NCT06404541

A Comparative Study Between Preservative With Benzalkonium Chloride vs Preservative Free Eye Drops on the Ocular Surface

A Comparison Between the Ocular Surface of Different Concentrations of Benzalkonium Chloride Preservative in Postoperative Topical Medications After Cataract Surgery

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Kasr El Aini Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

Summary

study the effect of different concentrations of benzalkonium chloride on the ocular surface of non-dry-eyed patients post cataract surgery.

Detailed description

60 eyes of will be included in this study. * 20 eyes will receive regular Tobradex 0.1mg/ml BAK 5 times per day (Group 1). * 20 eyes will receive Dexathalm multidose 0.05mg/ml BAK 5 times per day (Group 2). * 20 eyes will receive single dose unit Dexathalm NO BAK 5 times per day (Group 3). Preoperative assessment: All selected patients will receive thorough explanation of the study design and aims, an informed consent will be obtained from all patients. Tear break up time (TBUT) will be measured non-invasively by Ocular Surface analyzer. Ocular Surface disease index will be calculated by filling a questionnaire. 12-item questionnaire provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning. Postoperative: 1. All patients will be examined at day1, 1 week and 3 week postoperative. 2. At 3 weeks re-evaluate I. TBUT by non-invasive ocular surface analyzer II. OSDI by filling the questionnaire.

Conditions

• Ocular Surface Disease
• Dry Eye Syndromes

Interventions

Type	Name	Description
DRUG	Dexamethasone, tobramycin, netilimicin	Group A: Dexathalm single dose Group B: Tobradex Group C: Dexathalm multi-dose

Timeline

• Start date: 2024-01-10
• Primary completion: 2024-04-10
• Completion: 2024-05-01
• First posted: 2024-05-08
• Last updated: 2024-05-08

Locations

1 site across 1 country: Egypt