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

  • STATUS
    Recruiting
  • End date
    Nov 1, 2022
  • participants needed
    65
  • sponsor
    Sheba Medical Center
Updated on 10 October 2021
beta blockers
glaucoma
brimonidine tartrate ophthalmic solution
timolol
brimonidine
primary open angle glaucoma
bilateral glaucoma
brimonidine/timolol
Accepts healthy volunteers

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.

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.

Details
Condition Glaucoma; Drugs, Ocular Hypertension, Glaucoma
Treatment 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
Clinical Study IdentifierNCT03220490
SponsorSheba Medical Center
Last Modified on10 October 2021

Eligibility

Yes No Not Sure

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

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
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