Eyedrop Instillation Technique
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Glaucoma Glaucoma Suspect |
Other: Encouragement to attempt eye drop instillation with a specific technique |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Eyedrop Instillation Technique: A Randomizaed Controlled Trial |
- Complete success [ Time Frame: Day 1. Immediately after intervention. ] [ Designated as safety issue: No ]
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.
- Qualified success [ Time Frame: Day 1. Same day as intervention. ] [ Designated as safety issue: No ]
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 [ Time Frame: Day 1. ] [ Designated as safety issue: No ]
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.
| Estimated Enrollment: | 230 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Militza Sanchez, COT | +56982382507 | militza_a@hotmail.com |
| Chile | |
| Hospital Sotero del Rio | Recruiting |
| Santiago, RM, Chile, 8207257 | |
| Contact: Eugenio A Maul, MD MPH +56966593935 emaul@uc.cl | |
| Principal Investigator: Eugenio A Maul, MD MPH | |
| Principal Investigator: | Eugenio A Maul, MD MPH | Pontificia Universidad Catolica de Chile. Hospital Sotero del Rio. |
More Information
No publications provided
| Responsible Party: | Eugenio A. Maul, 1 Pontificia Universidad Catolica de Chile, 2 Hospital Sotero del Rio. |
| ClinicalTrials.gov Identifier: | NCT01417689 History of Changes |
| Other Study ID Numbers: | Oftalmo_Glaucoma_001 |
| Study First Received: | August 15, 2011 |
| Last Updated: | August 15, 2011 |
| Health Authority: | Chile: Comite de Etica Hospital Sotero del Rio |
Keywords provided by Oftalmologia Hospital Sotero del Rio:
|
glaucoma randomized controlled trial eye drops instillation compliance |
Additional relevant MeSH terms:
|
Glaucoma Ocular Hypertension Eye Diseases Tetrahydrozoline Nasal Decongestants Vasoconstrictor Agents Cardiovascular Agents |
Therapeutic Uses Pharmacologic Actions Respiratory System Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013