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
1 other identifier
interventional
60
1 country
1
Brief Summary
study the effect of different concentrations of benzalkonium chloride on the ocular surface of non-dry-eyed patients post cataract surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2024
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedFirst Submitted
Initial submission to the registry
May 5, 2024
CompletedFirst Posted
Study publicly available on registry
May 8, 2024
CompletedMay 8, 2024
May 1, 2024
3 months
May 5, 2024
May 5, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
NBUT
non invasive tear break up time
preoperative and 1 month postoperative
TMH
Tear meniscus Height
preoperative and 1 month postoperative
OSDI
ocular surface disease index
preoperative and 1 month postoperative
MG loss
meibomian gland loss
preoperative and 1 month postoperative
Study Arms (3)
Group A
ACTIVE COMPARATOR20 eyes received single dose unit Dexathalm containing: actives: In 1ml: Dexamethason 1mg and Netilimicin 3mg, without preservatives 5 times per day.
Group B
ACTIVE COMPARATOR20 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
ACTIVE COMPARATOR20 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.
Interventions
Group A: Dexathalm single dose Group B: Tobradex Group C: Dexathalm multi-dose
Eligibility Criteria
You may qualify if:
- Patients undergoing uncomplicated cataract surgery
- Cataract grade: (LOCSIII): NO2NC2,C3,P2
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
KasrAl Ainy Hospital
Cairo, Giza Governorate, 11956, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- AAyman
Study Record Dates
First Submitted
May 5, 2024
First Posted
May 8, 2024
Study Start
January 10, 2024
Primary Completion
April 10, 2024
Study Completion
May 1, 2024
Last Updated
May 8, 2024
Record last verified: 2024-05