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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

This study has been completed.
Samil Pharmaceutical Co., Ltd.
Information provided by:
Laboratoires Thea Identifier:
First received: September 15, 2010
Last updated: January 27, 2012
Last verified: January 2012

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.

Condition Intervention Phase
Allergic Conjunctivitis
Drug: NAABAK eyedrops
Drug: Saline eyedrops
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Laboratoires Thea:

Estimated Enrollment: 21
Study Start Date: October 2010
Study Completion Date: January 2011
Arms Assigned Interventions
Experimental: Naaga in ABAK system Drug: NAABAK eyedrops
Placebo Comparator: Saline solution Drug: Saline eyedrops


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Severe dry eye syndrome
  • Severe ocular pathology
  Contacts and Locations
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Please refer to this study by its identifier: NCT01203540

Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Korea, Republic of
Seoul National University Boramae Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Laboratoires Thea
Samil Pharmaceutical Co., Ltd.
  More Information Identifier: NCT01203540     History of Changes
Other Study ID Numbers: NBKE_SNUBH&BM_01  LT0455-IST-01/10 
Study First Received: September 15, 2010
Last Updated: January 27, 2012
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Lacrimal Apparatus Diseases
Corneal Diseases
Hypersensitivity, Immediate
Immune System Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents processed this record on October 21, 2016