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

Clalit Health Services

Status and phase: Completed; Phase 3

Conditions: Thyroid Associated Ophthalmopathies

Treatments: Drug: bimatoprost 0.03%

Study type: Interventional

Funder types: Other

Identifiers

NCT02155049

Thyroid eye disease (Registry Identifier)

TED-01

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Prostaglandin Analogues

Experimental group

Description:

The patients will receive a single daily drop of bimatoprost for six months.

Treatment:

Drug: bimatoprost 0.03%