A Comparative Study Between Preservative With Benzalkonium Chloride vs Preservative Free Eye Drops on the Ocular Surface
NCT ID: NCT06404541
Last Updated: 2024-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
60 participants
INTERVENTIONAL
2024-01-10
2024-05-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group A
20 eyes received single dose unit Dexathalm containing: actives: In 1ml: Dexamethason 1mg and Netilimicin 3mg, without preservatives 5 times per day.
Dexamethasone, tobramycin, netilimicin
Group A: Dexathalm single dose Group B: Tobradex Group C: Dexathalm multi-dose
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.
Dexamethasone, tobramycin, netilimicin
Group A: Dexathalm single dose Group B: Tobradex Group C: Dexathalm multi-dose
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.
Dexamethasone, tobramycin, netilimicin
Group A: Dexathalm single dose Group B: Tobradex Group C: Dexathalm multi-dose
Interventions
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Dexamethasone, tobramycin, netilimicin
Group A: Dexathalm single dose Group B: Tobradex Group C: Dexathalm multi-dose
Eligibility Criteria
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Inclusion Criteria
* Cataract grade: (LOCSIII): NO2NC2,C3,P2
Exclusion Criteria
Involutional entropion or ectropion preoperative Postoperative significant corneal edema requiring medication.
40 Years
70 Years
ALL
Yes
Sponsors
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Kasr El Aini Hospital
OTHER
Responsible Party
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Amnah Ayman
AAyman
Locations
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KasrAl Ainy Hospital
Cairo, Giza Governorate, Egypt
Countries
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Other Identifiers
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MS-127-2023
Identifier Type: -
Identifier Source: org_study_id
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