Eyedrop Instillation Technique

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Oftalmologia Hospital Sotero del Rio.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Oftalmologia Hospital Sotero del Rio
ClinicalTrials.gov Identifier:
NCT01417689
First received: August 15, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted

August 15, 2011
August 15, 2011
August 2011
December 2011   (final data collection date for primary outcome measure)
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.

Same as current
No Changes Posted
  • 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.

Same as current
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Glaucoma
  • Glaucoma Suspect
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.
  • 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.
    Intervention: Other: Encouragement to attempt eye drop instillation with a specific technique
  • 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.
    Intervention: Other: Encouragement to attempt eye drop instillation with a specific technique
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
230
March 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Militza Sanchez, COT +56982382507 militza_a@hotmail.com
Chile
 
NCT01417689
Oftalmo_Glaucoma_001
No
Eugenio A. Maul, 1 Pontificia Universidad Catolica de Chile, 2 Hospital Sotero del Rio.
Oftalmologia Hospital Sotero del Rio
Not Provided
Principal Investigator: Eugenio A Maul, MD MPH Pontificia Universidad Catolica de Chile. Hospital Sotero del Rio.
Oftalmologia Hospital Sotero del Rio
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP