NCT02825186

Dexamethasone (Sterodex) Versus Loteprendol (Lotemax) Eye Drops Following Strabismus Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

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.

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: 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

Conditions

• Ophthalmology

Interventions

Type	Name	Description
DRUG	Loteprendol etabonate 0.5%	Steroid eye drops used after strabismus surgery.
DRUG	Dexamethasone 0.1%

Timeline

• Start date: 2016-07-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2016-07-07
• Last updated: 2016-07-07

Locations

1 site across 1 country: Israel