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

Santen

Status and phase: Completed; Phase 2

Conditions: Dry Eye

Treatments: Drug: DE-110 ophthalmic suspension high dose; Other: Placebo; Drug: DE-110 ophthalmic suspension low dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01239069

30-002

Details and patient eligibility

About

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

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 3 patient groups, including a placebo group

DE-110 ophthalmic suspension high dose

Experimental group

Treatment:

Drug: DE-110 ophthalmic suspension high dose

DE-110 ophthalmic suspension low dose

Experimental group

Treatment:

Drug: DE-110 ophthalmic suspension low dose

Placebo

Placebo Comparator group

Treatment:

Other: Placebo