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Evaluation of the Effect and Tolerance of Preservative Free NAAGA on the Inflammatory Component and Symptoms of Dry Eye Syndrome in Allergic Conjunctivitis Patients

NCT ID: NCT01203540

Last Updated: 2012-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-01-31

Brief Summary

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Multicentre, Double blind, Randomized, Comparative Study(comparing N-acetyl-aspartyl-glutamic acid(NAAGA) in Abak preservative free device versus SALINE in Abak preservative free device.

Evaluation of the effects and safety of NAABAK® through inflammation markers and symptoms in patients with allergic conjunctivitis and dry eye syndrome after 3 months treatment.

The patients will attend 4 visits.

Detailed Description

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Conditions

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Allergic Conjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Naaga in ABAK system

Group Type EXPERIMENTAL

NAABAK eyedrops

Intervention Type DRUG

Saline solution

Group Type PLACEBO_COMPARATOR

Saline eyedrops

Intervention Type DRUG

Interventions

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NAABAK eyedrops

Intervention Type DRUG

Saline eyedrops

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 20 years old
* Patients with dry eye syndrome in allergic conjunctivitis

Exclusion Criteria

* Severe dry eye syndrome
* Severe ocular pathology
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samil Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Laboratoires Thea

INDUSTRY

Sponsor Role lead

Locations

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Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Site Status

Seoul National University Boramae Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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LT0455-IST-01/10

Identifier Type: -

Identifier Source: secondary_id

NBKE_SNUBH&BM_01

Identifier Type: -

Identifier Source: org_study_id