Ophthalmology Clinical Trial
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.
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:
1. Patient pain and discomfort
2. Conjunctival chemosis
3. Conjunctival hyperaemia
4. Conjunctival discharge
5. Conjunctival gap
6. Intraocular pressure (IOP)
7. Number of pain control medications taken
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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