The Secondary Beneficial Effects of Prostaglandin Analog Treatment in Thyroid Eye Disease Patients.

Glaucoma Clinical Trial

Official title:

The Secondary Beneficial Effects of Prostaglandin Analog Treatment in Thyroid Eye Disease Patients.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01927406
• Other study ID #: 26654
• Status: Withdrawn
• Phase: Phase 4
• Start date: June 2014
• Est. completion date: December 2016

Study information

• Verified date: May 2018
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the potential secondary beneficial effect of prostaglandin analogues (PA) treatment in thyroid eye disease (TED) patients. This study aims to determine if PA would change the course of the orbitopathy in TED patients by altering the progression of the common features of TED, including fatty hypertrophy, proptosis, eyelid retraction and optic nerve compression. The eyes with thyroid eye disease and elevated intraocular pressure will be randomised to the PA treatment and the other eye will serve as a control eye and will be treated with Timolol.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• mild or moderate to severe thyroid eye disease in one or both eyes

• age > 18 years

• informed consent

• intraocular pressure > 21 mmHg or glaucoma suspect or glaucoma diagnosed in one or both eyes

• not on current prostaglandin analog intraocular pressure lowering therapy

Exclusion Criteria:

• sight threatening thyroid eye disease

• children < 18 years old

• patients that are not compliant with treatment or follow-up

• patients already on prostaglandin analog treatment

• patients that undergo cosmetic periocular procedures during the study will be excluded from further follow up

• patients that cannot tolerate prostaglandin analog treatment.

• patients with bilateral thyroid eye disease and elevated intraocular pressures that cannot tolerate treatment with timolol or an alternative intraocular pressure lowering medication such as trusopt, combigan, cosopt.

Related Conditions & MeSH terms

• Eye Diseases
• Glaucoma
• Graves Ophthalmopathy
• Ocular Hypertension
• Thyroid Diseases
• Thyroid Eye Disease

Intervention

Drug:
• Prostaglandin Analog
The first choice drug from group of Prostaglandin Analogues will be bimatoprost, if patient will suffer from any side effect of this drug another drug from this group will be administer. If patient turned out to cannot tolerate the prostaglandin analog therapy then the exclusion criteria will be met.
• Timolol
Timolol topical eye drop will be administered in Prostaglandin Analog vs Timolol arm only, in patients with elevated intraocular pressure in both eyes.

Locations

Country	Name	City	State
United States	Stanford Hospital and Clinics	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in appearance of facial periorbital region at 6 months.		Baseline and 6 months
Secondary	Change from baseline in Hertel exophthalmometry at 3, 6, 9 and 12 months.		Baseline and 3, 6, 9 and 12 months
Secondary	Change from baseline in intraocular pressure at 3, 6, 9 and 12 months.		Baseline and 3, 6, 9 and 12 months
Secondary	Change from baseline in appearance of facial periorbital region at 3, 6, 9 and 12 months.		Baseline and 3, 6, 9 and 12 months