Phase
Condition
Dry Eye Disease
Sjogren's Syndrome
Dry Eyes
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Willing and able to read, sign, and date the informed consent and HIPAA documents
- Willing and able to comply with all study procedures
- Be at least 18 years of age
- Patient-reported history of dry eye in both eyes
- Demonstrate a positive response when exposed to the Controlled Adverse Environmentmodel
- A negative urine pregnancy test if female of childbearing potential and must useadequate birth control throughout the study period
Exclusion
Exclusion Criteria:
- Any ocular condition that, in the opinion of the Investigator, could affect studyparameters including, but not limited to, active ocular infection, ocularinflammation, glaucoma, and/or diabetic retinopathy
- Unwilling to avoid wearing contact lenses for 7 days prior to and for duration of thestudy period
- Any blood donation or significant loss of blood within 56 days of Visit 1
- Any history of immunodeficiency disorder, positive HIV, hepatitis B, C, or evidence ofacute active hepatitis A (anti-HAV IgM), or organ or bone marrow transplant.
- Use of any topical ophthalmic preparations (including artificial tear substitutes) 72hrs prior to Visit 1 and during the study
- Any significant chronic illness that could interfere with study parameters
- History of laser-assisted in situ keratomileusis (LASIK) or similar type of cornealrefractive surgery within 12 months prior to Visit 1, and/or any other ocular surgicalprocedure within 12 months prior to Visit 1; or any scheduled ocular surgicalprocedure during the study period.
- Known history of alcohol and/or drug abuse
- Subjects with Dry eye secondary to scarring or destruction of conjunctival gobletcells (as with Vitamin A deficiency)
Study Design
Connect with a study center
OPUS-1 Investigational Site
Phoenix, Arizona 85032
United StatesSite Not Available
OPUS-1 Investigational Site
Waterbury, Connecticut 06708
United StatesSite Not Available
OPUS-1 Investigational Site
Louisville, Kentucky 40405
United StatesSite Not Available
OPUS-1 Investigational Site
Augusta, Maine 04330
United StatesSite Not Available
OPUS-1 Investigational Site
Lewiston, Maine 04243
United StatesSite Not Available
OPUS-1 Investigational Site
Andover, Massachusetts 01840
United StatesSite Not Available
OPUS-1 Investigational Site
Lancaster, Massachusetts 01523
United StatesSite Not Available
OPUS-1 Investigational Site
Quincy, Massachusetts 02169
United StatesSite Not Available
OPUS-1 Investigational Site
Wakefield, Massachusetts 01880
United StatesSite Not Available
OPUS-1 Investigational Site
Winchester, Massachusetts 01890
United StatesSite Not Available
OPUS-1 Investigational Site
Las Vegas, Nevada 89131
United StatesSite Not Available
OPUS-1 Investigational Site
Derry, New Hampshire 03038
United StatesSite Not Available
OPUS-1 Investigational Site
Manchester, New Hampshire 03101
United StatesSite Not Available
OPUS-1 Investigational Site
Memphis, Tennessee 38119
United StatesSite Not Available
OPUS-1 Investigational Site
Norfolk, Virginia 23502
United StatesSite Not Available
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