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Completed

NCT Number: NCT01162954

Phase I Study to Evaluate the Tolerability of Eye Drop DA-6034 in Healthy Volunteers

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.

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Key information

Conditions

Dry Eye Syndrome Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Research Institue, Seoul National University Hospital

Seoul, Chongno-Gu, Yon-Gon Dong 28, 110-744, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DA-6034

Drug

Placebo

Drug

Primary outcomes

  1. Ocular symptomatology, ophthalmologic tests

    Time frame: Single dose: up to 5 days, Multiple dose: up to 15 days

Secondary outcomes

  1. Adverse events, vital signs, physical examinations, ECG findings, clinical laboratory tests, ocular symptomatology, ophthalmologic tests, Unanesthetized Schirmer tests

    Time frame: Single dose: up to 10 days, Multiple dose: up to 20 days

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

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)

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 15, 2010
Registry last updated
Oct 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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