Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Santen Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Individuals considered for entry into the study will be of either sex and any race who have:
a confirmed diagnosis of dry eye,
are willing to use no ocular treatments during the study other than study medication,
have a corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score of +0.7 logarithm of the minimum angle of resolution (logMAR) or better in each eye,
will not use contact lenses during the study,
Females of child-bearing potential must have a negative urine pregnancy test and be willing to use an acceptable method of contraception to be eligible for, and continue participation in, the study,
18 years of age or older,
able to understand and provide written informed consent
You may not be if
Fluorescein corneal staining or conjunctival staining that is too severe
Conditions requiring the use of ophthalmic prescription or over the counter medications during the study (except for study medications)
Any type of current punctal occlusion including punctal plugs, intracanalicular punctal plugs or cauterized puncta
Any type of ocular surgery within 90 days prior to Visit 1 (Day 1)
Known history of Steven-Johnson's syndrome, Riley-Day syndrome, and/or ocular pemphigoid
Ocular(including lid)disease/abnormality that may interfere with the study
Corneal transplant in either eye, at any time prior to enrollment in the study
Laser refractive surgery less than one year prior to Visit 1 (Day 1)
Conditions requiring the use of any systemic medication that is not ongoing at a stable dosage for at least 30 days prior to Visit 1 (Day 1)
Application of isotretinoin within 30 days prior to Visit 1 (Day 1)
Known allergy or sensitivity to any of the study medication components
Uncontrolled systemic conditions or other conditions which would confound the study evaluations or endanger the safety of the subject
A woman who is pregnant, nursing, or planning a pregnancy
Participation in another investigational drug or vaccine trial, or participation in such a trial within 30 days prior to Visit 1 (Day 1)
Clareo Health | A Study Assessing the Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients
