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NCT Number: NCT01579539

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

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.

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Key information

Conditions

Thyroid-Associated Ophthalmopathy Autoimmune Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dry Eye Syndrome Dry Eye Syndromes Endocrine System Diseases Exophthalmos Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Goiter Graves Disease Graves Ophthalmopathy Hyperthyroidism Immune System Diseases Lacrimal Apparatus Diseases Orbital Diseases Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methylprednisolone

Drug

500mg i.v. infusion once a week for 6 weeks followed by 250mg i.v. infusion once a week for 6 weeks

Esomeprazole

Drug

40mg i.v. infusion once a week for 12 weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Apr 18, 2012
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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