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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01239069
• Date of registration: 09/11/2010
• Primary sponsor: Santen Inc.
• Public title: Safety and Efficacy Study of DE-110 Ophthalmic Suspension for the Treatment of Dry Eye Disease
• Scientific 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
• Date of first enrolment: November 2010
• Target sample size: 160
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01239069
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Countries of recruitment

United States

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Dry Eye

Intervention(s)

Drug: DE-110 ophthalmic suspension high dose

Drug: DE-110 ophthalmic suspension low dose

Other: Placebo

Primary Outcome(s)

Efficacy of DE-110 [Time Frame: 12 weeks]

Secondary Outcome(s)

Individual Efficacy [Time Frame: 12 weeks]

Individual Response Rate [Time Frame: 12 weeks]

Individual Symptoms [Time Frame: 12 weeks]

Secondary ID(s)

30-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors