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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 : Recruiting
First Posted : April 18, 2012
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna

April 13, 2012
April 18, 2012
June 8, 2018
June 2013
December 2018   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01579539 on ClinicalTrials.gov Archive Site
  • Break up time (BUT) [ Time Frame: 13 weeks ]
  • Visual acuity [ Time Frame: 13 weeks ]
  • Tear film osmolarity [ Time Frame: 13 weeks ]
  • Degree of exophthalmia [ Time Frame: 13 weeks ]
    Hertel exophthalmometry
  • Palpebral fissure width [ Time Frame: 13 weeks ]
  • OSI (Objective Scattering Index) [ Time Frame: 13 weeks ]
  • Tear cytokines/chemokines [ Time Frame: 13 weeks ]
  • Impression cytology [ Time Frame: 13 weeks ]
  • Staining of the cornea with fluorescein [ Time Frame: 13 weeks ]
  • Schirmer I test [ Time Frame: 13 weeks ]
  • Subjective symptoms of dry eye syndrome [ Time Frame: 13 weeks ]
Same as current
Not Provided
Not Provided
 
The Effect of Intravenous Glucocorticoids on the Tearfilm in Eyes With Thyroid-associated Ophthalmopathy
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.

Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Thyroid-associated Ophthalmopathy
  • Dry Eye Syndrome
  • 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
Experimental: Patients
Patients with moderate to severe thyroid-associated ophthalmopathy
Interventions:
  • Drug: Methylprednisolone
  • Drug: Esomeprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
Same as current
December 2018
December 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Gerhard Garhoefer, MD +43140400 ext 2981 gerhard.garhoefer@meduniwien.ac.at
Austria
 
 
NCT01579539
OPHT-120312
Yes
Not Provided
Not Provided
Gerhard Garhofer, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Gerhard Garhoefer, MD Department of Clinical Pharmacology, Medical University of Vienna
Medical University of Vienna
June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP