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

NCT02825186 | Unknown

• 1 other identifier: TLV-015-0185
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ophthalmology

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  1 day before surgery (basline), and 1 day, 1 week, 2 weeks, 4 weeks after surgery

Study Arms (2)

Loteprendol

EXPERIMENTAL

Topical Loteprendol used after strabismus surgery

Drug: Loteprendol etabonate 0.5%

Dexamethasone

EXPERIMENTAL

Topical Dexamethasone used after strabismus surgery

Drug: Dexamethasone 0.1%

Interventions

Loteprendol etabonate 0.5% DRUG

Steroid eye drops used after strabismus surgery.

Loteprendol

Dexamethasone 0.1% DRUG

Dexamethasone

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Department of Ophthalmology, Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 22, 2016
• First Posted: July 7, 2016
• Study Start: July 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: July 7, 2016

Record last verified: 2016-07

Locations

IL (1)