Evaluation of Preoperative Nepafenac and Dexamethasone on Postoperative Intraocular Inflammation in Patients Undergoing Cataract Surgery

The primary objective of this study is to compare postoperative **intraocular inflammation** between different medication regimens for **cataract** surgery. This is clinically relevant as managing inflammation effectively can improve surgical outcomes and patient recovery. The study evaluates the role of preoperative non-steroidal anti-inflammatory drugs (NSAIDs) in reducing inflammation, which is a common complication following cataract surgery. The medications under investigation include NEVANAC 3 mg/ml eye drops, containing **nepafenac**, and Spersadex 1 mg/ml eye drops, containing **dexamethasone**. These medications are administered via the ophthalmic route, and their efficacy in controlling inflammation post-surgery is critical for optimizing patient care and minimizing postoperative complications.

The clinical trial focuses on evaluating postoperative intraocular inflammation in patients undergoing cataract surgery. The study population includes **adults aged 18 years and older**, with no upper age limit specified. Both **male and female** participants are included, and the trial does not involve a vulnerable population. Participants are selected based on their scheduled procedures, either standard phacoemulsification cataract surgery or combined with a minimally invasive glaucoma surgery (MIGS) stent. The trial requires participants to be capable of cooperating during examinations and willing to comply with the study's requirements. The sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet or physical activity.

The clinical trial is designed to evaluate the efficacy of different medication regimens in managing postoperative intraocular inflammation following **cataract** surgery. This study employs a randomized, double-blind, controlled trial design to ensure the reliability and validity of the results. The trial is expected to span from May 1, 2022, to December 31, 2030, allowing for comprehensive data collection and analysis. Participants will be randomly assigned to receive either **nepafenac** or **dexamethasone** in the form of ophthalmic eye drops, with the primary endpoint being the measurement of laser flare, an indicator of intraocular inflammation.

Study visits are structured to include an initial screening visit, where eligibility is confirmed based on criteria such as age (18 years and older), scheduled cataract surgery, and the ability to comply with study requirements. Following the screening, participants will undergo a series of follow-up visits to monitor the treatment's effects and any adverse reactions. The end-of-study visit will conclude the participant's involvement, during which final assessments will be conducted to evaluate the primary and any secondary endpoints.

The expected duration of participant involvement is approximately three months, corresponding to the maximum treatment period for the eye drops. Conditions that may lead to early termination from the study include non-compliance with the protocol, withdrawal of consent, or the occurrence of significant adverse events. The trial's methodology and design are meticulously crafted to ensure the collection of robust data, contributing to the understanding of optimal preoperative medication regimens for cataract surgery.

The clinical trial involves the use of **NEVANAC 3 mg/ml eye drops, suspension**, which contains the active substance **nepafenac**. This medication is formulated as an eye drop suspension and is administered via the **ophthalmic** route. The dosage regimen for NEVANAC is one drop per eye, administered once daily. The maximum total dose is 21 drops over a treatment period of up to 3 days. NEVANAC is a chemically derived medication, and its use in this trial is to evaluate its efficacy in managing postoperative intraocular inflammation following cataract surgery.

Another treatment used in the trial is **Spersadex 1 mg/ml eye drops, solution**, which contains the active substance **dexamethasone**. This medication is also administered via the ophthalmic route and is formulated as an eye drop solution. The dosing schedule for Spersadex involves administering one drop per eye, up to five times daily, with a maximum total dose of 35 drops over a 3-day treatment period. Like NEVANAC, Spersadex is chemically derived and is used in the trial to compare its effects on postoperative intraocular inflammation with other medication regimens.

Both NEVANAC and Spersadex are not pediatric formulations and are not classified as orphan drugs. The trial aims to compare the postoperative intraocular inflammation between these different medication regimens in the context of cataract surgery. Participant compliance with the dosing schedule is monitored to ensure adherence to the treatment protocol.

Efficacy in this clinical trial will be assessed by comparing postoperative intraocular inflammation between different medication regimens for cataract surgery. The primary endpoint for evaluating efficacy is the measurement of **laser flare**, which is an indicator of intraocular inflammation. This parameter will be collected and analyzed to determine the effectiveness of the treatment regimens. The trial involves the use of two ophthalmic products: NEVANAC 3 mg/ml eye drops, suspension, containing the active substance **nepafenac**, and Spersadex 1 mg/ml eye drops, solution, containing the active substance **dexamethasone**. Both products are administered via the ophthalmic route. The trial is designed to include patients aged 18 years and older who are scheduled for standard phacoemulsification cataract surgery or combined phacoemulsification cataract surgery with MIGS stent. The study is set to conclude by December 31, 2030, with recruitment having started on May 1, 2022.