GlaucomaNCT03220490
Efficacy and Necessity of Time Interval Between Instillation of Two Glaucoma Eye Drops
A study testing 5 minute interval between regular glaucoma drops - Long term, no interval between regular glaucoma drops - Long term and IOP reduction of Brimonidine and Timolol with time interval in people with Glaucoma and Glaucoma; Drugs, run by Sheba Medical Center at 1 site in Israel.
Trial summary
According to the American Academy of Ophthalmology's Preferred Practice Pattern on Primary Open Angle Glaucoma, patients should wait five minutes between administering topical drops for intra-ocular pressure reduction. To date, no study has shown the efficacy of this waiting period. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Glaucoma; Drugs
- What is being tested?
- 5 minute interval between regular glaucoma drops - Long term, no interval between regular glaucoma drops - Long term and IOP reduction of Brimonidine and Timolol with time interval
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2017to 1 Nov 2022
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Short duration group
- Healthy individuals with negative past ocular history
- able to give consent
- Long duration group:
- Diagnosed with primary open angle glaucoma and being treated with two types of IOP reduction drops.
- No other medical ocular history.
Show all 9Show fewer
- No cognitive disfunction
- able to give consent
- No known arrhythmia
Who cannot join
- Corneal disease preventing from visualization of the angle
- Closed angle
- Pregnant women
- Previous ocular surgery (including cataract or refractive surgery)
- Known allergy to ocular drops used in this study (e.g. brimonidine, timolol)
- History of asthma or arrhythmia
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Tel HaShomer
Ari Leshno, arileshno@gmail.com
About this study
According to the American Academy of Ophthalmology's Preferred Practice Pattern on Primary Open Angle Glaucoma, patients should wait five minutes between administering topical drops for intra-ocular pressure reduction.
To date, no study has shown the efficacy of this waiting period. In this study, we aim to establish the clinical significance of keeping a time interval between glaucoma medications.
Read the detailed description
Glaucoma is a chronic disease in which constant damage to retinal nerve fibers. In most cases the damage is caused by increased intra-ocular pressure (IOP). Without treatment, this disease can cause irreversible decrease in visual fields until the patient eventually becomes blind.
The first line of treatment include topical eye-drops aimed at reducing IOP. Many patients require more than one drug type.
According to the American Academy of Ophthalmology's Preferred Practice Pattern on Primary Open Angle Glaucoma, patients who are using two or more drop types, should wait five minutes after the first drop, before administering the second type..
To date, no study has shown the efficacy of this waiting period. In this study, we aim to establish the clinical significance of keeping a time interval between glaucoma medications.
The study composes of two separate parts:
Part 1 - The aim of this part will be to estimate the short term effect on IOP reduction. Healthy subjects willing to participate voluntarily, will be given two IOP reduction drugs (Tilopitc and Alphagan) at different intervals in each eye. After which they will undergo repeated IOP measurements over a course of 7 hours.
Part 2 - The aim of this part will be to estimate the short term effect on IOP reduction. Glaucoma patients treated in the glaucoma clinic at Sheba-Medical center who are taking two different types of IOP reduction drugs in both eyes, will be recruited. The patients will be asked to keep a constant 5 minute interval between drops in one eye and to instill the drops in the other eye with no waiting time. After one month the patients will return for a revaluation of IOP and then be asked to switch the eyes so that the eye in which the interval was not kept will now be the one in which the drop will be put after 5 minute interval.
- Conditions
- Glaucoma, Glaucoma; Drugs
- Being tested
- 5 minute interval between regular glaucoma drops - Long term, no interval between regular glaucoma drops - Long term, IOP reduction of Brimonidine and Timolol with time interval, IOP reduction of Brimonidine and Timolol no time interval
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 minute interval between regular glaucoma drops - Long termBehavioural
Also called Long - interval
In the selected eye, the patient will be asked to take his two regular IOP reduction drugs while keeping a five minute time interval between instillation of the first and second drug for a duration of one month.
no interval between regular glaucoma drops - Long termBehavioural
Also called Long - no interval
In the selected eye, the patient will be asked to take his two regular IOP reduction drugs one after the other with no waiting period for a duration of one month.
