Suspended

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Dexamethasone, tobramycin, netilimicin

Drug
Who is being recruted

Eye Diseases

+ Lacrimal Apparatus Diseases

+ Dry Eye Syndromes

From 40 to 70 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: January 2024
See protocol details

Summary

Principal SponsorKasr El Aini Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 10, 2024

Actual date on which the first participant was enrolled.

This study is focused on understanding how different concentrations of a preservative called Benzalkonium Chloride (BAK) in eye medications affect the eye's surface after cataract surgery. Cataract surgery patients often need to use eye drops to aid recovery, and these drops can contain preservatives like BAK, which might impact the health of the eye surface. The study includes 60 eyes, split into three groups, each receiving different formulations of eye drops. The aim is to determine the best concentration of BAK that maintains eye health while still being effective, potentially improving recovery for future patients undergoing cataract surgery. Participants will be divided into three groups, with each group receiving a different eye drop regimen. Group 1 will use Tobradex with a regular concentration of BAK, Group 2 will use Dexathalm with a lower concentration of BAK, and Group 3 will use a version of Dexathalm without BAK. The effectiveness and impact of these treatments will be evaluated by measuring tear stability and assessing symptoms of dry eye through a questionnaire. Assessments take place before surgery and at several points after surgery (day 1, one week, and three weeks) to compare results and determine which treatment is gentlest and most effective on the eye surface.

Official TitleA Comparison Between the Ocular Surface of Different Concentrations of Benzalkonium Chloride Preservative in Postoperative Topical Medications After Cataract Surgery
NCT06404541
Principal SponsorKasr El Aini Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesLacrimal Apparatus DiseasesDry Eye Syndromes

Criteria

Inclusion Criteria: * Patients undergoing uncomplicated cataract surgery * Cataract grade: (LOCSIII): NO2NC2,C3,P2 Exclusion Criteria: Preoperative non-invasive TBUT\<10 seconds. Patients who have rheumatoid arthritis or autoimmune diseases affecting corneal surface. Involutional entropion or ectropion preoperative Postoperative significant corneal edema requiring medication.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
20 eyes received single dose unit Dexathalm containing: actives: In 1ml: Dexamethason 1mg and Netilimicin 3mg, without preservatives 5 times per day.

Group II

Active Comparator
20 eyes received regular Tobradex eye drops containing actives: In 1 ml: tobramycin 3 mg and dexamethasone 1 mg, preservative: 0.1mg of BAK per ml 5 times per day.

Group III

Active Comparator
20 eyes received Dexathalm multi-dose containing actives: In 1ml: Dexamethasone 1mg and Netilimicin 3mg, preservatives: 0.05mg of BAK per ml 5 times per day.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

KasrAl Ainy Hospital

Cairo, EgyptOpen KasrAl Ainy Hospital in Google Maps
SuspendedOne Study Center