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

Phase 4

Active, not recruiting

• Conditions: Dry Eye Syndromes; Ocular Surface Disease
• Interventions: Drug: Dexamethasone, tobramycin, netilimicin

• Registration Number: NCT06404541
• Lead Sponsor: Kasr El Aini Hospital

Brief 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.

Study Timeline

• Study Start: 2024-01-10
• Primary Completion: 2024-04-10
• Status Verified: 2024-05
• Study Completion: 2024-05
• Study First Submitted: 2024-05-05
• Study First Submitted QC: 2024-05-05
• Last Update Submitted: 2024-05-05
• Study First Posted: 2024-05-08
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Dexamethasone, tobramycin, netilimicin	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 C	Dexamethasone, tobramycin, netilimicin	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.
Group A	Dexamethasone, tobramycin, netilimicin	20 eyes received single dose unit Dexathalm containing: actives: In 1ml: Dexamethason 1mg and Netilimicin 3mg, without preservatives 5 times per day.

Primary Outcome Measures

Name	Time	Method
OSDI	preoperative and 1 month postoperative	ocular surface disease index
MG loss	preoperative and 1 month postoperative	meibomian gland loss
TMH	preoperative and 1 month postoperative	Tear meniscus Height
NBUT	preoperative and 1 month postoperative	non invasive tear break up time

Trial Locations

Locations (1)

KasrAl Ainy Hospital; 🇪🇬 Cairo, Giza, Egypt