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NCT01579539
The Effect of Intravenous Glucocorticoids on the Tearfilm in Eyes With Thyroid-associated Ophthalmopathy
Phase 3 trial testing Methylprednisolone in Thyroid-associated Ophthalmopathy in 18 participants. Completed in 18 May 2017.
18 May 2017
Quick facts
| Lead sponsor | Medical University of Vienna |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 27 June 2013 |
| Primary completion | 18 May 2017 |
| Estimated completion | 18 May 2017 |
| Sites | 1 location across Austria |
Drugs / interventions tested
- Methylprednisolone (methylprednisolone) — full drug profile →
- Esomeprazole (esomeprazole) — full drug profile →
Conditions studied
- Thyroid-associated Ophthalmopathy — all drugs for Thyroid-associated Ophthalmopathy →
- Dry Eye Syndrome — all drugs for Dry Eye Syndrome →
Sponsor
Medical University of Vienna
Who can join
18 and older, any sex, with Thyroid-associated Ophthalmopathy or Dry Eye Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01579539
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01579539 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medical University of Vienna
- Last refreshed: 20 February 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01579539.
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