IOP reduction of Brimonidine and Timolol with time intervalDrug
Also called Short - interval
In the selected eye the subject will be given two types of IOP reduction drops: first "Brimonidine", "Alphagan®" (an alpha-agonist) followed by "Timolol", "Tiloptic®" (a beta-blocker). The drops will be given with a time interval of five minutes between the first and second drop.
IOP reduction of Brimonidine and Timolol no time intervalDrug
Also called Short - no interval
In the selected eye the subject will be given two types of IOP reduction drops:first "Brimonidine", "Alphagan®" (an alpha-agonist) followed by "Timolol", "Tiloptic®" (a beta-blocker). The drops will be given one after the other with no waiting period.
| Study group | Role | What they receive |
|---|---|---|
| Short term: interval no-interval eye | Experimental | On the first day of the study, in the selected eye the investigators will examine the short term effect of IOP reduction of Brimonidine and Timolol with time interval.
One drop of two types of IOP reduction drugs (Brimonidine and Timolol) will be given with a 5 minutes interval between the first (Brimonidine) and the second (Timolol) drop. IOP measurements will be taken every hour up to 6 hours after treatment.
On the second day of the study (two weeks after the first day) the investigators will examine the short term effect of IOP reduction of Brimonidine and Timolol no time interval. Again one drop of the same two types of drugs will be given at the same order but with no time interval between them. IOP measurements will be taken in the same manner as on the first day. Receives: Drug: IOP reduction of Brimonidine and Timolol with time interval; Drug: IOP reduction of Brimonidine and Timolol no time interval |
| Short term: No-interval interval eye | Experimental | On the first day of the study, in the selected eye the investigators will examine the short term effect of IOP reduction of Brimonidine and Timolol with time interval.
One drop of two types of IOP reduction drugs (Brimonidine and Timolol) will be given with no waiting period between the first (Brimonidine) and the second (Timolol) drop. IOP measurements will be taken every hour up to 6 hours after treatment.
On the second day of the study (two weeks after the first day) the investigators will examine the short term effect of IOP reduction of Brimonidine and Timolol with time interval. Again one drop of the same two drugs will be given at the same order but with a five minute time interval between the first and second drop. IOP measurements will be taken in the same manner. Receives: Drug: IOP reduction of Brimonidine and Timolol with time interval; Drug: IOP reduction of Brimonidine and Timolol no time interval |
| Long term: interval no-interval eye | Experimental | In the first phase the effect of 5 minute interval between regular glaucoma drops - long term will be examined. The patients will be asked in this eye to wait 5 minutes after taking one of their IOP reduction drugs, before instilling the second type for a total duration of 1 month.
After the one month has passed IOP measurement will be taken and the patients will be asked to switch to the no interval between regular glaucoma drops - long term phase in which they will be asked to take the drops for this eye at the same order but with no waiting period for a duration of 1 month. After the second month has passed IOP measurements will be repeated. Receives: Behavioral: 5 minute interval between regular glaucoma drops - Long term; Behavioral: no interval between regular glaucoma drops - Long term |
| Long term: No-interval interval eye | Experimental | In the first phase no interval between regular glaucoma drops - Long term will be examined. The patients will be asked in this eye to take both IOP reduction drugs, with no waiting period between them for a total duration of 1 month.
After the one month has passed IOP measurement will be taken and the patient will be asked to switch to the to 5 minute interval between regular glaucoma drops - Long term phase and take the drops for the same eye at the same order but with a five minute waiting period for a duration of 1 month. After the second month has passed IOP measurements will be repeated. Receives: Behavioral: 5 minute interval between regular glaucoma drops - Long term; Behavioral: no interval between regular glaucoma drops - Long term |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute group - difference in IOP reduction
Difference in IOP change from baseline between the two eyes after treatment
Measured: Six hour after taking the drops
Chronic group - change in IOP
Difference between eye in IOP change from baseline after intervention
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start1 Nov 2017
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Nov 2022 (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.
