Ophthalmic SolutionsEarly Phase 1NCT02697318
Evaluation of a New Method for Instilling Eye Drops
A Early Phase 1 study testing Timolol maleate 0.5% ophthalmic solution in people with Ophthalmic Solutions and Glaucoma, run by University of Waterloo at 1 site in Canada.
Trial summary
The purpose of this project is to demonstrate that there is a new easier method to instill eye drops in ones own eye that is as effective as applying a drop directly to their open eye. The benefits of this new method include better medication compliance and reduced patient anxiety from instilling their eye drops. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Ophthalmic Solutions, Glaucoma
- What is being tested?
- Timolol maleate 0.5% ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- May 2016to 7 Jan 2018
- Phase
- Early Phase 1
- 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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- both male and female participants are being studied
- minimum age of 21 and maximum age of 80
- healthy volunteers with no previous history of eye disease
- both male and female participants are being studied
- minimum age of 21 and maximum age of 80
- subjects have been diagnosed with primary open angle glaucoma and are stable on monotherapy
Who cannot join
- no medical conditions representing contraindications to use of topical beta-blocker.
- subject must not have any active inflammatory diseases of the eye, or have a diagnosis of any form of glaucoma
- Aim #2:
- Subjects must have no other ocular disease, or a history of prior ocular trauma, beyond minor corneal abrasion or removal of a superficial corneal foreign body.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this project is to demonstrate that there is a new easier method to instill eye drops in ones own eye that is as effective as applying a drop directly to their open eye. The benefits of this new method include better medication compliance and reduced patient anxiety from instilling their eye drops. This secondary benefit should remove the "approach-avoidance response" that prompts some patients to delay or give-up on instilling their drops just to avoid the angst and frustration produced by the challenge.
The new method involves the patient instilling the eye drop onto their closed eyelid and then blinking the eye drop into their eye. We aim to show that this method has a similar therapeutic effect as the routine administration of an eye drop to an open eye.
Read the detailed description
PURPOSE:
The purpose of this project is to test an alternative method for instilling eye drops. The new method involves the patient self-administer the eye drop onto the skin of their medial canthus, with the lids gently closed, and then open the lids once the "cold and wet" sensation of the eye drop is felt along the margins of the closed lids. We will compare the physiological and therapeutic efficacy of instilling the same eye drops into the eyes of the same subjects, using two methods. The first will be to have the eye drop administered using the "gold standard" method employed by optometrists to instill eye drops in the office. The second will be to employ the new method of self-administration described above.
HYPOTHESIS:
Instillation of an eye drop, over the gently closed lids at the medial canthus, has the same physiological effect and therapeutic efficacy as a drop of the same agent, at the same concentration, properly applied onto an open eye by a trained professional.
Aim #1: Determine if there is a difference in efficacy between drops of 0.5% timolol maleate administered by a professional, using the standard clinical method versus patient self-administration using the newly proposed method, in NORMAL SUBJECTS.
Aim #2: Determine if there is a difference in efficacy between glaucoma drops administered by a professional, using the standard method versus with patient self-administration of the same drop, using the newly proposed method, in GLAUCOMA PATIENTS.
JUSTIFICATION:
While new drug development in the glaucoma field seeks to address the issue of the difficulty patients experience with self-administration of an eye drop by pressing for new drugs that show efficacy in a once daily dosing routine, this strategy has potentially serious negative consequences. Clearly, when glaucoma medications are administered only once a day, if the patient misses their eye on that single instillation, the period of lapsed treatment is 24 hours or more. If their disease worsens, either due to non-compliance with their treatment regimen or inability to instill an eye drop, they will require more follow up visits, additional medications, additional diagnostic tests, and earlier surgery.
In this regard, the consequences of non-compliance or inability to comply are the same - increased blindness from glaucoma and increased costs associated with trying to prevent this blindness in needlessly advancing disease.
OBJECTIVES:
The objective of this proposal is to test the therapeutic efficacy of an alternative method of instilling eye drops. This requires comparing the effects of the same volume of the same drug, applied using the classical method and the new alternative method. If the proposed study is successful, a more reliable method for instilling drops of all kinds, to all patients, will have been validated.
- Conditions
- Ophthalmic Solutions, Glaucoma
- Being tested
- Timolol maleate 0.5% ophthalmic solution
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timolol maleate 0.5% ophthalmic solutionDrug
| Study group | Role | What they receive |
|---|---|---|
| Professional Administration | Other | Instillation of Timolol maleate 0.5% ophthalmic solution (or participant's own glaucoma medication) administered by a professional, using the standard clinical method. Receives: Drug: Timolol maleate 0.5% ophthalmic solution |
| Self-Administration (new method) | Other | Instillation of Timolol maleate 0.5% ophthalmic solution (or participant's own glaucoma medication) self-administered by the participant, using the new proposed method. Receives: Drug: Timolol maleate 0.5% ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure
Intraocular Pressure by Goldmann applanation will be measured pre- and 2 hours post timolol maleate 0.5% ophthalmic solution
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startMay 2016
- Primary completionSep 2017
- Study completion7 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ophthalmic SolutionsStudies 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697318
- Sponsor's protocol ID
- 21282
- Status last verified
- Jan 2018
- First submitted
- 29 Feb 2016
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Method for Instilling Eye Drops
- ClinicalTrials.gov ID
- NCT02697318
- Acronym / sponsor ID
- 21282
- Conditions
- Ophthalmic Solutions, Glaucoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- 7 Jan 2018 (actual)
- First posted
- 3 Mar 2016 (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.
