Randomized, Open-Label, Multicenter Study Comparing Preservative-Free Bimatoprost Ophthalmic Solution 0.1 mg/mL with Lumigan in Chronic Open-Angle Glaucoma or Ocular Hypertension

The primary objective of this study is to evaluate the **efficacy**, tolerability, and safety of a preservative-free Bimatoprost ophthalmic solution 0.1 mg/ml compared to the reference product, Lumigan® (Bimatoprost ophthalmic solution) 0.1 mg/ml, in patients diagnosed with **Chronic Open-angle Glaucoma** or **Ocular Hypertension**. This comparison is clinically relevant as it aims to determine whether the preservative-free formulation offers similar or improved therapeutic benefits and safety profile, potentially enhancing patient adherence and reducing preservative-related side effects.

The clinical trial involves participants diagnosed with **Chronic Open-angle Glaucoma** or **Ocular Hypertension**. The study population includes both male and female subjects aged 18 years and older. Participants are required to have a baseline intraocular pressure (IOP) greater than 21 mm Hg and less than or equal to 35 mm Hg in one or both eyes, with a best corrected visual acuity equivalent to Snellen acuity of 20/200 or better in each eye. The trial does not include a vulnerable population. Participants must be willing and able to provide informed consent and adhere to protocol requirements. The sponsor has not provided information regarding the total number of participants. Lifestyle factors such as diet, physical activity, or habits are not specified as part of the study criteria. The selection process allows for patients to switch ocular hypotensive medications and undergo an appropriate washout period at the clinical investigator's discretion.

The clinical trial is designed as a **randomized**, open-label, parallel-group, two-arm, multicenter study. It aims to evaluate the efficacy, tolerability, and safety of a preservative-free **bimatoprost** ophthalmic solution 0.1 mg/ml compared to Lumigan® (bimatoprost ophthalmic solution) 0.1 mg/ml in patients with **chronic open-angle glaucoma** or **ocular hypertension**. The trial will involve a total treatment period of 42 days, with the estimated end date set for August 1, 2024. Participants will be randomly assigned to one of the two treatment groups and will receive the respective ophthalmic solution for the duration of the study.

The sequence of study visits includes an initial screening visit to assess eligibility based on specific inclusion criteria, such as age (≥18 years), diagnosis of chronic open-angle glaucoma or ocular hypertension, and baseline intraocular pressure (IOP) > 21 mm Hg and ≤ 35 mm Hg. Following the screening, participants will undergo a baseline visit (V2) where treatment will commence. Subsequent follow-up visits will occur at predetermined intervals to monitor IOP reduction, assess local tolerability using the Ocular Surface Disease Index (OSDI), Efron scale, and Oxford scale, and evaluate safety through the reporting of adverse events. The end-of-study visit (V5) will take place on day 42, marking the conclusion of the treatment period.

Participant involvement is expected to last for the entire 42-day treatment period unless conditions arise that necessitate early termination. Such conditions may include significant adverse events, non-compliance with the study protocol, or withdrawal of consent. The primary endpoint of the study is the difference in IOP between the two treatment groups, measured as the mean percentage reduction from baseline to day 42. Secondary endpoints include the reduction in IOP at each follow-up time point, local tolerability assessments, and a comprehensive evaluation of safety. The trial is not classified as a low-intervention study and is categorized as a Phase III trial, indicating its advanced stage in the clinical research process.

The clinical trial involves the administration of **Bimatoprost 0.1 mg/ml**, an ophthalmic solution provided in a single-dose container. This experimental medication is designed for **ophthalmic use** and is classified as a prostaglandin analog. The solution is manufactured by Genetic S.P.A. and is intended for the treatment of patients with **chronic open-angle glaucoma** or **ocular hypertension**. The dosage regimen involves a maximum daily dose of 0.05 mg/ml, with a total maximum dose of 2.1 mg/ml over a treatment period of 42 days. The administration is conducted once daily, and participant compliance is monitored throughout the study to ensure adherence to the dosing schedule.

The comparator treatment in this study is **Lumigan 0.1 mg/ml eye drops**, a solution also containing **bimatoprost** as the active ingredient. This non-experimental treatment is provided by AbbVie Deutschland GmbH & Co. KG and is similarly classified as a prostaglandin analog for **ophthalmic use**. The dosage and administration schedule for Lumigan mirror those of the experimental medication, with a maximum daily dose of 0.05 mg/ml and a total maximum dose of 2.1 mg/ml over the same 42-day treatment period. The study aims to compare the efficacy, tolerability, and safety of the experimental Bimatoprost formulation against the established Lumigan treatment in the specified patient population.

The efficacy of the clinical trial will be assessed by evaluating the primary and secondary endpoints. The primary endpoint focuses on the difference in **intraocular pressure (IOP)** of one eye between the two treatment groups, specifically measuring the mean percentage reduction from baseline to day 42. This will be assessed in patients with chronic open-angle glaucoma or ocular hypertension. The secondary endpoints include the reduction in IOP at each follow-up time point compared to baseline in both study groups. Additionally, local tolerability will be evaluated using the Ocular Surface Disease Index (OSDI), Efron scale, and Oxford scale from baseline to day 42. Safety will be assessed through both quantitative and qualitative evaluations of adverse events reported during the trial.