Phase
Condition
Eye Disorders/infections
Sjogren's Syndrome
Eyelid Inflammation
Treatment
Cenegermin Ophthalmic Solution [Oxervate]
Clinical Study ID
Ages 18-85 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:1. Provision of signed and dated informed consent form and HIPPA authorization.
Stated willingness to comply with all study procedures and availability for theduration of the study 3. Male or female, aged 18 to 85. 4. Subjects with moderate tosevere ocular pain defined as SANDE questionnaire score of >25 mm at time ofscreening not due to causes other than dry eye associated with NK in the opinion ofthe investigator.
Have used and/or desired to use an artificial tear substitute for dry eye symptomsin the past 3 months.
Have normal lid anatomy. 7. For females of reproductive potential:use of highlyeffective contraception for at least 1 month prior to screening and agreement to usesuch a method during study participation.
For males of reproductive potential:use of condoms or other methods to ensureeffective contraception with partner 9. Are postmenopausal (no menstrual cycle forat least one year prior to Visit 1) or have undergone bilateral tubal ligation,hysterectomy, hysterectomy with uni- or bilateral oophorectomy, or bilateraloophorectomy.
Patients with stage 1 NK characterized by epithelial irregularity most commonly inthe form of punctate keratopathy without epithelial defect or Stage 2 (persistentepithelial defect, PED).
PED or corneal ulceration of at least 2 weeks duration refractory to one or moreconventional non-surgical treatments for neurotrophic keratitis (e.g.,preservative-free artificial tears, gels or ointments; discontinuation of preservedtopical drops and medications that can decrease corneal sensitivity; therapeuticcontact lenses).
Evidence of decreased corneal sensitivity (≤ 4 cm using the Cochet-Bonnetaesthesiometer) within the area of the PED or corneal ulcer and outside of the areaof the defect in at least one corneal quadrant.
BCDVA of 20/200 or better by Snellen or >/=0.1 decimal units.
Exclusion
- Exclusion Criteria:
Have a known hypersensitivity or contraindication to the investigational product ortheir components.
Severe systemic allergy.
Topical glaucoma medications or oral medications that are not being taken at astable dose for the past 90 days.
Topical dry eye medications within the last month except unpreserved artificialtears which will be allowed throughout the study as needed.
Active viral, fungal or bacterial infection or active intraocular inflammation.
Subjects must be unwilling to abstain from eyelash growth medications for theduration of the trial.
Subjects must not have had penetrating intraocular surgery, refractive surgery orcorneal transplantation, eyelid surgery within 12 weeks prior to Visit 1.
Febrile illness within one week of screening visit.
Treatment with another investigational drug or other investigational interventionwithinone month of screening visit.
Have serious or severe disease or uncontrolled medical condition that in thejudgment of the investigator could confound study assessments or limit compliance.
Subjects that are currently pregnant or intend to become pregnant during the courseof the study, are breastfeeding, or who are unwilling to use highly effective birthcontrol measures such as hormonal contraceptives, and/or mechanical barrier methodsduring the course of the trial.
Use of contact lenses during trial.
Amniotic membranes within two weeks prior to screening.
Punctal plugs will be allowed as long as they have remained stable for at least 90days.
No neurostimulation including varencicline, acupuncture or TrueTear or like deviceswithin one month of screening.
Study Design
Connect with a study center
Toyos Clinic
Nashville, Tennessee 37215
United StatesSite Not Available
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