The Effect of Intravenous Glucocorticoids on the Tearfilm in Eyes With Thyroid-associated Ophthalmopathy
Primary Purpose
Thyroid-associated Ophthalmopathy, Dry Eye Syndrome
Status
Completed
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
Methylprednisolone
Esomeprazole
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid-associated Ophthalmopathy focused on measuring Methylprednisolone, Dry Eye Syndrome, Tear Film, Thyroid-associated ophthalmopathy
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
Sites / Locations
- Department of Clinical Pharmacology, Medical University of Vienna
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients
Arm Description
Patients with moderate to severe thyroid-associated ophthalmopathy
Outcomes
Primary Outcome Measures
Tear film thickness as measured with OCT
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)
Visual acuity
Tear film osmolarity
Degree of exophthalmia
Hertel exophthalmometry
Palpebral fissure width
OSI (Objective Scattering Index)
Tear cytokines/chemokines
Impression cytology
Staining of the cornea with fluorescein
Schirmer I test
Subjective symptoms of dry eye syndrome
Full Information
NCT ID
NCT01579539
First Posted
April 13, 2012
Last Updated
February 19, 2020
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT01579539
Brief Title
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
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 27, 2013 (Actual)
Primary Completion Date
May 18, 2017 (Actual)
Study Completion Date
May 18, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid-associated Ophthalmopathy, Dry Eye Syndrome
Keywords
Methylprednisolone, Dry Eye Syndrome, Tear Film, Thyroid-associated ophthalmopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Experimental
Arm Description
Patients with moderate to severe thyroid-associated ophthalmopathy
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
500mg i.v. infusion once a week for 6 weeks followed by 250mg i.v. infusion once a week for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Intervention Description
40mg i.v. infusion once a week for 12 weeks
Primary Outcome Measure Information:
Title
Tear film thickness as measured with OCT
Description
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
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
Break up time (BUT)
Time Frame
13 weeks
Title
Visual acuity
Time Frame
13 weeks
Title
Tear film osmolarity
Time Frame
13 weeks
Title
Degree of exophthalmia
Description
Hertel exophthalmometry
Time Frame
13 weeks
Title
Palpebral fissure width
Time Frame
13 weeks
Title
OSI (Objective Scattering Index)
Time Frame
13 weeks
Title
Tear cytokines/chemokines
Time Frame
13 weeks
Title
Impression cytology
Time Frame
13 weeks
Title
Staining of the cornea with fluorescein
Time Frame
13 weeks
Title
Schirmer I test
Time Frame
13 weeks
Title
Subjective symptoms of dry eye syndrome
Time Frame
13 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Garhoefer, MD
Organizational Affiliation
Department of Clinical Pharmacology, Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Pharmacology, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
The Effect of Intravenous Glucocorticoids on the Tearfilm in Eyes With Thyroid-associated Ophthalmopathy
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