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

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Stanford University

Status and phase

Withdrawn
Phase 4

Conditions

Glaucoma
Ocular Hypertension
Thyroid Eye Disease

Treatments

Drug: Timolol
Drug: Prostaglandin Analog

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 2 patient groups

Prostaglandin Analog vs Timolol
Experimental group
Description:
In this group, with thyroid eye disease and increased intraocular pressure in both eyes, prostaglandin analog eyedrop (bimatoprost 0.01%, travoprost z 0.004%, tafluprost 0.0015% or latanoprost 0.005%) will be administered once a day, topically, into one - randomised eye. Timolol 0.5% eye drop will be administered topically in second, control eye, two times a day.
Treatment:
Drug: Prostaglandin Analog
Drug: Timolol
Prostaglandin Analog
Experimental group
Description:
In this group, with thyroid eye disease and increased intraocular pressure in only one eye Prostaglandin Analog eyedrop (bimatoprost 0.01%, travoprost z 0.004%, tafluprost 0.0015% or latanoprost 0.005%) will be administered once a day, topically, into one, affected eye.
Treatment:
Drug: Prostaglandin Analog

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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