Clinical trial NCT01468168: A Study Assessing the Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Disease
Lead sponsor: Santen Inc.
Sponsor class: INDUSTRY
First posted: 2011-11-09
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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)

Primary outcomes:
measure: Tear volume increase from baseline
timeFrame: baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Port Beach
country: United States
state: California
city: Parker
country: United States
state: Colorado
city: Largo
country: United States
state: Florida
city: Morrow
country: United States
state: Georgia
city: Roswell
country: United States
state: Georgia
city: Bangor
country: United States
state: Maine
city: Kansas City
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Washington
country: United States
state: Missouri
city: High Point
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Salt Lake City
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
Study officials:
References: