Assessing Safety and Efficacy of DE-089 Ophthalmic Solution in Patients With Dry Eye Disease

Santen

Status and phase: Completed; Phase 1

Conditions: Dry Eye Disease

Treatments: Drug: Placebo ophthalmic solution and 3% DE-089 ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT03216096

00891601

Details and patient eligibility

About

The objective of this study is to assess safety and efficacy of DE-089 ophthalmic solution in patients with dry eye disease in Taiwan.

Enrollment: 20 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 6-month dry eye history

Exclusion criteria

• Diagnosed with Stevens-Johnson Syndrome or ocular pemphigoid
• Diagnosed with keratoconjunctival chemical burns or thermal burn
• Eye disease other than dry eye disease which needs treatment
• Allergic conjunctivitis that may possibly be aggravated during the clinical study and inappropriate for efficacy evaluation
• Those who need to wear contact lenses during the clinical study
• Those who are considered inappropriate for this study by the investigator or subinvestigators

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

3% DE-089 ophthalmic solution

Experimental group

Treatment:

Drug: Placebo ophthalmic solution and 3% DE-089 ophthalmic solution