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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
michal roll, Tel-Aviv Sourasky Medical Center

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.

Condition or disease Intervention/treatment Phase
Ophthalmology Drug: Loteprendol etabonate 0.5% Drug: Dexamethasone 0.1% Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Study Start Date : July 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Loteprendol
Topical Loteprendol used after strabismus surgery
Drug: Loteprendol etabonate 0.5%
Steroid eye drops used after strabismus surgery.

Experimental: Dexamethasone
Topical Dexamethasone used after strabismus surgery
Drug: Dexamethasone 0.1%

Primary Outcome Measures :
  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.

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02825186

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Department of Ophthalmology, Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Contact: Gad Dotan, MD    972-3-6974165   
Contact: Keren Elia Ogalbo    972-3-6974165   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
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Responsible Party: michal roll, MD, Tel-Aviv Sourasky Medical Center Identifier: NCT02825186    
Other Study ID Numbers: TLV-015-0185
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: July 7, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents