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Eyedrop Instillation Technique

Primary Purpose

Glaucoma, Glaucoma Suspect

Status
Unknown status
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Encouragement to attempt eye drop instillation with a specific technique
Sponsored by
Oftalmologia Hospital Sotero del Rio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring glaucoma, randomized controlled trial, eye drops, instillation, compliance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Sotero del RioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Open-eyes

Closed-eyes

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 15, 2011
Last Updated
August 15, 2011
Sponsor
Oftalmologia Hospital Sotero del Rio
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1. Study Identification

Unique Protocol Identification Number
NCT01417689
Brief Title
Eyedrop Instillation Technique
Official Title
Eyedrop Instillation Technique: A Randomizaed Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
March 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Oftalmologia Hospital Sotero del Rio

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Glaucoma Suspect
Keywords
glaucoma, randomized controlled trial, eye drops, instillation, compliance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open-eyes
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Closed-eyes
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Encouragement to attempt eye drop instillation with a specific technique
Intervention Description
Encouragement to one of the 2 techniques (open eyes and closed eyes) is accomplished through a standardized educational session designed to take2-5 minutes.
Primary Outcome Measure Information:
Title
Complete success
Description
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.
Time Frame
Day 1. Immediately after intervention.
Secondary Outcome Measure Information:
Title
Qualified success
Description
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.
Time Frame
Day 1. Same day as intervention.
Title
Number of drops
Description
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.
Time Frame
Day 1.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Militza Sanchez, COT
Phone
+56982382507
Email
militza_a@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugenio A Maul, MD MPH
Organizational Affiliation
Pontificia Universidad Catolica de Chile. Hospital Sotero del Rio.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Sotero del Rio
City
Santiago
State/Province
RM
ZIP/Postal Code
8207257
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eugenio A Maul, MD MPH
Phone
+56966593935
Email
emaul@uc.cl
First Name & Middle Initial & Last Name & Degree
Eugenio A Maul, MD MPH

12. IPD Sharing Statement

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Eyedrop Instillation Technique

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