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Intraocular Pressure With Loteprednol and Dexamethasone

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00781300
First received: October 27, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

The purpose of this study is to compare intraocular pressure (IOP) changes after pterygium surgery among patients using loteprednol and dexamethasone during the postoperative period.


Condition Intervention Phase
Glaucoma, Open-Angle
Ocular Hypertension
 Drug: Loteprednol Etabonate 0.5%
Drug: Dexamethasone 0.1%
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial Comparing the Intraocular Pressure Changes With the Use of Loteprednol and Dexamethasone After Pterygium Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Intraocular Pressure (IOP) [ Time Frame: Once a week for the first 4 weeks and 6 weeks after the procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • IOP difference between the operated eye and the fellow eye [ Time Frame: Once a week for the first 4 weeks and then 6 weeks after the procedure ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: March 2006
Study Completion Date: February 2007
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Loteprednol Drug: Loteprednol Etabonate 0.5%
Patients in the Loteprednol Group received Loteprednol Etabonate 0.5% associated with Tobramycin 0.3% in separate eyedrops for four weeks: 6 times a day during the first postoperative week, 4 times a day during the second week, 3 times a day during the third week and twice-daily during the fourth week
Other Names:
  • Loteprol
  • Lotemax
Active Comparator: Dexamethasone Drug: Dexamethasone 0.1%
The patients in Dexamethasone Group received Dexamethasone 0.1% associated with Tobramycin 0.3% in a single eyedrop for four weeks: 6 times a day during the first postoperative week, 4 times a day during the second week, 3 times a day during the third week and twice-daily during the fourth week.
Other Name: Tobradex

Detailed Description:

Surgical management of pterygium is known to initiate an inflammatory process with different levels of intensity. Corticosteroids are anti-inflammatory agents used to reduce the inflammatory process observed after surgical interventions including after pterygium surgery. However, use of topical corticosteroids can induce an elevation in intraocular pressure (IOP) due to a reduction in the facility of aqueous outflow.

Loteprednol etabonate (LE) was designed to maintain the anti-inflammatory efficiency of corticosteroids while lowering the risk of inducing IOP elevation. LE showed less effect on IOP than Prednisolone Acetate. This probably occurs due to lower levels of LE in the aqueous humor.

Some trials compare LE to other corticosteroids or placebo in treatments of the anterior uveitis, allergic conjunctivitis and cataract surgery. To our knowledge, there are no trials studying the effect of LE on IOP after pterygium surgery.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age: eighteen years old or more
  • IOP: less than 22mmHg

Exclusion Criteria:

  • History of previous ocular surgery
  • Use of topical or systemic corticosteroids for up to a month before the surgery
  • Extensive pterygia that disabled accurate IOP measurement
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781300

Locations
Brazil
Department of Opthalmology, Federal University of São Paulo
São Paulo, SP, Brazil, 04023-062
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Luciano M Pinto, MD Fedreal University of São Paulo
  More Information

No publications provided

Responsible Party: Luciano Moreira Pinto, MD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT00781300     History of Changes
Other Study ID Numbers: CEP 1104/03
Study First Received: October 27, 2008
Last Updated: October 27, 2008
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Federal University of São Paulo:
Intraocular pressure
Pterygium
Surgery
Steroids
Glaucoma

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Loteprednol etabonate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
 Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents

ClinicalTrials.gov processed this record on June 17, 2013