Efficacy and Necessity of Time Interval Between Instillation of Two Glaucoma Eye Drops

September 27, 2021 updated by: Sheba Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria (Both groups):

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Short term: interval no-interval eye

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.
Drug: IOP reduction of Brimonidine and Timolol with time 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.
Other Names:
  • Short - interval
Drug: IOP reduction of Brimonidine and Timolol no time 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.
Other Names:
  • Short - no interval
Experimental: Short term: No-interval interval eye

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.
Drug: IOP reduction of Brimonidine and Timolol with time 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.
Other Names:
  • Short - interval
Drug: IOP reduction of Brimonidine and Timolol no time 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.
Other Names:
  • Short - no interval
Experimental: Long term: interval no-interval eye

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.
Behavioral: 5 minute interval between regular glaucoma drops - Long term
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.
Other Names:
  • Long - interval
Behavioral: no interval between regular glaucoma drops - Long term
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.
Other Names:
  • Long - no interval
Experimental: Long term: No-interval interval eye

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.
Behavioral: 5 minute interval between regular glaucoma drops - Long term
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.
Other Names:
  • Long - interval
Behavioral: no interval between regular glaucoma drops - Long term
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.
Other Names:
  • Long - no interval

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Six hour after taking the drops
Chronic group - change in IOP
Time Frame: one month
Difference between eye in IOP change from baseline after intervention
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHEBA-17-3820-AL-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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