Eyedrop Instillation Technique

NCT01417689 | Unknown

• 1 other identifier: Oftalmo_Glaucoma_001
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma; Glaucoma Suspect

Keywords

glaucoma; randomized controlled trial; eye drops; instillation; compliance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Qualified success

  Day 1. Same day as intervention.

• Number of drops

  Day 1.

Study Arms (2)

Open-eyes

ACTIVE COMPARATOR

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

Closed-eyes

EXPERIMENTAL

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

Interventions

Encouragement to attempt eye drop instillation with a specific technique OTHER

Encouragement to one of the 2 techniques (open eyes and closed eyes) is accomplished through a standardized educational session designed to take2-5 minutes.

Closed-eyes; Open-eyes

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Oftalmologia Hospital Sotero del Rio: lead

Study Sites (1)

Hospital Sotero del Rio

Santiago, RM, 8207257, Chile

RECRUITING

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension; Patient Compliance

Condition Hierarchy (Ancestors)

Eye Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Eugenio A Maul, MD MPH

  Pontificia Universidad Catolica de Chile. Hospital Sotero del Rio.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Militza Sanchez, COT

CONTACT

+56982382507; militza_a@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 15, 2011
• First Posted: August 16, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: March 1, 2012
• Last Updated: August 16, 2011

Record last verified: 2011-08

Locations

CL (1)