Intraocular PressurePhase 4NCT02816905
Ocular-hypertensive Response to Topical Steroids in Children After Bilateral Strabismus Surgery
A Phase 4 study testing 0.1 % Dexamethasone, 0.1% Fluorometholone and 1% Rimexolone in people with Intraocular Pressure, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to compare the effects of topical (Rimexolone versus Dexamethasone) on the IOP in children under 13 years of age who underwent bilateral strabismus surgery, and to compare the effects of topical (Rimexolone versus Fluorometholone) on the IOP in the children under 13 years of age who underwent bilateral… Read more about this study
- Who is it for?
- Ages Up to 13 years
- Conditions the study is for
- Intraocular Pressure
- What is being tested?
- 0.1 % Dexamethasone, 0.1% Fluorometholone and 1% Rimexolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2015to Jun 2016
- 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 Up to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children younger than 13 years of age.
- Children who underwent bilateral recession strabismus surgeries.
- Preoperative IOP of 21.00 mmHg or less, with a cup-disc ratio of 0.3 or less.
- The absence of systemic disease and ocular disease (apart from strabismus) in both eyes.
- Children who can comply with the IOP measurements using the Tono-Pen®, as no type of anesthesia will be used, except for the topical anesthesia.
Who cannot join
- Patients that are 13 years of age or older.
- Children who need resection muscle surgeries, surgeries for the vertical, or the oblique muscles.
- Preoperative IOP of more than 21.00 mmHg, or a cup-disc ratio of more than 0.3
- Family history of glaucoma or high myopia.
- A history of steroid usage in the past year.
- Failure to comply with IOP measurements or the follow-up schedule.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ocular-hypertensive Response to Topical Steroids in Children After Bilateral Strabismus Surgery (Topical Rimexolone Versus Topical Dexamethasone and Topical Fluorometholone)
This study aims to compare the effects of topical (Rimexolone versus Dexamethasone) on the IOP in children under 13 years of age who underwent bilateral strabismus surgery, and to compare the effects of topical (Rimexolone versus Fluorometholone) on the IOP in the children under 13 years of age who underwent bilateral strabismus surgery.
Read the detailed description
Children under the age of 13 years undergoing bilateral strabismus surgery in Cairo University Hospitals (Cairo University Specialized Pediatric Hospital and Kasr Al Ainy Hospital). will be randomized using simple randomization method, computer software for randomization, into two equal groups:
- First group: One eye is randomized to receive topical 0.1% Dexamethasone, whereas the fellow eye will receive topical 1% Rimexolone four times per day for 2 weeks.
- Second group: One eye is randomized to receive topical 0.1% Fluorometholone, whereas the fellow eye will receive topical 1% Rimexolone four times per day for 2 weeks.
IOP will be measured on the day before operation using the Tono-Pen®. Three reliable measurements will be obtained from each eye and the mean will be taken.
IOP will be measured at postoperative weeks 1, 2, 3, 4 and 6 using the Tono-Pen®.
- Conditions
- Intraocular Pressure
- Being tested
- 0.1 % Dexamethasone, 0.1% Fluorometholone, 1% Rimexolone
- Keywords
- intraocular pressure, topical steroids, strabismus
- Medical subject headings
- Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.1 % DexamethasoneDrug
Also called Topical steroid
20 eyes are randomized to receive topical 0.1% Dexamethasone four times per day for 2 weeks.
0.1% FluorometholoneDrug
Also called Topical steroid
20 eyes are randomized to receive topical 0.1% Fluorometholone four times per day for 2 weeks.
1% RimexoloneDrug
Also called Topical steroid
40 eyes are randomized to receive topical 1% Rimexolone four times per day for 2 weeks. 20 of these eyes were the contralateral eyes of the patients who received 0.1% Dexamethasone in their first eye. The other 20 eyes were the contralateral eyes of the patients who received 0.1% Fluorometholone in their first eye
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | 20 eyes that received topical 0.1% Dexamethasone 4 times per day for 2 weeks after surgery. And topical Moxifloxacin 4 times per day for 2 weeks after surgery. Receives: Drug: 0.1 % Dexamethasone |
| Group B | Active comparator | 20 eyes that received topical 0.1 % Fluorometholone 4 times per day for 2 weeks after surgery. And topical Moxifloxacin 4 times per day for 2 weeks after surgery. Receives: Drug: 0.1% Fluorometholone |
| Group C | Active comparator | 40 eyes that received topical 1% Rimexolone 4 times per day for 2 weeks after surgery. And topical Moxifloxacin 4 times per day for 2 weeks after surgery. Receives: Drug: 1% Rimexolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the rise in intraocular pressure using the Tono-Pen® after topical steroids are used in children under 12 years of age, who underwent bilateral strabismus surgery
Measuring the rise in intraocular pressure using the Tono-Pen® after topical steroid use in children. IOP will be measured at postoperative weeks 1, 2, 3, 4 and 6. And will be compared with pre-operative values.
Measured: IOP will be followed up for 6 weeks after initial use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startOct 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular PressureStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Tawfik Al Hanaineh, Cairo University
- Investigators
- Omar M. El Shafie El Zawahry, PhD, Study chair, Cairo University Hospital- Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816905
- Sponsor's protocol ID
- Abeer Al Hanaineh
- Status last verified
- Jun 2016
- First submitted
- 26 Jun 2016
- Last updated
- 29 Jun 2016
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular-hypertensive Response to Topical Steroids in Children After Bilateral Strabismus Surgery (Topical Rimexolone Versus Topical Dexamethasone and Topical Fluorometholone)
- ClinicalTrials.gov ID
- NCT02816905
- Acronym / sponsor ID
- Abeer Al Hanaineh
- Conditions
- Intraocular Pressure
- Keywords
- intraocular pressure, topical steroids, strabismus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 29 Jun 2016 (estimated)
- 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.
This study aims to compare the effects of topical (Rimexolone versus Dexamethasone) on the IOP in children under 13 years of age who underwent bilateral strabismus surgery, and to compare the effects of topical (Rimexolone versus Fluorometholone) on the IOP in the children under 13 years of age who underwent bilateral strabismus surgery.
Detailed description
Children under the age of 13 years undergoing bilateral strabismus surgery in Cairo University Hospitals (Cairo University Specialized Pediatric Hospital and Kasr Al Ainy Hospital). will be randomized using simple randomization method, computer software for randomization, into two equal groups:
- First group: One eye is randomized to receive topical 0.1% Dexamethasone, whereas the fellow eye will receive topical 1% Rimexolone four times per day for 2 weeks.
- Second group: One eye is randomized to receive topical 0.1% Fluorometholone, whereas the fellow eye will receive topical 1% Rimexolone four times per day for 2 weeks.
IOP will be measured on the day before operation using the Tono-Pen®. Three reliable measurements will be obtained from each eye and the mean will be taken.
IOP will be measured at postoperative weeks 1, 2, 3, 4 and 6 using the Tono-Pen®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: 0.1 % Dexamethasone20 eyes that received topical 0.1% Dexamethasone 4 times per day for 2 weeks after surgery. And topical Moxifloxacin 4 times per day for 2 weeks after surgery. |
| Group B | Active comparator | Drug: 0.1% Fluorometholone20 eyes that received topical 0.1 % Fluorometholone 4 times per day for 2 weeks after surgery. And topical Moxifloxacin 4 times per day for 2 weeks after surgery. |
| Group C | Active comparator | Drug: 1% Rimexolone40 eyes that received topical 1% Rimexolone 4 times per day for 2 weeks after surgery. And topical Moxifloxacin 4 times per day for 2 weeks after surgery. |
Who may qualify
- Ages
- Up to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children younger than 13 years of age.
- Children who underwent bilateral recession strabismus surgeries.
- Preoperative IOP of 21.00 mmHg or less, with a cup-disc ratio of 0.3 or less.
- The absence of systemic disease and ocular disease (apart from strabismus) in both eyes.
- Children who can comply with the IOP measurements using the Tono-Pen®, as no type of anesthesia will be used, except for the topical anesthesia.
Key exclusion criteria (6 listed)
- Patients that are 13 years of age or older.
- Children who need resection muscle surgeries, surgeries for the vertical, or the oblique muscles.
- Preoperative IOP of more than 21.00 mmHg, or a cup-disc ratio of more than 0.3
- Family history of glaucoma or high myopia.
- A history of steroid usage in the past year.
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 |
|---|---|---|
| 0.1 % DexamethasoneAlso: Topical steroid20 eyes are randomized to receive topical 0.1% Dexamethasone four times per day for 2 weeks. | Drug | Group A |
| 0.1% FluorometholoneAlso: Topical steroid20 eyes are randomized to receive topical 0.1% Fluorometholone four times per day for 2 weeks. | Drug | Group B |
| 1% RimexoloneAlso: Topical steroid40 eyes are randomized to receive topical 1% Rimexolone four times per day for 2 weeks. 20 of these eyes were the contralateral eyes of the patients who received 0.1% Dexamethasone in their first eye. The other 20 eyes were the contralateral eyes of the patients who received 0.1% Fluorometholone in their first eye | Drug | Group C |
Primary outcome
Measuring the rise in intraocular pressure using the Tono-Pen® after topical steroids are used in children under 12 years of age, who underwent bilateral strabismus surgery
Time frame: IOP will be followed up for 6 weeks after initial use
Measuring the rise in intraocular pressure using the Tono-Pen® after topical steroid use in children. IOP will be measured at postoperative weeks 1, 2, 3, 4 and 6. And will be compared with pre-operative values.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
- Individual participant dataSharing planned: Undecided
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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.
Omar M. El Shafie El Zawahry, PhD study chair
Cairo University Hospital- Department of Ophthalmology
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 0.1 % Dexamethasone, 0.1% Fluorometholone and 1% Rimexolone in people with Intraocular Pressure, run by Cairo 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 29 Jun 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measuring the rise in intraocular pressure using the Tono-Pen® after topical steroids are used in children under 12 years of age, who underwent bilateral strabismus surgery (time frame: IOP will be followed up for 6 weeks after initial use). 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 29 Jun 2016.