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

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT01579539

Collaborator

(none)

Enrollment

Location

Arm

46.7

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Jun 27, 2013

Actual Primary Completion Date :

May 18, 2017

Actual Study Completion Date :

May 18, 2017

Arms and Interventions

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

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

Primary Outcome Measures

Tear film thickness as measured with OCT [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

Break up time (BUT) [13 weeks]
Visual acuity [13 weeks]
Tear film osmolarity [13 weeks]
Degree of exophthalmia [13 weeks]
Hertel exophthalmometry
Palpebral fissure width [13 weeks]
OSI (Objective Scattering Index) [13 weeks]
Tear cytokines/chemokines [13 weeks]
Impression cytology [13 weeks]
Staining of the cornea with fluorescein [13 weeks]
Schirmer I test [13 weeks]
Subjective symptoms of dry eye syndrome [13 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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