OphthalmologyNCT02825186
Dexamethasone (Sterodex) Versus Loteprendol (Lotemax) Eye Drops Following Strabismus Surgery
A study testing Loteprendol etabonate 0.5% and Dexamethasone 0.1% in people with Ophthalmology, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to compare the efficacy and side effects of topical Loteprendol etabonate 0.5% (Lotemax) versus Dexamethasone 0.1% (Sterodex) following strabismus surgery. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Ophthalmology
- What is being tested?
- Loteprendol etabonate 0.5% and Dexamethasone 0.1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2016to Jun 2018
- Phase
- Interventional
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing recession strabismus surgery through a fornix approach of one of the horizontal recti muscles (either medial rectus or lateral rectus) or of the inferior oblique muscle
- Must be able to comply with topical treatment
- Must be able to comply with post-operative appointment schedule.
Who cannot join
- Previous ocular surgery (including previous strabismus surgery)
- Ocular pathology
- Family history of glaucoma
- Personal history of allergic drug reaction or allergic conjunctivitis
- More than one muscle operated on
- Adjustable sutures technique
- Patients in whom it is impossible to measure IOP before surgery
Trial locations and contacts
1 site in 1 country.
Israel1 site
Department of Ophthalmology, Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Gad Dotan, MD, 972-3-6974165, gadd@tlvmc.gov.il
Keren Elia Ogalbo, 972-3-6974165, kernel@tlvmc.gov.il
About this study
The purpose of this study is to compare the efficacy and side effects of topical Loteprendol etabonate 0.5% (Lotemax) versus Dexamethasone 0.1% (Sterodex) following strabismus surgery.
Read the detailed description
This is a randomized prospective study that will involve 100 patients (males and females) undergoing strabismus surgery. All patients will be randomly assigned to receive one of the study drugs (Loteprendol etabonate 0.5% (Lotemax) drops or Dexamethasone 0.1% (Sterodex) drops) after undergoing strabismus surgery. In addition to the study drug all patients (in both groups) will receive topical Ofloxacin 0.3% (Oflox) eye drops. All patients will undergo a complete ophthalmological evaluation before surgery including orthoptic assessment of their strabismus and measurement of intraocular pressure (IOP). Topical treatment with the study drug and topical Ofloxacin 0.3% (Oflox) eye drops will begin on the evening of the surgery, following a schedule that will be the same for both groups: 4 times daily during the first week, 3 times daily for the second group, twice daily for the third week, and as needed for the fourth week. All patients will be examined at 1 day, 1 week, 2 weeks and 4 weeks after surgery by a masked investigator (not the strabismus surgeon).
The parameters to be checked will include:
- Patient pain and discomfort
- Conjunctival chemosis
- Conjunctival hyperaemia
- Conjunctival discharge
- Conjunctival gap
- Intraocular pressure (IOP)
- Number of pain control medications taken
- Conditions
- Ophthalmology
- Being tested
- Loteprendol etabonate 0.5%, Dexamethasone 0.1%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loteprendol etabonate 0.5%Drug
Steroid eye drops used after strabismus surgery.
Dexamethasone 0.1%Drug
| Study group | Role | What they receive |
|---|---|---|
| Loteprendol | Experimental | Topical Loteprendol used after strabismus surgery Receives: Drug: Loteprendol etabonate 0.5% |
| Dexamethasone | Experimental | Topical Dexamethasone used after strabismus surgery Receives: Drug: Dexamethasone 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline - Intraocular pressure (IOP)
IOP will be measured by Goldmann applantation tonometry one day before surgery (baseline IOP). In patients in whom Goldmann tonometry is impossible, ICARE tonometer will be used instead. IOP will be measured 1 day, 1 week, 2 weeks, 4 weeks after surgery, at each time point change from baseline IOP will be recorded.
Measured: 1 day before surgery (basline), and 1 day, 1 week, 2 weeks, 4 weeks after surgery
Change from baseline - Conjunctival hyperemia
Conjunctival hyepremia will be measured one day before surgery (basline measurement) using the following scale: 0=no hyperemia, 1=mild (less than one quadrant), 2=moderate (less than half of the conjunctival surface), 3= severe (less than half of the conjunctival surface). Conjunctival hyperemia will be measured 1 day, 1 week, 2 weeks, 4 weeks after surgery, at each time point change from baseline measurement will be recorded.
