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

Phase 2

Completed

• Conditions: Dry Eye Disease
• Interventions: Drug: DE-101 Ophthalmic Suspension; Drug: DE-101 Ophthalmic Suspension Vehicle

• Registration Number: NCT01468168
• Lead Sponsor: Santen Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-11-07
• Study First Submitted QC: 2011-11-08
• Study First Posted: 2011-11-09
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-14
• Last Update Posted: 2012-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DE-101 Ophthalmic Suspension High Dose	DE-101 Ophthalmic Suspension	-
DE-101 Ophthalmic Suspension Low Dose	DE-101 Ophthalmic Suspension	-
DE-101 Ophthalmic Suspension Vehicle	DE-101 Ophthalmic Suspension Vehicle	-

Primary Outcome Measures

Name	Time	Method
Tear volume increase from baseline	baseline and 6 months