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Trial record 1 of 1 for:    NCT01579539
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The Effect of Intravenous Glucocorticoids on the Tearfilm in Eyes With Thyroid-associated Ophthalmopathy

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ClinicalTrials.gov Identifier: NCT01579539
Recruitment Status : Completed
First Posted : April 18, 2012
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Thyroid-associated Ophthalmopathy Dry Eye Syndrome Drug: Methylprednisolone Drug: Esomeprazole Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Intravenous Glucocorticoids on the Tearfilm in Eyes With Thyroid-associated Ophthalmopathy
Actual Study Start Date : June 27, 2013
Actual Primary Completion Date : May 18, 2017
Actual Study Completion Date : May 18, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Tear film thickness as measured with OCT [ Time Frame: 13 weeks ]
    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 :
  1. Break up time (BUT) [ Time Frame: 13 weeks ]
  2. Visual acuity [ Time Frame: 13 weeks ]
  3. Tear film osmolarity [ Time Frame: 13 weeks ]
  4. Degree of exophthalmia [ Time Frame: 13 weeks ]
    Hertel exophthalmometry

  5. Palpebral fissure width [ Time Frame: 13 weeks ]
  6. OSI (Objective Scattering Index) [ Time Frame: 13 weeks ]
  7. Tear cytokines/chemokines [ Time Frame: 13 weeks ]
  8. Impression cytology [ Time Frame: 13 weeks ]
  9. Staining of the cornea with fluorescein [ Time Frame: 13 weeks ]
  10. Schirmer I test [ Time Frame: 13 weeks ]
  11. Subjective symptoms of dry eye syndrome [ Time Frame: 13 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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 ClinicalTrials.gov identifier (NCT number): NCT01579539


Locations
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Austria
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Gerhard Garhoefer, MD Department of Clinical Pharmacology, Medical University of Vienna
More Information
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Responsible Party: Gerhard Garhofer, Ass. Prof. PD. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01579539    
Other Study ID Numbers: OPHT-120312
First Posted: April 18, 2012    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Keywords provided by Gerhard Garhofer, Medical University of Vienna:
Methylprednisolone
Dry Eye Syndrome
Tear Film
Thyroid-associated ophthalmopathy
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases
Graves Ophthalmopathy
Thyroid Diseases
Endocrine System Diseases
Lacrimal Apparatus Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Eye Diseases, Hereditary
Graves Disease
Exophthalmos
 Orbital Diseases
Genetic Diseases, Inborn
Goiter
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Esomeprazole
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents