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NCT01203540 Clinical Trial

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

Allergic Conjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01203540
Other study ID # NBKE_SNUBH&BM_01
Secondary ID LT0455-IST-01/10
Status Completed
Phase Phase 4
First received September 15, 2010
Last updated January 27, 2012
Start date October 2010
Est. completion date January 2011

Study information
Verified date January 2012
Source Laboratoires Thea
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date January 2011
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Age = 20 years old

- Patients with dry eye syndrome in allergic conjunctivitis

Exclusion Criteria:

- Severe dry eye syndrome

- Severe ocular pathology

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• NAABAK eyedrops

• Saline eyedrops

Locations
Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si
Korea, Republic of Seoul National University Boramae Medical Center Seoul

Sponsors (2)
Lead Sponsor Collaborator
Laboratoires Thea Samil Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

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