GlaucomaNCT01417689
Eyedrop Instillation Technique
A study testing Encouragement to attempt eye drop instillation with a specific technique in people with Glaucoma and Glaucoma Suspect, run by Oftalmologia Hospital Sotero del Rio at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Glaucoma Suspect
- What is being tested?
- Encouragement to attempt eye drop instillation with a specific technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteChile
- Study dates
- Aug 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous history of allergy to fluorescein
- Received topical anesthesia for IOP measurement or other reason within the last 2 hours.
- Rejects participation
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Hospital Sotero del Rio
Santiago, RM, 8207257
Eugenio A Maul, MD MPH, +56966593935, emaul@uc.cl
Eugenio A Maul, MD MPH
About this study
Official title: 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.
Read more
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
- Being tested
- Encouragement to attempt eye drop instillation with a specific technique
- Keywords
- glaucoma, randomized controlled trial, eye drops, instillation, compliance
- Medical subject headings
- Glaucoma, Ocular Hypertension, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Encouragement to attempt eye drop instillation with a specific techniqueOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Encouragement to attempt eye drop instillation with a specific technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1. Immediately after intervention.
Secondary outcomes (2)
Qualified success
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.
Measured: Day 1. Same day as intervention.
Number of drops
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.
Measured: Day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2011 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oftalmologia Hospital Sotero del Rio
- Sponsor type
- University, hospital or other
- Investigators
- Eugenio A Maul, MD MPH, Principal investigator, Pontificia Universidad Catolica de Chile. Hospital Sotero del Rio.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01417689
- Sponsor's protocol ID
- Oftalmo_Glaucoma_001
- Status last verified
- Aug 2011
- First submitted
- 15 Aug 2011
- Last updated
- 16 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eyedrop Instillation Technique: A Randomizaed Controlled Trial
- ClinicalTrials.gov ID
- NCT01417689
- Acronym / sponsor ID
- Oftalmo_Glaucoma_001
- Conditions
- Glaucoma, Glaucoma Suspect
- Keywords
- glaucoma, randomized controlled trial, eye drops, instillation, compliance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Oftalmologia Hospital Sotero del RioUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 16 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open-eyes | Active comparator | Other: Encouragement to attempt eye drop instillation with a specific techniquePatients 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. |
| Closed-eyes | Experimental | Other: Encouragement to attempt eye drop instillation with a specific techniquePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Previous history of allergy to fluorescein
- Received topical anesthesia for IOP measurement or other reason within the last 2 hours.
- Rejects participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Encouragement to attempt eye drop instillation with a specific techniqueEncouragement to one of the 2 techniques (open eyes and closed eyes) is accomplished through a standardized educational session designed to take2-5 minutes. | Other | Closed-eyes, Open-eyes |
Primary outcome
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.
2 secondary outcomes
Qualified success
Time frame: Day 1. Same day as intervention.
Number of drops
Time frame: Day 1.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugenio A Maul, MD MPH principal investigator
Pontificia Universidad Catolica de Chile. Hospital Sotero del Rio.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Encouragement to attempt eye drop instillation with a specific technique in people with Glaucoma and Glaucoma Suspect, run by Oftalmologia Hospital Sotero del Rio at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Militza Sanchez, COT (+56982382507, militza_a@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete success (time frame: Day 1. Immediately after intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2011.