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

May 5, 2024 updated by: Amnah Ayman, Kasr El Aini Hospital

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Giza
      • Cairo, Giza, Egypt, 11956
        • KasrAl Ainy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
20 eyes received single dose unit Dexathalm containing: actives: In 1ml: Dexamethason 1mg and Netilimicin 3mg, without preservatives 5 times per day.
Drug: Dexamethasone, tobramycin, netilimicin
Group A: Dexathalm single dose Group B: Tobradex Group C: Dexathalm multi-dose
Active Comparator: Group B
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.
Drug: Dexamethasone, tobramycin, netilimicin
Group A: Dexathalm single dose Group B: Tobradex Group C: Dexathalm multi-dose
Active Comparator: Group C
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.
Drug: Dexamethasone, tobramycin, netilimicin
Group A: Dexathalm single dose Group B: Tobradex Group C: Dexathalm multi-dose

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2024

Primary Completion (Actual)

April 10, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

May 5, 2024

First Submitted That Met QC Criteria

May 5, 2024

First Posted (Actual)

May 8, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 5, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-127-2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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