Uveitis, AnteriorPhase 4NCT05649111
A Study of the Effect of Different Doses of Difluprednate Eye Drops on the Intraocular Pressure After Phacoemulsification
A Phase 4 study testing Difluprednate Eye Drops in people with Uveitis, Anterior, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The study aims at detecting the minimum effective daily dose and duration of difluprednate that can be used to treat postoperative inflammation after phacoemulsification without increasing the intraocular pressure, and whether it can be safely given within the first 24 hours after the operation. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Uveitis, Anterior
- What is being tested?
- Difluprednate Eye Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 1 Feb 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-80
- Grade 1 to 4 nuclear cataract LOCS II
- Cumulative dissipated energy CDE 1 to 10
- Done by a single surgeon using the chopping technique
Who cannot join
- History of uveitis
- the use of topical or systemic steroids on the last post-operative day
- Intraoperative or postoperative complications
- Intraoperative iris manipulations or phaco traume
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kafrelsheikh University
Kafr ash Shaykh, 33516
Ahmed Hashem, +201003828881, ahmed_hashiem@med.kfs.edu.eg
About this study
The study aims at detecting the minimum effective daily dose and duration of difluprednate that can be used to treat postoperative inflammation after phacoemulsification without increasing the intraocular pressure, and whether it can be safely given within the first 24 hours after the operation.
Read the detailed description
Conventional phacoemulsification will be performed by the same surgeon for all the cases using the stop and chop technique. Anterior chamber examination for flare and cells using slit-lamp biomicroscopy according to the SUN recommendations and intraocular pressure measurement using Goldmann applanation tonometer will be done for all the cases before surgery and on the 1st, 3rd, 7th, 14th days as well as one month after the procedure.
All cases will receive Nepafenac 0.1% ( Nevanac 0.1%) 3 times per day on the last preoperative day, one tablet of Acetazolamide 250 mg (Cidamex 250mg) within the first 3 hours after the procedure and Moxifloxacin (Vigamox 0.5%) 0.1 ml intracameral and post-operative drops 3 times per day for 10 days and will be divided into:
In this pilot study:
- Group A : will receive Difluprednate 4 times per day for 1 week, then twice per day for 1 week and then once per day for 5 days starting 24 hours after the operation
- Group B : will receive Difluprednate 3 times per day for 4 days, then twice per day for 4 days and then once per day for 4 days starting 4 hours after the operation
- Conditions
- Uveitis, Anterior
- Being tested
- Difluprednate Eye Drops
- Medical subject headings
- Uveitis, Anterior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Difluprednate Eye DropsDrug
post-operative cataract surgery medication regimen. but different dosages between the 2 groups.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | will receive Difluprednate 4 times per day for 1 week, then twice per day for 1 week and then once per day for 5 days starting 24 hours after the operation Receives: Drug: Difluprednate Eye Drops |
| Group B | Active comparator | will receive Difluprednate 3 times per day for 4 days, then twice per day for 4 days and then once per day for 4 days starting 4 hours after the operation Receives: Drug: Difluprednate Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior chamber examination for flare and cell
using SUN classification
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start1 Nov 2022
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveitis, AnteriorStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- 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
- Model description
- * Group A (FDA dose): will receive Difluprednate 4 times per day for 1 week, then twice per day for 1 week and then once per day for 5 days starting 24 hours after the operation * Group B will receive Difluprednate 3 times per day for 4 days, then twice per day for 4 days and then once per day for 4 days starting 4 hours after the operation
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hashiem, Kafrelsheikh University
- Investigators
- Ahmed Hashem, PhD, Principal investigator, Kafrelsheikh university faculty of medicin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649111
- Sponsor's protocol ID
- 50-11-16
- Status last verified
- Dec 2022
- First submitted
- 25 Nov 2022
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Effect of Different Doses of Difluprednate Eye Drops on the Intraocular Pressure After Phacoemulsification
- ClinicalTrials.gov ID
- NCT05649111
- Acronym / sponsor ID
- 50-11-16
- Conditions
- Uveitis, Anterior
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 13 Dec 2022 (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.
The study aims at detecting the minimum effective daily dose and duration of difluprednate that can be used to treat postoperative inflammation after phacoemulsification without increasing the intraocular pressure, and whether it can be safely given within the first 24 hours after the operation.
Detailed description
Conventional phacoemulsification will be performed by the same surgeon for all the cases using the stop and chop technique. Anterior chamber examination for flare and cells using slit-lamp biomicroscopy according to the SUN recommendations and intraocular pressure measurement using Goldmann applanation tonometer will be done for all the cases before surgery and on the 1st, 3rd, 7th, 14th days as well as one month after the procedure.
All cases will receive Nepafenac 0.1% ( Nevanac 0.1%) 3 times per day on the last preoperative day, one tablet of Acetazolamide 250 mg (Cidamex 250mg) within the first 3 hours after the procedure and Moxifloxacin (Vigamox 0.5%) 0.1 ml intracameral and post-operative drops 3 times per day for 10 days and will be divided into:
In this pilot study:
- Group A : will receive Difluprednate 4 times per day for 1 week, then twice per day for 1 week and then once per day for 5 days starting 24 hours after the operation
- Group B : will receive Difluprednate 3 times per day for 4 days, then twice per day for 4 days and then once per day for 4 days starting 4 hours after the operation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- * Group A (FDA dose): will receive Difluprednate 4 times per day for 1 week, then twice per day for 1 week and then once per day for 5 days starting 24 hours after the operation * Group B will receive Difluprednate 3 times per day for 4 days, then twice per day for 4 days and then once per day for 4 days starting 4 hours after the operation
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Difluprednate Eye Dropswill receive Difluprednate 4 times per day for 1 week, then twice per day for 1 week and then once per day for 5 days starting 24 hours after the operation |
| Group B | Active comparator | Drug: Difluprednate Eye Dropswill receive Difluprednate 3 times per day for 4 days, then twice per day for 4 days and then once per day for 4 days starting 4 hours after the operation |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 40-80
- Grade 1 to 4 nuclear cataract LOCS II
- Cumulative dissipated energy CDE 1 to 10
- Done by a single surgeon using the chopping technique
Key exclusion criteria (4 listed)
- History of uveitis
- the use of topical or systemic steroids on the last post-operative day
- Intraoperative or postoperative complications
- Intraoperative iris manipulations or phaco traume
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 |
|---|---|---|
| Difluprednate Eye Dropspost-operative cataract surgery medication regimen. but different dosages between the 2 groups. | Drug | Group A, Group B |
Primary outcome
Anterior chamber examination for flare and cell
Time frame: 3 months
using SUN classification
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Individual participant dataSharing planned: No
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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.
Ahmed Hashem, PhD principal investigator
Kafrelsheikh university faculty of medicin
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 Difluprednate Eye Drops in people with Uveitis, Anterior, run by Kafrelsheikh University 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 4 inclusion and 4 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 13 Dec 2022. 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?
Contact Ahmed Hashem, PhD (+201003828881, ahmed_hashiem@med.kfs.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anterior chamber examination for flare and cell (time frame: 3 months). 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 13 Dec 2022.