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

Completed · Phase 2

Conditions studied: Dry Eye Disease

In brief

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

Key facts

Study ID

NCT01468168

Run by

Santen Inc.

People needed

183

Starts

2011-10-01

Expected to finish

2012-11-01

Last updated by the study team

2012-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Study site — New Port Beach, California, United States
• Study site — Parker, Colorado, United States
• Study site — Largo, Florida, United States
• Study site — Morrow, Georgia, United States
• Study site — Roswell, Georgia, United States
• Study site — Bangor, Maine, United States
• Study site — Kansas City, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Washington, Missouri, United States
• Study site — High Point, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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