Back to resultsEvaluation of the Effect and Tolerance of Preservative Free NAAGA on the Inflammatory Component and Symptoms of Dry Eye Syndrome in Allergic Conjunctivitis Patients
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
NAABAK eyedrops
Saline eyedrops
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 20 years old
- Patients with dry eye syndrome in allergic conjunctivitis
Exclusion Criteria:
- Severe dry eye syndrome
- Severe ocular pathology
Sites / Locations
- Seoul National University Bundang Hospital
- Seoul National University Boramae Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Naaga in ABAK system
Saline solution
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01203540
First Posted
September 15, 2010
Last Updated
January 27, 2012
Sponsor
Laboratoires Thea
Collaborators
Samil Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01203540
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Laboratoires Thea
Collaborators
Samil Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
21 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Naaga in ABAK system
Arm Type
Experimental
Arm Title
Saline solution
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
NAABAK eyedrops
Intervention Type
Drug
Intervention Name(s)
Saline eyedrops
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 20 years old
Patients with dry eye syndrome in allergic conjunctivitis
Exclusion Criteria:
Severe dry eye syndrome
Severe ocular pathology
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
Country
Korea, Republic of
Facility Name
Seoul National University Boramae Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this 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
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