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
  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

Resource links provided by NLM:


Further study details as provided by Oftalmologia Hospital Sotero del Rio:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01417689

Contacts
Contact: Militza Sanchez, COT +56982382507 militza_a@hotmail.com

Locations
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         
Sponsors and Collaborators
Oftalmologia Hospital Sotero del Rio
Investigators
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
Ophthalmic Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 22, 2014