Efficacy and Necessity of Time Interval Between Instillation of Two Glaucoma Eye Drops
1 other identifier
interventional
65
1 country
1
Brief 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. In this study, we aim to establish the clinical significance of keeping a time interval between glaucoma medications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2017
CompletedFirst Posted
Study publicly available on registry
July 18, 2017
CompletedStudy Start
First participant enrolled
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedOctober 4, 2021
September 1, 2021
5 years
June 19, 2017
September 27, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Acute group - difference in IOP reduction
Difference in IOP change from baseline between the two eyes after treatment
Six hour after taking the drops
Chronic group - change in IOP
Difference between eye in IOP change from baseline after intervention
one month
Study Arms (4)
Short term: interval no-interval eye
EXPERIMENTALOn 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
EXPERIMENTALOn 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
EXPERIMENTALIn 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
EXPERIMENTALIn 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.
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
- No cognitive disfunction
- able to give consent
- No known arrhythmia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheba Medical Center
Tel Litwinsky, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2017
First Posted
July 18, 2017
Study Start
November 1, 2017
Primary Completion
November 1, 2022
Study Completion
November 1, 2022
Last Updated
October 4, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share