Study Comparing Brinzolamide and Timolol Eye Drops for Patients with Glaucoma or Ocular Hypertension

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What is this study about?

This clinical trial is focused on studying the effects of two different eye drop treatments for patients with Glaucoma and Ocular Hypertension. These conditions involve increased pressure inside the eye, which can lead to vision problems if not managed properly. The study will compare a new generic combination of eye drops containing Brinzolamide and Timolol with an existing product called Azarga, which also contains the same active ingredients.

The purpose of the study is to determine if the new generic eye drops are as effective and well-tolerated as the Azarga eye drops in reducing eye pressure. Participants in the study will be randomly assigned to use either the generic eye drops or Azarga. The study will be conducted in a way that neither the participants nor the observers know which treatment is being used, to ensure unbiased results.

Throughout the study, participants will use the eye drops as directed and attend regular follow-up visits to monitor their eye pressure and overall eye health. The study will last for several weeks, during which the average change in eye pressure will be measured and compared between the two groups. This will help determine if the new generic eye drops are a suitable alternative for managing eye pressure in patients with glaucoma or ocular hypertension.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose, which is to compare the effectiveness and tolerability of a new generic combination of brinzolamide and timolol eye drops with the reference product Azarga® eye drops.

The patient will be required to provide written informed consent and a data protection declaration before any trial-related procedures are performed.

2 medication administration

The patient will be randomly assigned to receive either the generic combination of brinzolamide 10mg/mL and timolol 5mg/mL eye drops or the reference product Azarga® eye drops.

The eye drops are to be administered as per the study protocol, which involves using them as eye drops, suspension.

3 monitoring and follow-up

The patient’s intraocular pressure (IOP) will be monitored throughout the study to assess the effectiveness of the treatment.

Follow-up visits will be scheduled at specific intervals, including at baseline (week 0), week 2, week 6, and week 12, to measure changes in IOP and monitor any adverse events related to the study drugs.

4 completion of the study

The primary endpoint of the study is to evaluate the difference in mean diurnal IOP change from baseline to the week 12 visit.

Secondary endpoints include evaluating the difference in mean diurnal IOP change at weeks 2 and 6, as well as the frequency of any adverse events related to the study drugs.

Who Can Join the Study?

Must be a male or female, of any race, and at least 18 years old.
Must have been diagnosed with either one or both eyes having open angle glaucoma (a type of eye condition that can lead to vision loss) or ocular hypertension (higher than normal pressure inside the eye). This can be either currently under treatment or not yet treated.
Must be able to safely stop using all eye pressure-lowering medications and go through a period without them.
Must have a best-corrected visual acuity of at least 20 out of 100 in both eyes. This means the best vision you can achieve with glasses or contact lenses.
Females participating must either be unable to become pregnant (due to menopause, surgical procedures like removal of ovaries or uterus, or having tubes tied) or, if they can become pregnant and are sexually active, must use effective birth control methods during the study. These methods include hormonal birth control, devices placed inside the uterus, having a partner who has had a vasectomy, or choosing not to have sex.
The investigator must expect that the eye pressure will stay controlled with treatment, without damage to the optic nerve or worsening of vision.
Must be able to understand what the clinical trial involves and agree to come back for follow-up visits as required.
Must be willing to provide written consent and agree to data protection before any trial-related procedures are done.

Who Cannot Join the Study?

Patients with any other eye disease besides ocular hypertension or glaucoma cannot participate. Ocular hypertension means higher pressure inside the eye, and glaucoma is a condition that can damage the eye’s optic nerve.
Patients who have had eye surgery in the last 3 months are not eligible.
Patients using other eye medications that might interfere with the study cannot join.
Patients with severe allergies to the study medications are excluded.
Pregnant or breastfeeding women cannot participate.
Patients with uncontrolled medical conditions that might affect the study results are not eligible.
Patients who are unable to follow the study procedures or attend all visits are excluded.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Ippokratio General Hospital Of Thessaloniki	Thessaloniki	Greece
Iaso Thessalia General Clinic Private Obstetrics S.A.	Larissa	Greece
401 General Military Hospital Of Athens	Athens	Greece
General University Hospital Of Larissa	Larissa	Greece
University General Hospital Of Thessaloniki Ahepa	Thessaloniki	Greece
Sbttepmoagbs Grtsucy Hjlhcblf	Athens	Greece
Gqdbowm Hemfuxdm Ok Kzbrgqio	Karditsa	Greece
Oznlixwllwtflmxt Arfxvms	Athens	Greece
Gdympdi Hogatwrw om Kjbfdq	Kavala	Greece
Gdogfnv Hghzhsli Or Vaezh Akvexiaovuozv	Volos	Greece
Gegdfba Hlwnauna om Ktqwkhou	Katerini	Greece
Lpnqa Glhkpkp Htubmtlc Oz Audvit	Athens	Greece
Uvetcwtkxx Gdpgzgy Hvadpbtr Afusern	Athens	Greece

Trial status

Country	Status	Recruitment Start
Greece	Not recruiting	01.03.2024

Trial locations

Investigated drugs:

Brinzolamide and Timolol Eye Drops are a combination medication used to lower high pressure inside the eye, which can occur in conditions like open-angle glaucoma or ocular hypertension. Brinzolamide works by reducing the production of fluid within the eye, while Timolol helps by decreasing the amount of fluid produced and improving fluid drainage. Together, they help to prevent damage to the optic nerve and loss of vision by maintaining a healthy eye pressure.

Azarga is an eye drop medication that also combines Brinzolamide and Timolol. It is used to treat high eye pressure in patients with open-angle glaucoma or ocular hypertension. Like the generic combination, Azarga works by reducing the production of fluid in the eye and improving fluid drainage, helping to lower the pressure and protect the optic nerve from damage.

Ocular Hypertension – Ocular hypertension occurs when the pressure inside the eye, known as intraocular pressure, is higher than normal. This condition does not cause any noticeable symptoms, which makes it difficult to detect without regular eye exams. Over time, if left untreated, the elevated pressure can lead to damage of the optic nerve. Unlike glaucoma, ocular hypertension does not involve any detectable changes in vision or damage to the optic nerve initially. It is considered a risk factor for developing glaucoma. Regular monitoring is essential to prevent progression to more serious conditions.

Glaucoma – Glaucoma is a group of eye conditions that damage the optic nerve, often due to high intraocular pressure. It is one of the leading causes of blindness for people over the age of 60. The most common form, open-angle glaucoma, progresses slowly and painlessly, often without noticeable symptoms until significant vision loss occurs. In some cases, individuals may experience peripheral vision loss, which can progress to tunnel vision. The damage caused by glaucoma is irreversible, making early detection crucial. Regular eye examinations are important for those at risk to prevent severe vision impairment.

Trial ID:

2023-506494-35-00

Protocol code:

BECRO/OV/BRINZOTIM

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Brinzolamide and Timolol Eye Drops for Patients with Glaucoma or Ocular Hypertension

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