Dexamethasone (Sterodex) Versus Loteprendol (Lotemax) Eye Drops Following Strabismus Surgery
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|ClinicalTrials.gov Identifier: NCT02825186|
Recruitment Status : Unknown
Verified July 2016 by michal roll, Tel-Aviv Sourasky Medical Center.
Recruitment status was: Not yet recruiting
First Posted : July 7, 2016
Last Update Posted : July 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Ophthalmology||Drug: Loteprendol etabonate 0.5% Drug: Dexamethasone 0.1%||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Topical Loteprendol used after strabismus surgery
Drug: Loteprendol etabonate 0.5%
Steroid eye drops used after strabismus surgery.
Topical Dexamethasone used after strabismus surgery
Drug: Dexamethasone 0.1%
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825186