NCT01162954CompletedPhase 1
A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Local Tolerability After Administration of Eye Drop DA-6034 in Healthy Volunteers(Phase I)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Dong-A ST Co., Ltd.
- Locations
- 1
- Primary Endpoint
- Ocular symptomatology, ophthalmologic tests
Study Overview
Brief Summary
This is a double-blind, randomized, placebo-controlled, 4-period, cross-over clinical trial. The study is designed to evaluate the safety and local tolerability of DA-6034 upon single and repeated-dose topical application to the both eyes in healthy volunteers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •20-50 year-old healthy subjects
Exclusion Criteria
- •Presence or history of dry eye or other ocular or systemic diseases
- •Corrected visual acuity less than 20/40 in either eye at the screening
- •Any eye surgery or laser eye surgery within the past six months
- •Intraocular pressure greater than 22 mmHg in either eye at the screening
- •Break-up time less than 10 sec with OSDI score corresponding to mild to severe dry eye symptoms in either eye at the screening
- •Unanesthetized Schirmer scores <10 mm in either eye at the screening
Arms & Interventions
DA-6034
Experimental
Intervention: DA-6034 (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Ocular symptomatology, ophthalmologic tests
Time Frame: Single dose: up to 5 days, Multiple dose: up to 15 days
Secondary Outcomes
- Adverse events, vital signs, physical examinations, ECG findings, clinical laboratory tests, ocular symptomatology, ophthalmologic tests, Unanesthetized Schirmer tests(Single dose: up to 10 days, Multiple dose: up to 20 days)
Investigators
Study Sites (1)
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