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The Effect of Intravenous Glucocorticoids on the Tearfilm in Eyes With Thyroid-associated Ophthalmopathy

This study is not yet open for participant recruitment.
Verified April 2012 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01579539
First received: April 13, 2012
Last updated: April 16, 2012
Last verified: April 2012
History of Changes
  Purpose

Thyroid-associated ophthalmopathy (TAO), also called Graves' ophthalmopathy or thyroid eye disease, is a common orbital disease in adults. Patients with TAO, especially in its active phase, often complain about symptoms of ocular surface discomfort, including excess tearing, gritty sensation, increased sensitivity to light and foreign-body sensation, which are similar to inflammatory ocular surface disorders such as dry-eye syndrome (DES). Incomplete blink, increased proptosis and greater palpebral fissure width in TAO accelerates tear evaporation, which increases the tear fluid's osmolarity, and results in ocular surface damage. The administration of intravenous glucocorticoids can be an effective treatment for TAO.

The rationale of the present study is to assess the effect of intravenously administered glucocorticoids on the signs of DES in patients with TAO with new methods such as measurement of tear film thickness, tear film osmolarity and scattering of the tear film and well established methods for assessment of the severity of DES. Additionally, impression cytology and determination of tear cytokines/chemokines will be performed to obtain information about inflammatory processes on the ocular surface.


Condition Intervention Phase
Thyroid-associated Ophthalmopathy
Dry Eye Syndrome
 Drug: Methylprednisolone
Drug: Esomeprazole
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Intravenous Glucocorticoids on the Tearfilm in Eyes With Thyroid-associated Ophthalmopathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Tear film thickness as measured with OCT [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
    Measurements of tear film thickness with OCT will be performed 7 or less days before start of treatment, 6 weeks after start of treatment and 12 weeks after start of treatment


Secondary Outcome Measures:
  • Break up time (BUT) [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • Visual acuity [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • Tear film osmolarity [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • Degree of exophthalmia [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
    Hertel exophthalmometry

  • Palpebral fissure width [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • OSI (Objective Scattering Index) [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • Tear cytokines/chemokines [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • Impression cytology [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • Staining of the cornea with fluorescein [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • Schirmer I test [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • Subjective symptoms of dry eye syndrome [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: July 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients
Patients with moderate to severe thyroid-associated ophthalmopathy
 Drug: Methylprednisolone
500mg i.v. infusion once a week for 6 weeks followed by 250mg i.v. infusion once a week for 6 weeks
Drug: Esomeprazole
40mg i.v. infusion once a week for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women aged over 18 years
  • Active thyroid associated ophthalmopathy with clinical activity score (CAS) of each eye more than 3 or recently experienced worsening of proptosis, lid retraction, or ocular motility disturbance.
  • Normal ophthalmic findings except symptoms associated with TAO
  • Scheduled for treatment with systemic glucocorticoids according to the kahaly-scheme

Exclusion Criteria:

  • Chronic inactive TAO
  • Previous treatment with oral or intravenous glucocorticoids 3 months preceding the study
  • Participation in a clinical trial in the 3 weeks before the screening visit
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • Presence or history of a severe medical condition that will interfere with the study aim as judged by the clinical investigator
  • Wearing of contact lenses
  • Intake of dietary supplements in the 3 months preceding the study
  • Topical treatment with any ophthalmic drug in the 4 weeks preceding the study except topical lubricants
  • Ocular infection
  • Ocular surgery in the 3 months preceding the study
  • Sjögren's syndrome
  • Stevens-Johnson syndrome
  • Pregnancy, planned pregnancy or lactating
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01579539

Contacts
Contact: Gerhard Garhoefer, MD +43140400 ext 2981 gerhard.garhoefer@meduniwien.ac.at

Locations
Austria
Department of Clinical Pharmacology, Medical University of Vienna Not yet recruiting
Vienna, Austria, 1090
Contact: Gerhard Garhoefer, MD     +43140400 ext 2981     gerhard.garhoefer@meduniwien.ac.at    
Principal Investigator: Gerhard Garhoefer, MD            
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Gerhard Garhoefer, MD Department of Clinical Pharmacology, Medical University of Vienna
  More Information

No publications provided

Responsible Party: Gerhard Garhofer, Ass. Prof. PD. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01579539     History of Changes
Other Study ID Numbers: OPHT-120312
Study First Received: April 13, 2012
Last Updated: April 16, 2012
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
Methylprednisolone
Dry Eye Syndrome
Tear Film
Thyroid-associated ophthalmopathy

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases
Thyroid Diseases
Graves Ophthalmopathy
Lacrimal Apparatus Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Endocrine System Diseases
Eye Diseases, Hereditary
Graves Disease
Exophthalmos
 Orbital Diseases
Goiter
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases
Glucocorticoids
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Methylprednisolone acetate
Prednisolone acetate
Omeprazole
Hormones

ClinicalTrials.gov processed this record on May 23, 2013