- More trials run by Sheba Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220490
- Sponsor's protocol ID
- SHEBA-17-3820-AL-CTIL
- Status last verified
- Sep 2021
- First submitted
- 19 Jun 2017
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Necessity of Time Interval Between Instillation of Two Glaucoma Eye Drops
- ClinicalTrials.gov ID
- NCT03220490
- Acronym / sponsor ID
- SHEBA-17-3820-AL-CTIL
- Conditions
- Glaucoma, Glaucoma; Drugs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 18 Jul 2017 (actual)
- 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.
According to the American Academy of Ophthalmology's Preferred Practice Pattern on Primary Open Angle Glaucoma, patients should wait five minutes between administering topical drops for intra-ocular pressure reduction.
To date, no study has shown the efficacy of this waiting period. In this study, we aim to establish the clinical significance of keeping a time interval between glaucoma medications.
Detailed description
Glaucoma is a chronic disease in which constant damage to retinal nerve fibers. In most cases the damage is caused by increased intra-ocular pressure (IOP). Without treatment, this disease can cause irreversible decrease in visual fields until the patient eventually becomes blind.
The first line of treatment include topical eye-drops aimed at reducing IOP. Many patients require more than one drug type.
According to the American Academy of Ophthalmology's Preferred Practice Pattern on Primary Open Angle Glaucoma, patients who are using two or more drop types, should wait five minutes after the first drop, before administering the second type..
To date, no study has shown the efficacy of this waiting period. In this study, we aim to establish the clinical significance of keeping a time interval between glaucoma medications.
The study composes of two separate parts:
Part 1 - The aim of this part will be to estimate the short term effect on IOP reduction. Healthy subjects willing to participate voluntarily, will be given two IOP reduction drugs (Tilopitc and Alphagan) at different intervals in each eye. After which they will undergo repeated IOP measurements over a course of 7 hours.
Part 2 - The aim of this part will be to estimate the short term effect on IOP reduction. Glaucoma patients treated in the glaucoma clinic at Sheba-Medical center who are taking two different types of IOP reduction drugs in both eyes, will be recruited. The patients will be asked to keep a constant 5 minute interval between drops in one eye and to instill the drops in the other eye with no waiting time. After one month the patients will return for a revaluation of IOP and then be asked to switch the eyes so that the eye in which the interval was not kept will now be the one in which the drop will be put after 5 minute interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Short term: interval no-interval eye | Experimental | Drug: IOP reduction of Brimonidine and Timolol with time interval, Drug: IOP reduction of Brimonidine and Timolol no time intervalOn the first day of the study, in the selected eye the investigators will examine the short term effect of IOP reduction of Brimonidine and Timolol with time interval. One drop of two types of IOP reduction drugs (Brimonidine and Timolol) will be given with a 5 minutes interval between the first (Brimonidine) and the second (Timolol) drop. IOP measurements will be taken every hour up to 6 hours after treatment. On the second day of the study (two weeks after the first day) the investigators will examine the short term effect of IOP reduction of Brimonidine and Timolol no time interval. Again one drop of the same two types of drugs will be given at the same order but with no time interval between them. IOP measurements will be taken in the same manner as on the first day. |
| Short term: No-interval interval eye | Experimental | Drug: IOP reduction of Brimonidine and Timolol with time interval, Drug: IOP reduction of Brimonidine and Timolol no time intervalOn the first day of the study, in the selected eye the investigators will examine the short term effect of IOP reduction of Brimonidine and Timolol with time interval. One drop of two types of IOP reduction drugs (Brimonidine and Timolol) will be given with no waiting period between the first (Brimonidine) and the second (Timolol) drop. IOP measurements will be taken every hour up to 6 hours after treatment. On the second day of the study (two weeks after the first day) the investigators will examine the short term effect of IOP reduction of Brimonidine and Timolol with time interval. Again one drop of the same two drugs will be given at the same order but with a five minute time interval between the first and second drop. IOP measurements will be taken in the same manner. |
