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

Study Overview
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Brief Summary
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To investigate the safety and efficacy of DE-101 to improve the signs and symptoms in dry-eye disease.

Official Title
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A Phase II Prospective, Randomized, Double-Masked, Parallel-Group, Multi-centered Study Assessing the Safety and Efficacy of Two Concentrations of DE-101 Ophthalmic Suspension Compared to Placebo for the Treatment of Dry Eye Disease

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Drug: DE-101 Ophthalmic Suspension
* Drug: DE-101 Ophthalmic Suspension
* Drug: DE-101 Ophthalmic Suspension Vehicle


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DE-101 Ophthalmic Suspension High Dose<br> | Drug: DE-101 Ophthalmic Suspension<br>* Ophthalmic suspension; QID<br>|
| Experimental: DE-101 Ophthalmic Suspension Low Dose<br> | Drug: DE-101 Ophthalmic Suspension<br>* Ophthalmic suspension; QID<br>|
| Placebo Comparator: DE-101 Ophthalmic Suspension Vehicle<br> | Drug: DE-101 Ophthalmic Suspension Vehicle<br>* Ophthalmic suspension vehicle; QID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear volume increase from baseline |  | baseline and 6 months |