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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: DE-101 Ophthalmic Suspension; Drug: DE-101 Ophthalmic Suspension Vehicle

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • New Port Beach, California, United States, 92663
  • Colorado
    • Parker, Colorado, United States, 80134
  • Florida
    • Largo, Florida, United States, 33773
  • Georgia
    • Morrow, Georgia, United States, 30260
    • Roswell, Georgia, United States, 30076
  • Maine
    • Bangor, Maine, United States, 04401
  • Missouri
    • Kansas City, Missouri, United States, 64111
    • Saint Louis, Missouri, United States, 63131
    • Washington, Missouri, United States, 63090
  • North Carolina
    • High Point, North Carolina, United States, 27262
  • Ohio
    • Cleveland, Ohio, United States, 44115
  • Utah
    • Salt Lake City, Utah, United States, 84107
  • Virginia
    • Norfolk, Virginia, United States, 23507

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Santen Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: November 7, 2011
• First Submitted That Met QC Criteria: November 8, 2011
• First Posted (Estimate): November 9, 2011

Study Record Updates

• Last Update Posted (Estimate): December 17, 2012
• Last Update Submitted That Met QC Criteria: December 14, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: 26-005