| Long term: interval no-interval eye | Experimental | Behavioral: 5 minute interval between regular glaucoma drops - Long term, Behavioral: no interval between regular glaucoma drops - Long termIn the first phase the effect of 5 minute interval between regular glaucoma drops - long term will be examined. The patients will be asked in this eye to wait 5 minutes after taking one of their IOP reduction drugs, before instilling the second type for a total duration of 1 month. After the one month has passed IOP measurement will be taken and the patients will be asked to switch to the no interval between regular glaucoma drops - long term phase in which they will be asked to take the drops for this eye at the same order but with no waiting period for a duration of 1 month. After the second month has passed IOP measurements will be repeated. |
| Long term: No-interval interval eye | Experimental | Behavioral: 5 minute interval between regular glaucoma drops - Long term, Behavioral: no interval between regular glaucoma drops - Long termIn the first phase no interval between regular glaucoma drops - Long term will be examined. The patients will be asked in this eye to take both IOP reduction drugs, with no waiting period between them for a total duration of 1 month. After the one month has passed IOP measurement will be taken and the patient will be asked to switch to the to 5 minute interval between regular glaucoma drops - Long term phase and take the drops for the same eye at the same order but with a five minute waiting period for a duration of 1 month. After the second month has passed IOP measurements will be repeated. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Short duration group
- Healthy individuals with negative past ocular history
- able to give consent
- Diagnosed with primary open angle glaucoma and being treated with two types of IOP reduction drops.
- No other medical ocular history.
Key exclusion criteria (6 listed)
- Corneal disease preventing from visualization of the angle
- Closed angle
- Pregnant women
- Previous ocular surgery (including cataract or refractive surgery)
- Known allergy to ocular drops used in this study (e.g. brimonidine, timolol)
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 |
|---|---|---|
| 5 minute interval between regular glaucoma drops - Long termAlso: Long - intervalIn the selected eye, the patient will be asked to take his two regular IOP reduction drugs while keeping a five minute time interval between instillation of the first and second drug for a duration of one month. | Behavioural | Long term: No-interval interval eye, Long term: interval no-interval eye |
| no interval between regular glaucoma drops - Long termAlso: Long - no intervalIn the selected eye, the patient will be asked to take his two regular IOP reduction drugs one after the other with no waiting period for a duration of one month. | Behavioural | Long term: No-interval interval eye, Long term: interval no-interval eye |
| IOP reduction of Brimonidine and Timolol with time intervalAlso: Short - intervalIn the selected eye the subject will be given two types of IOP reduction drops: first "Brimonidine", "Alphagan®" (an alpha-agonist) followed by "Timolol", "Tiloptic®" (a beta-blocker). The drops will be given with a time interval of five minutes between the first and second drop. | Drug | Short term: No-interval interval eye, Short term: interval no-interval eye |
| IOP reduction of Brimonidine and Timolol no time intervalAlso: Short - no intervalIn the selected eye the subject will be given two types of IOP reduction drops:first "Brimonidine", "Alphagan®" (an alpha-agonist) followed by "Timolol", "Tiloptic®" (a beta-blocker). The drops will be given one after the other with no waiting period. | Drug | Short term: No-interval interval eye, Short term: interval no-interval eye |
Primary outcome
Acute group - difference in IOP reduction
Time frame: Six hour after taking the drops
Difference in IOP change from baseline between the two eyes after treatment
Chronic group - change in IOP
Time frame: one month
Difference between eye in IOP change from baseline after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5 minute interval between regular glaucoma drops - Long term, no interval between regular glaucoma drops - Long term and IOP reduction of Brimonidine and Timolol with time interval in people with Glaucoma and Glaucoma; Drugs, run by Sheba Medical Center at 1 site in Israel.
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 9 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 4 Oct 2021. 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 Israel. 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 Ari Leshno, MD (+972-3-5302872, ari.leshano@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute group - difference in IOP reduction (time frame: Six hour after taking the drops). The study lists 2 primary outcomes in all. 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 4 Oct 2021.