Evaluation of the Effect and Tolerance of Preservative Free NAAGA on the Inflammatory Component and Symptoms of Dry Eye Syndrome in Allergic Conjunctivitis Patients
Sponsor
Laboratoires Thea (Industry)
Overall Status
Completed
CT.gov ID
NCT01203540
Collaborator
Samil Pharmaceutical Co., Ltd. (Industry)
21
2
2
3
10.5
3.5
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
21 participants
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
Study Start Date
:
Oct 1, 2010
Actual Study Completion Date
:
Jan 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Naaga in ABAK system
|
Drug: NAABAK eyedrops
|
| Placebo Comparator: Saline solution
|
Drug: Saline eyedrops
|
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
and Older
Sexes Eligible for Study:
All
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Bundang Hospital | Seongnam-si | Korea, Republic of | ||
| 2 | Seoul National University Boramae Medical Center | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Laboratoires Thea
- Samil Pharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT01203540
Other Study ID Numbers:
- NBKE_SNUBH&BM_01
- LT0455-IST-01/10
First Posted:
Sep 16, 2010
Last Update Posted:
Jan 31, 2012
Last Verified:
Jan 1, 2012
Additional relevant MeSH terms: