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Eyedrop Instillation Technique

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ClinicalTrials.gov Identifier: NCT01417689
Recruitment Status : Unknown
Verified August 2011 by Oftalmologia Hospital Sotero del Rio.
Recruitment status was:  Recruiting
First Posted : August 16, 2011
Last Update Posted : August 16, 2011
Sponsor:
Information provided by:
Oftalmologia Hospital Sotero del Rio

Tracking Information
First Submitted Date  ICMJE August 15, 2011
First Posted Date  ICMJE August 16, 2011
Last Update Posted Date August 16, 2011
Study Start Date  ICMJE August 2011
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2011)
Complete success [ Time Frame: Day 1. Immediately after intervention. ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2011)
  • Qualified success [ Time Frame: Day 1. Same day as intervention. ]
    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. ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Eyedrop Instillation Technique
Official Title  ICMJE Eyedrop Instillation Technique: A Randomizaed Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Glaucoma
  • Glaucoma Suspect
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 15, 2011)
230
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2012
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01417689
Other Study ID Numbers  ICMJE Oftalmo_Glaucoma_001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eugenio A. Maul, 1 Pontificia Universidad Catolica de Chile, 2 Hospital Sotero del Rio.
Study Sponsor  ICMJE Oftalmologia Hospital Sotero del Rio
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eugenio A Maul, MD MPH Pontificia Universidad Catolica de Chile. Hospital Sotero del Rio.
PRS Account Oftalmologia Hospital Sotero del Rio
Verification Date August 2011

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