Ocular Surface DiseasePhase 4NCT06404541
A Comparative Study Between Preservative With Benzalkonium Chloride vs Preservative Free Eye Drops on the Ocular Surface
A Phase 4 study testing Dexamethasone, tobramycin, netilimicin in people with Ocular Surface Disease and Dry Eye Syndromes, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
study the effect of different concentrations of benzalkonium chloride on the ocular surface of non-dry-eyed patients post cataract surgery. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ocular Surface Disease, Dry Eye Syndromes
- What is being tested?
- Dexamethasone, tobramycin, netilimicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2024to May 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing uncomplicated cataract surgery
- Cataract grade: (LOCSIII): NO2NC2,C3,P2
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- All patients will be examined at day1, 1 week and 3 week postoperative.
- At 3 weeks re-evaluate I. TBUT by non-invasive ocular surface analyzer II. OSDI by filling the questionnaire.
- Conditions
- Ocular Surface Disease, Dry Eye Syndromes
- Being tested
- Dexamethasone, tobramycin, netilimicin
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone, tobramycin, netilimicinDrug
Group A: Dexathalm single dose Group B: Tobradex Group C: Dexathalm multi-dose
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | 20 eyes received single dose unit Dexathalm containing: actives: In 1ml: Dexamethason 1mg and Netilimicin 3mg, without preservatives 5 times per day. Receives: Drug: Dexamethasone, tobramycin, netilimicin |
| Group B | Active comparator | 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. Receives: Drug: Dexamethasone, tobramycin, netilimicin |
| Group C | Active comparator | 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. Receives: Drug: Dexamethasone, tobramycin, netilimicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
NBUT
non invasive tear break up time
Measured: preoperative and 1 month postoperative
TMH
Tear meniscus Height
Measured: preoperative and 1 month postoperative
OSDI
ocular surface disease index
Measured: preoperative and 1 month postoperative
MG loss
meibomian gland loss
Measured: preoperative and 1 month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start10 Jan 2024
- Primary completion10 Apr 2024
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Surface DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amnah Ayman, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404541
- Sponsor's protocol ID
- MS-127-2023
- Status last verified
- May 2024
- First submitted
- 5 May 2024
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between the Ocular Surface of Different Concentrations of Benzalkonium Chloride Preservative in Postoperative Topical Medications After Cataract Surgery
- ClinicalTrials.gov ID
- NCT06404541
- Acronym / sponsor ID
- MS-127-2023
- Conditions
- Ocular Surface Disease, Dry Eye Syndromes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 10 Apr 2024 (actual)
- Study completion
- May 2024 (estimated)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- All patients will be examined at day1, 1 week and 3 week postoperative.
- At 3 weeks re-evaluate I. TBUT by non-invasive ocular surface analyzer II. OSDI by filling the questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Dexamethasone, tobramycin, netilimicin20 eyes received single dose unit Dexathalm containing: actives: In 1ml: Dexamethason 1mg and Netilimicin 3mg, without preservatives 5 times per day. |
| Group B | Active comparator | Drug: Dexamethasone, tobramycin, netilimicin20 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 comparator | Drug: Dexamethasone, tobramycin, netilimicin20 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing uncomplicated cataract surgery
- Cataract grade: (LOCSIII): NO2NC2,C3,P2
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone, tobramycin, netilimicinGroup A: Dexathalm single dose Group B: Tobradex Group C: Dexathalm multi-dose | Drug | Group A, Group B, Group C |
Primary outcome
NBUT
Time frame: preoperative and 1 month postoperative
non invasive tear break up time
TMH
Time frame: preoperative and 1 month postoperative
Tear meniscus Height
OSDI
Time frame: preoperative and 1 month postoperative
ocular surface disease index
MG loss
Time frame: preoperative and 1 month postoperative
meibomian gland loss
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone, tobramycin, netilimicin in people with Ocular Surface Disease and Dry Eye Syndromes, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NBUT (time frame: preoperative and 1 month postoperative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.