Treatment of Soft Tissue Expansion in Inactive Thyroid Eye Disease Patients Using Drops of Prostaglandin Analogues

Thyroid Associated Ophthalmopathies Clinical Trial

Official title:

Phase 3 Study of Treatment of Soft Tissue Expansion and Exophthalmos in Inactive Thyroid Eye Disease Patients Using Drops of Prostaglandin Analogues.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02155049
• Other study ID #: TED-01
• Secondary ID: Thyroid eye dise
• Status: Completed
• Phase: Phase 3
• First received: May 21, 2014
• Last updated: February 15, 2018
• Start date: November 2014
• Est. completion date: May 2017

Study information

• Verified date: February 2018
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prostaglandin analogues eye drops are common and effective treatment for decreasing Intra-Ocular Pressure (IOP) in Glaucoma patients. A number of recently published case reports have documented periorbital fat atrophy following treatment by prostaglandin analogues. In this study the investigators want to use this side-effect of prostaglandin analogues for the treatment of orbital and periocular fat proliferation in inactive Thyroid eye disease (TED) patients, as a conservative substitute for surgical intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Inactive TED (Clinical Activity Score below 3)

• Significant exophthalmos or orbital fat expansion.

Exclusion Criteria:

• Previous prostaglandin analogues treatment due to glaucoma

• Known prostaglandin analogues sensitivity.

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Thyroid Associated Ophthalmopathies
• Thyroid Diseases

Intervention

Drug:
• bimatoprost 0.03%
The patients will receive a single daily drop of bimatoprost for six months.

Locations

Country	Name	City	State
Israel	Ophthalmology clinics, Rabin Medical Center	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bimatoprost effect reversibility after treatment cessation.	To measure the reversibility of bimatoprost treatment on the amount of soft tissue and exophthalmos at the end of the treatment course and 3 months post cessation. We shall perform the same measurements as described in the Primary Outcome section.	3 months
Primary	Bimatoprost effect on soft tissue amount and exophthalmos in inactive TED patients.	To document the effect of bimatoprost treatment on the amount of soft tissue and exophthalmos in inactive TED patients. The following measurements will be performed pre, post and during treatment: orbital ultrasound (measuring the eyebrow fat, retro-orbicularis oculi fat and retrobulbar fat), Hertel exophthalmometry and Marginal Reflex Distance (MRD). The external appearance would be also documented by face picture.	6 months
Secondary	Number of participants with adverse events.	Determine the safety of bimatoprost treatment by estimating the probabilities of adverse outcomes. To estimate these probabilities we shall count the number of participants suffering from known side-effects of prostaglandin analogues such as increased eyelash growth and darkening of the periocular skin and iris; as well as any other side-effects observed during treatment.	9 months