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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03220490
• Other study ID #: SHEBA-17-3820-AL-CTIL
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: November 1, 2022

Study information

• Verified date: September 2021
• Source: Sheba Medical Center
• Contact: Ari Leshno, MD
• Phone: +972-3-5302872
• Email: ari.leshano[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma; Drugs

Intervention

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.
• 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.

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.
• 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.

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel HaShomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute group - difference in IOP reduction	Difference in IOP change from baseline between the two eyes after treatment	Six hour after taking the drops
Primary	Chronic group - change in IOP	Difference between eye in IOP change from baseline after intervention	one month