop with the eyes closed near the inner canthal region.

Patients will be randomized to encouragement to use the drops with either of the techniques. Encouragement will take place over a visit where they will be subjected to:

• Baseline evaluation of eye drop instillation using their usual technique.
• Short (2-5 minute) educational session session for the assigned technique.
• Followup evaluation immediately after the educational session.

Study Overview

• Status: Unknown
• Conditions: Glaucoma; Glaucoma Suspect
• Intervention / Treatment: Other: Encouragement to attempt eye drop instillation with a specific technique

• Study Type: Interventional
• Enrollment (Anticipated): 230
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • RM
    • Santiago, RM, Chile, 8207257
      • Recruiting
      • Hospital Sotero Del Rio
      • Contact: Eugenio A Maul, MD MPH; Phone Number: +56966593935; Email: emaul@uc.cl
      • Principal Investigator: Eugenio A Maul, MD MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Glaucoma or glaucoma suspect
• Use of topical glaucoma medication in both eyes for at least 1 year prior to enrollment
• VA of 20/60 or better with habitual correction in at least one eye

Exclusion Criteria:

• Previous history of allergy to fluorescein
• Received topical anesthesia for IOP measurement or other reason within the last 2 hours.
• Rejects participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Open-eyes; Patients in this arm are encourage to attempt eye drop instillation using the most commonly used technique that involves looking up, pulling inferior lid down and putting the drop in the inferior cul de sac.	Other: Encouragement to attempt eye drop instillation with a specific technique; Encouragement to one of the 2 techniques (open eyes and closed eyes) is accomplished through a standardized educational session designed to take2-5 minutes.
Experimental: Closed-eyes; Patients in this group are encouraged to attempt eye drop instillation with both eyes closed near the medial canthal region. After feeling contact with the drop on the skin the drop is expected to enter the eye when opening the eye and resuming blinking.	Other: Encouragement to attempt eye drop instillation with a specific technique; Encouragement to one of the 2 techniques (open eyes and closed eyes) is accomplished through a standardized educational session designed to take2-5 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete success	Total success is defined as: Patient manages to instill one eyedrop into de eye spending only one eye drop. Difference in the proportion of patients achieving successful eye drop instillation in each of the 2 groups. For the main analysis the results of the first eye (Right or left randomly determined will be used) A mixed model with both eyes in the analysis will also be presented for sensitivity analysis.	Day 1. Immediately after intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualified success	Qualified success is defined as: Patient manages to instill one eye drop into the eye regardless of the amount of drops spent. Difference in the proportion of patients achieving successful eye drop instillation in each of the 2 groups. For the main analysis the results of the first eye (Right or left randomly determined will be used) A mixed model with both eyes in the analysis will also be presented for sensitivity analysis.	Day 1. Same day as intervention.
Number of drops	Number of eye drops spent on attempted instillation in the first eye (randomly assigned). The average number of drops spent on each of the groups will be compared. Mixed models with data from both eyes will also be presented for sensitivity analysis.	Day 1.

Collaborators and Investigators

• Sponsor: Oftalmologia Hospital Sotero del Rio
• Investigators: Principal Investigator: Eugenio A Maul, MD MPH, Pontificia Universidad Catolica de Chile. Hospital Sotero del Rio.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): March 1, 2012

Study Registration Dates

• First Submitted: August 15, 2011
• First Submitted That Met QC Criteria: August 15, 2011
• First Posted (Estimate): August 16, 2011

Study Record Updates

• Last Update Posted (Estimate): August 16, 2011
• Last Update Submitted That Met QC Criteria: August 15, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: randomized controlled trial; compliance; glaucoma; eye drops; instillation
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: Oftalmo_Glaucoma_001