Eye Drops Self-instillationPhase 4NCT01704248
The Effect of "Eye Drop Guide" on the Success Rate of Eye Drops Self-instillation in Glaucoma Patients
A Phase 4 study testing Eye Drop Guide technique and Routine self-instillation technique in people with Eye Drops Self-instillation, run by Mahidol University at 1 site in Thailand.
Trial summary
To investigate if the Eye Drop Guide more effective than carefully instructed routine technique for chronic glaucoma patients to self-instill eye drops. And what factors are associated with the failure of self-instillation eye drops with the Eye Drop Guide? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eye Drops Self-instillation
- What is being tested?
- Eye Drop Guide technique and Routine self-instillation technique
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2012to Apr 2013
- Phase
- Phase 4
- 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
- Have been diagnosed of chronic glaucoma for 3 months or longer
- Age of 18 years or over
- Self-administer eye drops regularly
Who cannot join
- Perioperative patients
- Patients who were blind from other diseases
- Patients with ophthalmic conditions that affect the eye drop instillation e.g. nystagmus, ptosis, exophthalmos, enophthalmos, microphthalmos, symblepharon, restrictive ophthalmoplegia
- Patients whose underlying conditions would affect the patient's adherence to the protocol e.g. dementia, psychosis, mental retardation, neurological conditions resulting in tremor or paralysis, rheumatoid arthritis, hand deformities
- Patients who are allergic to artificial tears eye drop
- Patients who are not able to return for the follow-up schedule
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, 10700
Darin Sakiyalak, MD, 6624198033-4, darin.sak@mahidol.ac.th
Darin Sakiyalak, MD
About this study
Official title: The Effect of "Eye Drop Guide" on the Success Rate of Eye Drops Self-instillation in Glaucoma Patients.
To investigate if the Eye Drop Guide more effective than carefully instructed routine technique for chronic glaucoma patients to self-instill eye drops.
And what factors are associated with the failure of self-instillation eye drops with the Eye Drop Guide?
Read the detailed description
The participants are randomized into 2 groups. For group I; the participants will be instructed to use the Eye Drop Guide first while for group II; the participants will be instructed to use the routine self-instillation technique first. The instruction will be given to all participants by the same investigator. The participants are allowed to practice until confidence in the techniques to which they are assigned. The participants then are instructed to use only that technique to instill eye drops in both eyes every day and keep the diary to document the date, time of practice, and number of bottles use in each eye for practice at home. The investigators make a telephone visit at 1 week to remind the practice routine and the follow up schedule. The 2 week follow up will be scheduled to evaluate the self-instillation performance using the techniques to which they are assigned by the VDO recordings under the same setting as Day 1.
After VDO recordings the participants will be switched to receive the other technique with the same instruction as the other group. Allow the same period of practice in the hospital and at home. The investigators again will make a 1-week telephone visit and 2-week follow up after self-practice at home. At week 4 the VDO recordings of self-instillation performance will be taken again under the same setting as previous records.
- Conditions
- Eye Drops Self-instillation
- Being tested
- Eye Drop Guide technique, Routine self-instillation technique
- Keywords
- eye drops self-instillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye Drop Guide techniqueDevice
- Wash the hands.
- Shake and then uncap the bottle.
- Hold the bottle between the thumb, index, and/or middle finger of the dominant hand.
- Use the lower lip of the cup to pull the lower lid down like what they normally do with the fingers.
- Then place the upper lip down to cover the whole orbital rim area.
- Tilt the head back if seated or standing.
- Insert the bottle in the device all the way. Hold the bottle gently.
- Look upward.
- Squeeze the bottle one drop at a time until feel one drop instilled into the eye.
- Close the eye 2-3 minutes.
For the non-seeing eye (best-corrected visual acuity ≤ 20/400) the participants should insert the bottle in the device before cover the eye then proceed with head tilt and look upward.
Routine self-instillation techniqueBehavioural
- Wash the hands.
- Shake and then uncap the bottle.
- Hold the bottle between the thumb, index, and/or middle finger of the dominant hand.
- Lie down or tilt the head back if seated or standing.
- Using the other hand, pull the lower lid down.
- Hold the bottle over the eye and look up.
- Squeeze the bottle one drop at a time until feel one drop instilled into the eye.
- Close the eye 2-3 minutes.
For the participants using more than one medication after instilling one bottle the participants should wait 3-5 minutes between administering different medications in the same eye.
| Study group | Role | What they receive |
|---|---|---|
| Routine self-instillation technique | Placebo comparator | The participants first use the Routine self-instillation technique for two weeks and then switch to the Eye Drop Guide technique for another two weeks. Receives: Device: Eye Drop Guide technique |
| Eye Drop Guide technique | Experimental | The participants first use the Eye Drop Guide technique for two weeks and then switch to the Routine self-instillation technique for another two weeks. Receives: Behavioral: Routine self-instillation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the success rate of self-instillation eye drops between carefully instructed routine technique and the use of Eye Drop Guide.
