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Study Comparing Bimatoprost Eye Drops with Lumigan for Patients with Chronic Open-Angle Glaucoma or Ocular Hypertension

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying two eye conditions: Chronic Open-angle Glaucoma and Ocular Hypertension. These conditions involve increased pressure in the eye, which can lead to vision problems if not managed properly. The study will compare two treatments: a preservative-free version of Bimatoprost eye drops, known by the code name BIM-001, and a reference product called Lumigan, which also contains Bimatoprost. Both treatments are designed to help lower the pressure inside the eye.

The purpose of this study is to evaluate how effective, safe, and tolerable these treatments are for patients with the mentioned eye conditions. Participants will be randomly assigned to one of the two treatment groups. The study will last for a period of 42 days, during which participants will use the eye drops as directed. Throughout the study, the pressure in the eyes will be monitored, and any side effects or changes in eye health will be recorded.

Participants will visit the study center several times to have their eye pressure checked and to discuss any changes in their condition. The study aims to determine which treatment is more effective in reducing eye pressure and how well patients tolerate each treatment. This information will help doctors make better treatment decisions for people with Chronic Open-angle Glaucoma or Ocular Hypertension.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will provide informed consent, confirming understanding and willingness to follow the study protocol.
Eligibility is confirmed based on criteria such as age (18 years or older) and diagnosis of chronic open-angle glaucoma or ocular hypertension.
Step 2
Initial assessment
An initial assessment is conducted to measure baseline intraocular pressure (IOP) and best corrected visual acuity (BCVA).
Baseline IOP should be greater than 21 mm Hg and less than or equal to 35 mm Hg in one or both eyes.
Step 3
Medication administration
The patient is randomly assigned to one of two groups: one receiving preservative-free bimatoprost ophthalmic solution 0.1 mg/ml, and the other receiving Lumigan® (bimatoprost ophthalmic solution) 0.1 mg/ml.
The medication is administered as eye drops, with the specific dosage and frequency determined by the study protocol.
Step 4
Follow-up visits
Follow-up visits are scheduled to monitor the reduction in IOP and assess the local tolerability of the treatment.
These visits include evaluations using the Ocular Surface Disease Index (OSDI), Efron scale, and Oxford scale.
Step 5
Final assessment
A final assessment is conducted on day 42 to compare the mean percentage reduction in IOP from baseline between the two treatment groups.
Safety is evaluated through the reporting of any adverse events experienced during the study.

Who can join the trial?

6 criteria

Patients must be willing and able to give their agreement to participate and follow the study rules.
Both men and women who are **18 years or older** can participate.
Patients must have **chronic open-angle glaucoma** or **ocular hypertension** in one or both eyes. **Chronic open-angle glaucoma** is a condition where the pressure inside the eye is too high, which can damage the optic nerve. **Ocular hypertension** means having higher than normal pressure in the eye without any signs of glaucoma.
Patients should be able to change their eye pressure-lowering medications and have a break from them, as decided by the study doctor.
At the start of the study, the pressure inside the eye, known as **intraocular pressure (IOP)**, should be more than **21 mm Hg** and less than or equal to **35 mm Hg** in one or both eyes. **Intraocular pressure** is the fluid pressure inside the eye.
At the start of the study, the best possible vision with glasses or contact lenses, called **best corrected visual acuity (BCVA)**, should be equivalent to a **Snellen acuity** of **20/200** or better in each eye. **Snellen acuity** is a way to measure how well you can see at a distance.

Who cannot join the trial?

7 criteria

Patients who have any other eye diseases besides Chronic Open-angle Glaucoma or Ocular Hypertension.
Patients who have had eye surgery in the last 3 months.
Patients who are currently using other eye medications that might interfere with the study.
Patients who have a known allergy to the study medication or similar medications.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial in the last 30 days.
Patients who have any serious health conditions that might affect their ability to participate in the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliero-Universitaria Sant Andre
Responsive
Rome, Italy
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo
Verified
Milan, Italy
IRCCS Ospedale Policlinico San Martino
Verified
Genoa, Italy

Trial locations

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Investigated drugs

Bimatoprost Ophthalmic Solution
is an eye drop used to lower high pressure inside the eye. It is often prescribed for patients with chronic open-angle glaucoma or ocular hypertension. This medication helps to prevent further damage to the optic nerve and loss of vision by increasing the outflow of fluid from the eye, thereby reducing the pressure.
Lumigan
is another form of bimatoprost ophthalmic solution. It is also used to treat high eye pressure in patients with chronic open-angle glaucoma or ocular hypertension. Like the preservative-free version, Lumigan works by increasing the drainage of fluid from the eye, which helps to lower the pressure and protect the optic nerve from damage.

Bimatoprost

What is already known about the treatment

Bimatoprost Ophthalmic Solution – This medication is administered as eye drops and is used to treat chronic open-angle glaucoma and ocular hypertension. It is currently being studied in clinical trials to compare its efficacy and safety with Lumigan, a similar formulation. Bimatoprost works by increasing the outflow of fluid from the eye, which helps to lower intraocular pressure. It belongs to the pharmacological class of prostaglandin analogs, which are commonly used to manage elevated eye pressure.

Investigated diseases

Chronic Open-angle Glaucoma
This is a common eye condition where the drainage canals in the eyes become clogged over time, leading to increased eye pressure. It progresses slowly and can cause damage to the optic nerve, which may result in vision loss if not managed. The condition often develops without noticeable symptoms, making regular eye exams crucial for early detection. As the disease advances, peripheral vision may gradually decrease, eventually affecting central vision.
Ocular Hypertension
This condition is characterized by higher-than-normal pressure inside the eye, known as intraocular pressure, without any detectable changes in vision or damage to the eye structures. It is not a disease itself but a risk factor for developing glaucoma. Ocular hypertension progresses without symptoms, so it is usually identified during routine eye examinations. Monitoring and managing eye pressure are important to prevent potential progression to glaucoma.