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

Kasr El Aini Hospital

Status and phase: Active, not recruiting; Phase 4

Conditions: Dry Eye Syndromes; Ocular Surface Disease

Treatments: Drug: Dexamethasone, tobramycin, netilimicin

Study type: Interventional

Funder types: Other

Identifiers

NCT06404541

MS-127-2023

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Group A

Active Comparator group

Description:

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

Treatment:

Drug: Dexamethasone, tobramycin, netilimicin

Group B

Active Comparator group

Description:

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.

Treatment:

Drug: Dexamethasone, tobramycin, netilimicin

Group C

Active Comparator group

Description:

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.

Treatment:

Drug: Dexamethasone, tobramycin, netilimicin