The Secondary Beneficial Effects of Prostaglandin Analog Treatment in Thyroid Eye Disease Patients.
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by Andrea L Kossler, Stanford University.
Recruitment status was: Not yet recruiting
Recruitment status was: Not yet recruiting
Sponsor:
Stanford University
ClinicalTrials.gov Identifier:
NCT01927406
First Posted: August 22, 2013
Last Update Posted: August 22, 2013
Information provided by (Responsible Party):
Andrea L Kossler, Stanford University
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Thyroid Eye Disease Ocular Hypertension Glaucoma | Drug: Prostaglandin Analog Drug: Timolol | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | The Secondary Beneficial Effects of Prostaglandin Analog Treatment in Thyroid Eye Disease Patients. |
Resource links provided by NLM:
Further study details as provided by Andrea L Kossler, Stanford University:
Primary Outcome Measures:
- Change from baseline in appearance of facial periorbital region at 12 months. [ Time Frame: 0 and 12 months ]
Secondary Outcome Measures:
- Change from baseline in Hertel exophthalmometry at 12 and 24 months. [ Time Frame: 0 and 24 months ]
- Change from baseline in intraocular pressure at 12 and 24 months. [ Time Frame: 0 and 24 months ]
- Change from baseline in appearance of facial periorbital region at 24 months. [ Time Frame: 0 and 24 months ]
| Estimated Enrollment: | 30 |
| Study Start Date: | August 2013 |
| Estimated Study Completion Date: | August 2015 |
| Estimated Primary Completion Date: | August 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Prostaglandin Analog vs Timolol
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.
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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.
Other Names:
Drug: Timolol
Timolol topical eye drop will be administered in Prostaglandin Analog vs Timolol arm only, in patients with elevated intraocular pressure in both eyes.
Other Name: Timolol maleate 0.5%
|
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Experimental: Prostaglandin Analog
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.
|
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.
Other Names:
|
Eligibility
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01927406
Contacts
| Contact: Barbara Bartlett | 650-724-9259 | bbartlet@stanford.edu |
Locations
| United States, California | |
| Stanford Hospital and Clinics | Not yet recruiting |
| Stanford, California, United States, 94304 | |
| Contact: Barbara Bartlett 650-724-9259 bbartlet@stanford.edu | |
Sponsors and Collaborators
Stanford University
Investigators
| Principal Investigator: | Andrea L. Kossler, M.D. | Stanford University |
More Information
| Responsible Party: | Andrea L Kossler, M.D., Stanford University |
| ClinicalTrials.gov Identifier: | NCT01927406 History of Changes |
| Other Study ID Numbers: |
26654 |
| First Submitted: | August 16, 2013 |
| First Posted: | August 22, 2013 |
| Last Update Posted: | August 22, 2013 |
| Last Verified: | August 2013 |
Keywords provided by Andrea L Kossler, Stanford University:
|
Thyroid Eye Disease Graves' Disease Prostaglandin Analogues |
Additional relevant MeSH terms:
|
Thyroid Diseases Ocular Hypertension Eye Diseases Graves Ophthalmopathy Endocrine System Diseases Eye Diseases, Hereditary Graves Disease Exophthalmos Orbital Diseases Goiter Hyperthyroidism Autoimmune Diseases Immune System Diseases |
Timolol Latanoprost Bimatoprost Travoprost Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Arrhythmia Agents Antihypertensive Agents |