A Study Assessing the Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients

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)