The Secondary Beneficial Effects of Prostaglandin Analog Treatment in Thyroid Eye Disease Patients.
This study is not yet open for participant recruitment.
(see Contacts and Locations)
Verified August 2013 by Stanford University
Sponsor:
Stanford University
Information provided by (Responsible Party):
Andrea L Kossler, Stanford University
ClinicalTrials.gov Identifier:
NCT01927406
First received: August 16, 2013
Last updated: August 19, 2013
Last verified: August 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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:
Genetics Home Reference related topics:
early-onset glaucoma
Graves disease
Lenz microphthalmia syndrome
oculofaciocardiodental syndrome
Drug Information available for:
Thyroid
Timolol
Timolol maleate
Latanoprost
Bimatoprost
Travoprost
Tafluprost
U.S. FDA Resources
Further study details as provided by Stanford University:
Primary Outcome Measures:
- Change from baseline in appearance of facial periorbital region at 12 months. [ Time Frame: 0 and 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline in Hertel exophthalmometry at 12 and 24 months. [ Time Frame: 0 and 24 months ] [ Designated as safety issue: No ]
- Change from baseline in intraocular pressure at 12 and 24 months. [ Time Frame: 0 and 24 months ] [ Designated as safety issue: No ]
- Change from baseline in appearance of facial periorbital region at 24 months. [ Time Frame: 0 and 24 months ] [ Designated as safety issue: No ]
| 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.
|
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%
|
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01927406
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| Responsible Party: | Andrea L Kossler, M.D., Stanford University |
| ClinicalTrials.gov Identifier: | NCT01927406 History of Changes |
| Other Study ID Numbers: | 26654 |
| Study First Received: | August 16, 2013 |
| Last Updated: | August 19, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Stanford University:
|
Thyroid Eye Disease Graves' Disease Prostaglandin Analogues |
Additional relevant MeSH terms:
|
Graves Disease Eye Diseases Graves Ophthalmopathy Ocular Hypertension Autoimmune Diseases Endocrine System Diseases Exophthalmos Eye Diseases, Hereditary Goiter Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Diseases |
Bimatoprost Timolol Adrenergic Agents Adrenergic Antagonists Adrenergic beta-Antagonists Anti-Arrhythmia Agents Antihypertensive Agents Cardiovascular Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015