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This purpose of this study is to assess the safety and effectiveness of Restasis (R) ophthalmic emulsion versus emulsion alone( Refresh Dry Eye therapy) both for the treatment of brittle nails and for the enhancement of normal nail growth and texture. The investigators think that daily application of Restasis (R) to nails and nail beds in patients with brittle nails will enhance nail growth and improve nail texture in both affected and unaffected nails.
This is a single center, investigator-blinded (investigator masked), head to head comparison of Restasis(R) and its vehicle, Refresh(R) Dry Eye Therapy in 24 patients. Three target fingernails will be identified in each subject. Two of the target nails will be the two nails that have the most severe signs of brittle nail syndrome. The third target nail will be a normal nail or, in the absence of a normal nail, the patient's second-healthiest appearing nail. The patients most normal-appearing nail will be untreated so that growth in the treated nails can be compared to growth in an untreated normal nail, this will be the fourth target nail. Study medication will be applied to target nails (the subjects may also apply to all nails if they wish, except one nail which will be untreated in order to determine the subject's baseline rate of fingernail growth) for 24 weeks. The target nails will be assessed at each visit, every four weeks. There will be a 12-week follow up period after treatment is completed.
This 36 week study will be conducted at one center. Adult male and female patients meeting the inclusion and exclusion criteria will be screened for eligibility. The principal investigator or his/her designee will obtain informed consent from all patients before any protocol specific procedures are performed.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Restasis (cyclosporine ophthalmic emulsion) 0.05%, Refresh(R) Dry Eye therapy
Columbia University Medical Center Department of Dermatology
Active, not recruiting
Published on BioPortfolio: 2014-08-27T03:18:59-0400
This study will evaluate the safety and efficacy of cyclosporine ophthalmic emulsion administered twice daily following LASIK surgery
Brittle nail syndrome (BNS) refers to nails that exhibit splitting, raggedness (fraying of the distal edge), and peeling (lamellar onychoschizia).(1) This is a common problem, affecting ap...
The objective of this retrospective chart review is to evaluate the patient characteristics, treatment variations and efficacy of a second trial of Cyclosporine Ophthalmic Emulsion 0.05% t...
This study will evaluate the safety and efficacy of Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) in patients with primary pterygium (abnormal growth on surface of eye).
To evaluate the efficacy of 0.05% cyclosporine ophthalmic emulsion (Restasis® , Allergan) versus an artificial tears alone in patients with meibomian gland dysfunction that have abnormal ...
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Deformities in nail structure or appearance, including hypertrophy, splitting, clubbing, furrowing, etc. Genetic diseases such as PACHYONYCHIA CONGENITA can result in malformed nails.
A sensory branch of the trigeminal (5th cranial) nerve. The ophthalmic nerve carries general afferents from the superficial division of the face including the eyeball, conjunctiva, upper eyelid, upper nose, nasal mucosa, and scalp.
Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.
A 17-KDa cytoplasmic PEPTIDYLPROLYL ISOMERASE involved in immunoregulation. It is a member of the cyclophilin family of proteins that binds to CYCLOSPORINE.
An emulsion of solid color which when spread over a surface leaves a thin decorative and or protective coating.
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...