A Study Assessing the Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients
Status: | Completed |
---|---|
Conditions: | Ocular, Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/14/2017 |
Start Date: | October 2011 |
End Date: | November 2012 |
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
To investigate the safety and efficacy of DE-101 to improve the signs and symptoms in dry-eye
disease.
disease.
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)
We found this trial at
13
sites
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