Measured: 1 month
Secondary outcomes (2)
1. To compare the total number of drops dispensed and time to instill drop between 2 groups.
Measured: 1 month
2. To identify the factors that associated with failure of using the Eye Drop Guide.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionFeb 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye Drops Self-instillationStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Darin Sakiyalak, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704248
- Sponsor's protocol ID
- 440/2555 (EC4)
- Status last verified
- Oct 2012
- First submitted
- 8 Oct 2012
- Last updated
- 11 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of "Eye Drop Guide" on the Success Rate of Eye Drops Self-instillation in Glaucoma Patients.
- ClinicalTrials.gov ID
- NCT01704248
- Acronym / sponsor ID
- 440/2555 (EC4)
- Conditions
- Eye Drops Self-instillation
- Keywords
- eye drops self-instillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 11 Oct 2012 (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.
To investigate if the Eye Drop Guide more effective than carefully instructed routine technique for chronic glaucoma patients to self-instill eye drops.
And what factors are associated with the failure of self-instillation eye drops with the Eye Drop Guide?
Detailed description
The participants are randomized into 2 groups. For group I; the participants will be instructed to use the Eye Drop Guide first while for group II; the participants will be instructed to use the routine self-instillation technique first. The instruction will be given to all participants by the same investigator. The participants are allowed to practice until confidence in the techniques to which they are assigned. The participants then are instructed to use only that technique to instill eye drops in both eyes every day and keep the diary to document the date, time of practice, and number of bottles use in each eye for practice at home. The investigators make a telephone visit at 1 week to remind the practice routine and the follow up schedule. The 2 week follow up will be scheduled to evaluate the self-instillation performance using the techniques to which they are assigned by the VDO recordings under the same setting as Day 1.
After VDO recordings the participants will be switched to receive the other technique with the same instruction as the other group. Allow the same period of practice in the hospital and at home. The investigators again will make a 1-week telephone visit and 2-week follow up after self-practice at home. At week 4 the VDO recordings of self-instillation performance will be taken again under the same setting as previous records.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine self-instillation technique | Placebo comparator | Device: Eye Drop Guide techniqueThe participants first use the Routine self-instillation technique for two weeks and then switch to the Eye Drop Guide technique for another two weeks. |
| Eye Drop Guide technique | Experimental | Behavioral: Routine self-instillation techniqueThe participants first use the Eye Drop Guide technique for two weeks and then switch to the Routine self-instillation technique for another two weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have been diagnosed of chronic glaucoma for 3 months or longer
- Age of 18 years or over
- Self-administer eye drops regularly
Key exclusion criteria (6 listed)
- Perioperative patients
- Patients who were blind from other diseases
- Patients with ophthalmic conditions that affect the eye drop instillation e.g. nystagmus, ptosis, exophthalmos, enophthalmos, microphthalmos, symblepharon, restrictive ophthalmoplegia
- Patients whose underlying conditions would affect the patient's adherence to the protocol e.g. dementia, psychosis, mental retardation, neurological conditions resulting in tremor or paralysis, rheumatoid arthritis, hand deformities
- Patients who are allergic to artificial tears eye drop
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 |
|---|---|---|
| Eye Drop Guide technique1. Wash the hands. 2. Shake and then uncap the bottle. 3. Hold the bottle between the thumb, index, and/or middle finger of the dominant hand. 4. Use the lower lip of the cup to pull the lower lid down like what they normally do with the fingers. 5. Then place the upper lip down to cover the whole orbital rim area. 6. Tilt the head back if seated or standing. 7. Insert the bottle in the device all the way. Hold the bottle gently. 8. Look upward. 9. Squeeze the bottle one drop at a time until feel one drop instilled into the eye. 10. Close the eye 2-3 minutes. For the non-seeing eye (best-corrected visual acuity ≤ 20/400) the participants should insert the bottle in the device before cover the eye then proceed with head tilt and look upward. | Device | Routine self-instillation technique |
| Routine self-instillation technique1. Wash the hands. 2. Shake and then uncap the bottle. 3. Hold the bottle between the thumb, index, and/or middle finger of the dominant hand. 4. Lie down or tilt the head back if seated or standing. 5. Using the other hand, pull the lower lid down. 6. Hold the bottle over the eye and look up. 7. Squeeze the bottle one drop at a time until feel one drop instilled into the eye. 8. Close the eye 2-3 minutes. For the participants using more than one medication after instilling one bottle the participants should wait 3-5 minutes between administering different medications in the same eye. | Behavioural | Eye Drop Guide technique |
Primary outcome
To compare the success rate of self-instillation eye drops between carefully instructed routine technique and the use of Eye Drop Guide.
Time frame: 1 month
2 secondary outcomes
1. To compare the total number of drops dispensed and time to instill drop between 2 groups.
Time frame: 1 month
2. To identify the factors that associated with failure of using the Eye Drop Guide.
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2012.
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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.
Darin Sakiyalak, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eye Drop Guide technique and Routine self-instillation technique in people with Eye Drops Self-instillation, run by Mahidol University at 1 site in Thailand.
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 6 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 11 Oct 2012. 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 Thailand. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Darin Sakiyalak, MD (66204198033-4, darin.sak@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the success rate of self-instillation eye drops between carefully instructed routine technique and the use of Eye Drop Guide. (time frame: 1 month). 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 11 Oct 2012.