Comparative Study of Preservative-Free vs. Preserved Dexamethasone and Diclofenac Eye Drops Post-Cataract Surgery

The primary objective of this study is to compare the efficacy and safety of **preservative-free** dexamethasone 0.1% (Monofree Dexamethason) and diclofenac 0.1% (Dicloabak) eye drops with their preserved counterparts, dexamethasone 0.1% (Maxidex) and diclofenac 0.1% (Voltaren Ophtha), in patients following **cataract** surgery. This comparison is clinically relevant as it aims to determine whether preservative-free formulations offer superior outcomes in terms of reducing postoperative inflammation and discomfort, potentially leading to improved patient compliance and satisfaction. The study does not list any secondary objectives.

The clinical trial involves participants diagnosed with **age-related cataract**, specifically targeting individuals aged 60 years or above. The study population includes both male and female subjects, with no specific vulnerable populations selected. The sponsor has not provided information regarding the total number of participants. Participants were selected based on their diagnosis of cataract and age criteria. The trial does not specify any particular lifestyle considerations such as diet, physical activity, or habits. The study aims to compare the efficacy of preservative-free eye drops versus preserved eye drops following cataract surgery.

The clinical trial is designed to compare the efficacy of **preservative-free** versus preserved eye drops in patients undergoing cataract surgery. This is a randomized, double-blind, controlled trial involving two groups: one receiving preservative-free **dexamethasone phosphate** and **diclofenac sodium** eye drops, and the other receiving preserved formulations of the same active substances. The trial is set to run from October 2018 to December 2026, with a maximum treatment period of four weeks for each participant.

Participants will undergo a series of study visits, beginning with an inclusion visit to screen for eligibility based on criteria such as age (60 years or above) and a diagnosis of age-related cataract. Following the screening, eligible participants will be randomized into one of the two treatment groups. The primary endpoint is the superiority of the preservative-free group in reducing aqueous flare value at week 4 post-surgery. Secondary endpoints include assessments of tear osmolarity, conjunctival hyperemia, corneal fluorescein staining, tear-film breakup time, corneal sensitivity, central macular thickness, DEQ-5 score, inflammatory cytokine activities in tears, amount of tears, and the effect of preservatives on the ocular surface microbiome.

Participants are expected to be involved in the study for a total of four weeks, with follow-up visits scheduled to monitor progress and collect data on the endpoints. The end-of-study visit will conclude the participant's involvement, during which final assessments will be conducted. Conditions that may lead to early termination from the study include adverse reactions to the eye drops or withdrawal of consent by the participant. The trial aims to provide valuable insights into the comparative effectiveness of preservative-free versus preserved eye drops in the management of post-cataract surgery outcomes.

The clinical trial involves the use of **Monofree Dexamethason 1 mg/ml**, an eye drop solution containing **dexamethasone phosphate** as the active substance. This medication is administered via ocular use and is provided in a single-use packaging. The dosage is set at 1 mg/ml, with a maximum daily dose of 6 drops, and the treatment period is limited to 4 weeks. The formulation is preservative-free, which is a key aspect of the study's objective to compare preservative-free versus preserved eye drops following cataract surgery. Participant compliance is monitored through regular follow-ups and adherence checks.

Another experimental treatment in the trial is **Dicloabak 1 mg/ml**, an eye drop solution containing **diclofenac sodium**. This medication is also administered via ocular use, with a dosage of 1 mg/ml and a maximum daily dose of 3 drops. The treatment duration is similarly capped at 4 weeks. Dicloabak is preservative-free, aligning with the study's aim to evaluate the effects of preservative-free formulations in post-cataract surgery care.

The comparator treatment includes **MAXIDEX 1 mg/ml**, an eye drop suspension containing **dexamethasone**. This preserved formulation is administered via ocular use, with a dosage of 1 mg/ml and a maximum daily dose of 6 drops. The treatment period is set for 4 weeks. MAXIDEX serves as a reference to assess the efficacy and safety of preservative-free alternatives in the study.

Additionally, the trial utilizes **Voltaren ophtha 1 mg/ml**, an eye drop solution containing **diclofenac sodium**. This preserved formulation is administered via ocular use, with a dosage of 1 mg/ml and a maximum daily dose of 3 drops. The treatment duration is 4 weeks. Voltaren ophtha acts as a comparator to evaluate the benefits of preservative-free eye drops in the context of post-operative care.

Efficacy in this clinical trial will be assessed by comparing the treatment outcomes of preservative-free versus preserved eye drops following cataract surgery. The primary endpoint is the superiority of the preservative-free group over the preserved group in terms of the **aqueous flare value** at week 4 post-surgery. This parameter will be measured to evaluate the inflammatory response in the anterior chamber of the eye.

Secondary endpoints include a range of ocular health indicators: tear osmolarity, conjunctival hyperemia, corneal fluorescein staining, tear-film breakup time, corneal sensitivity, central macular thickness, DEQ-5 score, inflammatory cytokine activities in tears, amount of tears, and the effect of preservatives on the ocular surface microbiome post-surgery. These parameters will provide a comprehensive assessment of the ocular surface and overall eye health following treatment.

The efficacy parameters will be collected and analyzed at specified timepoints, with the primary endpoint being assessed at week 4. The trial will utilize validated scales and laboratory tests to ensure accurate and reliable measurement of these endpoints. The data collected will be analyzed to determine the efficacy of the preservative-free eye drops compared to the preserved formulations in managing post-operative inflammation and maintaining ocular health.