Phase
Condition
N/ATreatment
Dry Eye Disease
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
*Patients with the following: A diagnosis of dry eye disease Central or inferior corneal fluorescein staining defined by the Oxford Scale Reduced tear break up time (TBUT) ≤ 10 seconds.
Able to comprehend and sign a statement of informed consent.
Willing and able to complete all required postoperative visits.
Exclusion
Exclusion Criteria:
Ocular surgery (e.g., intraocular, oculoplastic, corneal, or refractive surgicalprocedure) performed within the last 3 months or at any time in the investigator'sclinical judgment if it would interfere with the outcome measures of this study.
Evidence of BAK or other chemical toxicity that, in the best judgment of theinvestigator, is causing reduced corneal sensitivity
Concomitant use of daily contact lenses that, in the best judgment of theinvestigator, is causing reduced corneal sensitivity
Clinically significant ocular trauma.
Active ocular Herpes simplex or Herpes Zoster infection
Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis,conjunctivitis) at the discretion of the investigator.
Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan, or fungalinfection or the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelidsincluding hordeolum/stye).
Active, systemic, or local disease condition that causes clinically significantocular surface irritation such that it could interfere with the study findings.
Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis.
Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis,staphylococcal blepharitis or seborrheic blepharitis)
Eyelid abnormalities that significantly affect the lid function (e.g., entropion,ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severeptosis).
Ocular surface abnormality that may compromise the corneal integrity (e.g., priorchemical burn, recurrent corneal erosion, map dot fingerprint dystrophy, or theeffect of any other ophthalmic medication that might in the opinion of theinvestigator compromise the ocular surface integrity).
Participation in this trial in the same patient's fellow eye
Patients who are under age 18, pregnant or breastfeeding, or who may become pregnantduring participation in the study.
Study Design
Study Description
Connect with a study center
Harvard Eye Associates
Laguna Beach, California 92653
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.