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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06404541

Enrollment

Registered

2024-05-08

Start date

2024-01-10

Completion date

2024-05-31

Last updated

2024-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndromes, Ocular Surface Disease

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.

Interventions

DRUGDexamethasone, tobramycin, netilimicin

Group A: Dexathalm single dose Group B: Tobradex Group C: Dexathalm multi-dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026