Eyedrop Instillation Technique

Glaucoma Clinical Trial

Official title:

Eyedrop Instillation Technique: A Randomizaed Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01417689
• Other study ID #: Oftalmo_Glaucoma_001
• Status: Recruiting
• Phase: N/A
• First received: August 15, 2011
• Last updated: August 15, 2011
• Start date: August 2011
• Est. completion date: March 2012

Study information

• Verified date: August 2011
• Source: Oftalmologia Hospital Sotero del Rio
• Contact: Militza Sanchez, COT
• Phone: +56982382507
• Email: militza_a[@]hotmail.com
• Is FDA regulated: No
• Health authority: Chile: Comite de Etica Hospital Sotero del Rio
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma Suspect

Intervention

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.

Locations

Country	Name	City	State
Chile	Hospital Sotero del Rio	Santiago	RM

Sponsors (1)

Lead Sponsor	Collaborator
Oftalmologia Hospital Sotero del Rio

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	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.	No