The purpose of this project is to demonstrate that there is a new easier method to instill eye drops in ones own eye that is as effective as applying a drop directly to their open eye. The benefits of this new method include better medication compliance and reduced patient anxiety from instilling their eye drops. This secondary benefit should remove the "approach-avoidance response" that prompts some patients to delay or give-up on instilling their drops just to avoid the angst and frustration produced by the challenge.
The new method involves the patient instilling the eye drop onto their closed eyelid and then blinking the eye drop into their eye. We aim to show that this method has a similar therapeutic effect as the routine administration of an eye drop to an open eye.
Detailed description
PURPOSE:
The purpose of this project is to test an alternative method for instilling eye drops. The new method involves the patient self-administer the eye drop onto the skin of their medial canthus, with the lids gently closed, and then open the lids once the "cold and wet" sensation of the eye drop is felt along the margins of the closed lids. We will compare the physiological and therapeutic efficacy of instilling the same eye drops into the eyes of the same subjects, using two methods. The first will be to have the eye drop administered using the "gold standard" method employed by optometrists to instill eye drops in the office. The second will be to employ the new method of self-administration described above.
HYPOTHESIS:
Instillation of an eye drop, over the gently closed lids at the medial canthus, has the same physiological effect and therapeutic efficacy as a drop of the same agent, at the same concentration, properly applied onto an open eye by a trained professional.
Aim #1: Determine if there is a difference in efficacy between drops of 0.5% timolol maleate administered by a professional, using the standard clinical method versus patient self-administration using the newly proposed method, in NORMAL SUBJECTS.
Aim #2: Determine if there is a difference in efficacy between glaucoma drops administered by a professional, using the standard method versus with patient self-administration of the same drop, using the newly proposed method, in GLAUCOMA PATIENTS.
JUSTIFICATION:
While new drug development in the glaucoma field seeks to address the issue of the difficulty patients experience with self-administration of an eye drop by pressing for new drugs that show efficacy in a once daily dosing routine, this strategy has potentially serious negative consequences. Clearly, when glaucoma medications are administered only once a day, if the patient misses their eye on that single instillation, the period of lapsed treatment is 24 hours or more. If their disease worsens, either due to non-compliance with their treatment regimen or inability to instill an eye drop, they will require more follow up visits, additional medications, additional diagnostic tests, and earlier surgery.
In this regard, the consequences of non-compliance or inability to comply are the same - increased blindness from glaucoma and increased costs associated with trying to prevent this blindness in needlessly advancing disease.
OBJECTIVES:
The objective of this proposal is to test the therapeutic efficacy of an alternative method of instilling eye drops. This requires comparing the effects of the same volume of the same drug, applied using the classical method and the new alternative method. If the proposed study is successful, a more reliable method for instilling drops of all kinds, to all patients, will have been validated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Professional Administration | Other | Drug: Timolol maleate 0.5% ophthalmic solutionInstillation of Timolol maleate 0.5% ophthalmic solution (or participant's own glaucoma medication) administered by a professional, using the standard clinical method. |
| Self-Administration (new method) | Other | Drug: Timolol maleate 0.5% ophthalmic solutionInstillation of Timolol maleate 0.5% ophthalmic solution (or participant's own glaucoma medication) self-administered by the participant, using the new proposed method. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- both male and female participants are being studied
- minimum age of 21 and maximum age of 80
- healthy volunteers with no previous history of eye disease
- both male and female participants are being studied
- minimum age of 21 and maximum age of 80
Key exclusion criteria (4 listed)
- no medical conditions representing contraindications to use of topical beta-blocker.
- subject must not have any active inflammatory diseases of the eye, or have a diagnosis of any form of glaucoma
- Subjects must have no other ocular disease, or a history of prior ocular trauma, beyond minor corneal abrasion or removal of a superficial corneal foreign body.
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 |
|---|---|---|
| Timolol maleate 0.5% ophthalmic solution | Drug | Professional Administration, Self-Administration (new method) |
Primary outcome
Intraocular Pressure
Time frame: 2 hours
Intraocular Pressure by Goldmann applanation will be measured pre- and 2 hours post timolol maleate 0.5% ophthalmic solution
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Timolol maleate 0.5% ophthalmic solution in people with Ophthalmic Solutions and Glaucoma, run by University of Waterloo at 1 site in Canada.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 23 Jan 2018. 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 Canada. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular Pressure (time frame: 2 hours). 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 23 Jan 2018.