Dry Eye Disease
Conditions
Brief summary
To investigate the safety and efficacy of DE-101 to improve the signs and symptoms in dry-eye disease.
Interventions
Ophthalmic suspension; QID
Ophthalmic suspension vehicle; QID
Sponsors
Santen Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Subjects with any of the following are not eligible to participate in the study: * 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tear volume increase from baseline | baseline and 6 months |
Countries
United States
Outcome results
None listed