Status:
COMPLETED
A Study Assessing the Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients
Lead Sponsor:
Santen Inc.
Conditions:
Dry Eye Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To investigate the safety and efficacy of DE-101 to improve the signs and symptoms in dry-eye disease.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT01468168
Start Date
October 1 2011
End Date
November 1 2012
Last Update
December 17 2012
Active Locations (13)
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1
New Port Beach, California, United States, 92663
2
Parker, Colorado, United States, 80134
3
Largo, Florida, United States, 33773
4
Morrow, Georgia, United States, 30260