Efficacy and Safety Study of ATs in Patients With Dry Eye Syndrome

NCT00788229 | Completed Phase 2 DMC

• 1 other identifier: dhpat02
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether artificial tears are safe and effective in the treatment of Dry Eye Syndrome.

Conditions

Dry Eye Syndromes; Keratoconjunctivitis Sicca

Keywords

Dry Eye Syndromes; Keratoconjunctivitis Sicca; artificial tears; carboxymethylcellulose sodium; sodium hyaluronate

Outcome Measures

Primary Outcomes (1)

• Tear Break Up Time (TBUT)

  12weeks

Secondary Outcomes (1)

• Fluorescein staining, schirmer test, OSDI, VAS

  12 weeks

Study Arms (4)

1. Study Drugs

EXPERIMENTAL

Drug: AT01

2. Study Drug

EXPERIMENTAL

Drug: AT02

3. Study Drug

EXPERIMENTAL

Drug: AT03

4. Placebo

PLACEBO COMPARATOR

Drug: AT04

Interventions

AT01 DRUG

eye drop for 12 weeks

Also known as: DHP-101

1. Study Drugs

AT02 DRUG

eye drop for 12 weeks

Also known as: DHP-300

2. Study Drug

AT03 DRUG

eye drop for 12 weeks

Also known as: DHP-500

3. Study Drug

AT04 DRUG

eye drop for 12 weeks

Also known as: Saline

4. Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female adults aged 18 years and over.
• Subjects should diagnosed as dry eye syndrome in both eyes or one eye, keratoconjunctivitis sicca (KCS), or should have at least a 3-month history diagnosed as dry eye syndrome due to Sjögren syndrome.
• Subjects must agree to discontinue all artificial tears from Screening for 2 weeks
• Subjects must discontinue lens wear one week before Screening and agree not to wear contact lenses during the entire study.
• Subjects must provide signed informed consent prior to participation in any study-related procedures
• Subjects who dose not Participate in same clinical trial within 6 month prior to Screening.

You may not qualify if:

• Pregnancy or lactation.
• Females of childbearing potential who are not using systemic contraception,are not postmenopausal (≥ 1 year), or are not surgically sterilized.
• Ocular surgery (of any type, including laser surgery) or ocular trauma within the 4 months prior to Screening.
• Any active inflammation of the eye not due to KCS
• Other diseases or characteristics judged by the investigator to be incompatible with the assessments needed in this study or with reliable instillation of the study medication.

Sponsors & Collaborators

• Dhp Korea Co., Ltd.: lead

Study Sites (1)

Asan medical center

Seoul, 388-1 Pungnap-2dong, Songpa-gu, 138-736, South Korea

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Keratoconjunctivitis Sicca

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Hungwon Tchah,, MD

  Seoul asan medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 7, 2008
• First Posted: November 10, 2008
• Study Start: November 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: April 2, 2010

Record last verified: 2010-04

Locations

KR (1)