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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01203540
First Posted: September 16, 2010
Last Update Posted: January 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Samil Pharmaceutical Co., Ltd.
Information provided by:
Laboratoires Thea
  Purpose

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
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01203540


Locations
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

ClinicalTrials.gov Identifier: NCT01203540     History of Changes
Other Study ID Numbers: NBKE_SNUBH&BM_01
LT0455-IST-01/10
First Submitted: September 15, 2010
First Posted: September 16, 2010
Last Update Posted: January 31, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Conjunctivitis
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Lacrimal Apparatus Diseases
Keratoconjunctivitis
Keratitis
Corneal Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ophthalmic Solutions
Tetrahydrozoline
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents