Vision Institute | Colorado Springs, CO
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About
To demonstrate the safety and effectiveness of TearCare® procedures compared to Restasis® to treat the signs and symptoms of dry eye disease in adult patients.
Enrollment
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Volunteers
Inclusion criteria
Exclusion criteria
Use of any of the following medications:
Any of the following dry eye treatments:
History of eyelid, conjunctiva or corneal surgery (including refractive surgery) within the past year. In addition, subjects with any history of the following are excluded: chalazion surgery, surgery on the tarsal conjunctiva, radial keratotomy (RK), complicated blepharoplasty, lid reconstruction, or significant complications post-refractive surgery.
Contact lens use within the past 2 weeks.
History of Ocular Herpes Simplex or Ocular Herpes Zoster
Any active, clinically significant ocular or peri-ocular infection or inflammation
Recurrent clinically significant eye inflammation, other than dry eye, within 3 months prior to enrollment
Clinically significant anterior blepharitis. In addition, collarettes or flakes of more than one quarter of the eyelid are excluded.
Clinically significant eyelid abnormalities in either eye (e.g. entropion/ectropion, blepharospasm, aponeurotic ptosis, lagophthalmos, distichiasis, trichiasis).
Clinically significant dermatologic or cutaneous disease of the eyelid or periocular area.
Primary purpose
Allocation
Interventional model
Masking
350 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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