Measured: 1 day before surgery (basline), and 1 day, 1 week, 2 weeks, 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OphthalmologyStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, michal roll, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825186
- Sponsor's protocol ID
- TLV-015-0185
- Status last verified
- Jul 2016
- First submitted
- 22 May 2016
- Last updated
- 7 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone (Sterodex) Versus Loteprendol (Lotemax) Eye Drops Following Strabismus Surgery
- ClinicalTrials.gov ID
- NCT02825186
- Acronym / sponsor ID
- TLV-015-0185
- Conditions
- Ophthalmology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jul 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 7 Jul 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.
The purpose of this study is to compare the efficacy and side effects of topical Loteprendol etabonate 0.5% (Lotemax) versus Dexamethasone 0.1% (Sterodex) following strabismus surgery.
Detailed description
This is a randomized prospective study that will involve 100 patients (males and females) undergoing strabismus surgery. All patients will be randomly assigned to receive one of the study drugs (Loteprendol etabonate 0.5% (Lotemax) drops or Dexamethasone 0.1% (Sterodex) drops) after undergoing strabismus surgery. In addition to the study drug all patients (in both groups) will receive topical Ofloxacin 0.3% (Oflox) eye drops. All patients will undergo a complete ophthalmological evaluation before surgery including orthoptic assessment of their strabismus and measurement of intraocular pressure (IOP). Topical treatment with the study drug and topical Ofloxacin 0.3% (Oflox) eye drops will begin on the evening of the surgery, following a schedule that will be the same for both groups: 4 times daily during the first week, 3 times daily for the second group, twice daily for the third week, and as needed for the fourth week. All patients will be examined at 1 day, 1 week, 2 weeks and 4 weeks after surgery by a masked investigator (not the strabismus surgeon).
The parameters to be checked will include:
- Patient pain and discomfort
- Conjunctival chemosis
- Conjunctival hyperaemia
- Conjunctival discharge
- Conjunctival gap
- Intraocular pressure (IOP)
- Number of pain control medications taken
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loteprendol | Experimental | Drug: Loteprendol etabonate 0.5%Topical Loteprendol used after strabismus surgery |
| Dexamethasone | Experimental | Drug: Dexamethasone 0.1%Topical Dexamethasone used after strabismus surgery |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing recession strabismus surgery through a fornix approach of one of the horizontal recti muscles (either medial rectus or lateral rectus) or of the inferior oblique muscle
- Must be able to comply with topical treatment
- Must be able to comply with post-operative appointment schedule.
Key exclusion criteria (7 listed)
- Previous ocular surgery (including previous strabismus surgery)
- Ocular pathology
- Family history of glaucoma
- Personal history of allergic drug reaction or allergic conjunctivitis
- More than one muscle operated on
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 |
|---|---|---|
| Loteprendol etabonate 0.5%Steroid eye drops used after strabismus surgery. | Drug | Loteprendol |
| Dexamethasone 0.1% | Drug | Dexamethasone |
Primary outcome
Change from baseline - Intraocular pressure (IOP)
Time frame: 1 day before surgery (basline), and 1 day, 1 week, 2 weeks, 4 weeks after surgery
IOP will be measured by Goldmann applantation tonometry one day before surgery (baseline IOP). In patients in whom Goldmann tonometry is impossible, ICARE tonometer will be used instead. IOP will be measured 1 day, 1 week, 2 weeks, 4 weeks after surgery, at each time point change from baseline IOP will be recorded.
Change from baseline - Conjunctival hyperemia
Time frame: 1 day before surgery (basline), and 1 day, 1 week, 2 weeks, 4 weeks after surgery
Conjunctival hyepremia will be measured one day before surgery (basline measurement) using the following scale: 0=no hyperemia, 1=mild (less than one quadrant), 2=moderate (less than half of the conjunctival surface), 3= severe (less than half of the conjunctival surface). Conjunctival hyperemia will be measured 1 day, 1 week, 2 weeks, 4 weeks after surgery, at each time point change from baseline measurement will be recorded.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
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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.
Department of Ophthalmology, Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Loteprendol etabonate 0.5% and Dexamethasone 0.1% in people with Ophthalmology, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 3 inclusion and 7 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 7 Jul 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 Israel. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline - Intraocular pressure (IOP) (time frame: 1 day before surgery (basline), and 1 day, 1 week, 2 weeks, 4 weeks after surgery). The study lists 2 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 7 Jul 2016; AzTrials last refreshed its copy on 8 Nov 2026.