Clinical trial NCT01579539: The Effect of Intravenous Glucocorticoids on the Tearfilm in Eyes With Thyroid-associated Ophthalmopathy
Official title: The Effect of Intravenous Glucocorticoids on the Tearfilm in Eyes With Thyroid-associated Ophthalmopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Thyroid-associated Ophthalmopathy
Dry Eye Syndrome
Keywords: Methylprednisolone
Dry Eye Syndrome
Tear Film
Thyroid-associated ophthalmopathy
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2012-04-18
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Tear film thickness as measured with OCT
timeFrame: 13 weeks
Secondary outcomes:
measure: Break up time (BUT)
timeFrame: 13 weeks
measure: Visual acuity
timeFrame: 13 weeks
measure: Tear film osmolarity
timeFrame: 13 weeks
measure: Degree of exophthalmia
timeFrame: 13 weeks
measure: Palpebral fissure width
timeFrame: 13 weeks
measure: OSI (Objective Scattering Index)
timeFrame: 13 weeks
measure: Tear cytokines/chemokines
timeFrame: 13 weeks
measure: Impression cytology
timeFrame: 13 weeks
measure: Staining of the cornea with fluorescein
timeFrame: 13 weeks
measure: Schirmer I test
timeFrame: 13 weeks
measure: Subjective symptoms of dry eye syndrome
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
affiliation: Department of Clinical Pharmacology, Medical University of Vienna
name: Gerhard Garhoefer, MD
role: PRINCIPAL_INVESTIGATOR
References: