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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03216096
• Date of registration: 10/07/2017
• Prospective Registration: Yes
• Primary sponsor: Santen Pharmaceutical Co., Ltd.
• Public title: Assessing Safety and Efficacy of DE-089 Ophthalmic Solution in Patients With Dry Eye Disease
• Scientific title: A Prospective, Open Label, One-arm, 4-weeks Study Assessing Safety and Efficacy of DE-089 Ophthalmic Solution in Patients With Dry Eye Disease -Phase 1 Study in Dry Eye Patients
• Date of first enrolment: September 8, 2017
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03216096
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Taiwan

Key inclusion & exclusion criteria

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



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Dry Eye Disease

Intervention(s)

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

Primary Outcome(s)

Corneal fluorescein staining score [Time Frame: Week 4]

Secondary ID(s)

00891601

Source(s) of Monetary Support

Please refer to primary and secondary sponsors