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

NCT ID: NCT02825186

Last Updated: 2016-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2018-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Loteprendol

Topical Loteprendol used after strabismus surgery

Group Type: EXPERIMENTAL

Loteprendol etabonate 0.5%

Intervention Type: DRUG

Steroid eye drops used after strabismus surgery.

Dexamethasone

Topical Dexamethasone used after strabismus surgery

Group Type: EXPERIMENTAL

Dexamethasone 0.1%

Intervention Type: DRUG

Interventions

Loteprendol etabonate 0.5%

Steroid eye drops used after strabismus surgery.

Intervention Type: DRUG

Dexamethasone 0.1%

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

michal roll

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Ophthalmology, Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Countries

Israel

Facility Contacts

Gad Dotan, MD

Role: primary

gadd@tlvmc.gov.il

972-3-6974165

Keren Elia Ogalbo

Role: backup

kernel@tlvmc.gov.il

972-3-6974165

Other Identifiers

TLV-015-0185

Identifier Type: -

Identifier Source: org_study_id