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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:
Collaborator:
Samil Pharmaceutical Co., Ltd.
Information provided by:
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT01203540
First received: September 15, 2010
Last updated: January 27, 2012
Last verified: January 2012
  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-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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 15, 2010
Last Updated: January 27, 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

ClinicalTrials.gov processed this record on June 23, 2017