Intervention: Soothe
Trial phase: Phase 2
SMILES: O=C1CCCN1C(P)CP
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
Eligibility criteria:
Inclusion Criteria:

must have IRB approved written informed consent prior to participating in any study related procedures
Must be a male or female patient 18 to 75 years of age
must have a diagnosis of brittle or meet the criteria for a diagnosis of brittle nails at the screening visit based on at least two of the following signs and symptoms of brittle nails in each of the selected nail plates or severe signs (one or more) on each target nail
trachyonychia (surface roughness)
lamellar onychoschizia (horizontal layering/peeling
longitudinal cracking or splitting of the distal edge (raggedness)
must have two fingernails with brittle nail signs and symptoms identified at baseline
must have two normal or near-normal nails on the same hand
female patients of childbearing potential (not surgically sterile or at least 2 years postmenopausal) must have a negative pregnancy at baseline/day 1 and may not be lactating
sexually active female subjects who are not surgically sterile or 2 years post menopausal must agree to use contraception/birth control measure while on study (e.g., oral contraceptive, diaphragms with spermicide, condoms with spermicide, intrauterine devices, Norplant System, Depo-Provera, tubal ligation). Monthly urine pregnancy tests will be administered to women of childbearing potential
must agree to self administer topical study medication, and must agree to complete all study procedures
must be judged to be in good health by medical history and physical examination
must be able to adhere to the study visit schedule and other protocol requirements, including avoiding the use of nail polish, adhesive nails, and manicures for the duration of the study

Exclusion Criteria:

have a history of surgery of the affected fingernails
are chronic nail biters
are pregnant, nursing, or planning pregnancy prior to study enrollment
have a disturbance of the shape of the affected fingernails (e.g., due to malformation of the underlying bone) that would interfere with the investigator's ability to evaluate photographs or nail changes
have onycholysis (lifting of the nail plate off the nail bed) of the affected fingernails
have signs of a fungal or bacterial infection of the affected fingernails
have a history of psoriasis or lichen planus involving any nail, or active contact dermatitis involving the affected fingernails
have used any topical cosmetics or medicated products on the affected nails within 2 weeks of baseline visit
have received oral antifungal treatment within 3 months of baseline visit
have a known or suspected history of a genetic condition affecting the nails (e.g., Darier's disease, nail-patella syndrome, tuberous sclerosis)
have used any investigational drug within the previous 1 month or 5 half-lives of the investigational agent, whichever is longer, or 3 months for any biologic of unknown half-life
are known or suspected to have had a substance abuse (drug or alcohol) problem within the previous 3 years
is unlikely to comply with the study protocol and prescribed treatment or is unsuitable for any other reason in the opinion of the investigator
chronic liver, heart, kidney, or (untreated) thyroid disease
have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease
currently have any known malignancy or have a history of malignancy other than non-melanoma skin cancer
have signs of bacterial, fungal or viral skin lesions that may interfere with evaluation of the target nails
known sensitivity to any active or inactive ingredient in Restasis(R) or Refresh(R) Dry Eye Therapy