Safety and Efficacy Study of DE-110 Ophthalmic Suspension for the Treatment of Dry Eye Disease

Phase 2

Completed

• Conditions: Dry Eye
• Interventions: Other: Placebo; Drug: DE-110 ophthalmic suspension low dose; Drug: DE-110 ophthalmic suspension high dose

• Registration Number: NCT01239069
• Lead Sponsor: Santen Inc.

Brief Summary

Investigate the Safety and Efficacy of Two Concentrations of DE-110 Compared to Placebo for the Treatment of Dry Eye Disease

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-09
• Study First Submitted QC: 2010-11-09
• Study First Posted: 2010-11-11
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-19
• Last Update Posted: 2014-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Confirmed diagnosis of dry eye
• Not wear contact lenses during study
• 18 years or older
• Understand and provide written consent
• Negative pregnancy test and use acceptable method of contraception

Exclusion Criteria

• Use of any topical ocular medication
• Any type of ocular surgery
• Diagnosis of on-going ocular infection and/or allergic conjunctivitis
• Uncontrolled systemic conditions/lid abnormalities
• Corneal transplants
• Females who are pregnant, nursing or planning a pregnancy
• Participation in another drug trial concurrently or within 30 days prior to study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
DE-110 ophthalmic suspension low dose	DE-110 ophthalmic suspension low dose	-
DE-110 ophthalmic suspension high dose	DE-110 ophthalmic suspension high dose	-

Primary Outcome Measures

Name	Time	Method
Efficacy of DE-110	12 weeks

Secondary Outcome Measures

Name	Time	Method
Individual Response Rate	12 weeks
Individual Efficacy	12 weeks
Individual Symptoms	12 weeks