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NCT01239069 Clinical Trial

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

Dry Eye Clinical Trial

Official title:
A Phase II, Prospective, Randomized, Observer-masked, Parallel-group, Multi-center Study Assessing the Safety and Efficacy of Two Concentrations Compared to Placebo for the Treatment of Dry Eye Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01239069
Other study ID # 30-002
Secondary ID
Status Completed
Phase Phase 2
First received November 9, 2010
Last updated May 19, 2014
Start date November 2010
Est. completion date October 2011

Study information
Verified date May 2014
Source Santen Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 140
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• DE-110 ophthalmic suspension high dose
ophthalmic suspension; high dose; QID
• DE-110 ophthalmic suspension low dose
ophthalmic suspension; low dose; QID
Other:
• Placebo
DE-110 ophthalmic suspension vehicle;QID

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Santen Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy of DE-110 12 weeks
Secondary Individual Response Rate 12 weeks
Secondary Individual Efficacy 12 weeks
Secondary Individual Symptoms 12 weeks
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