NCT01203540

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2010

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

January 31, 2012

Status Verified

January 1, 2012

First QC Date

September 15, 2010

Last Update Submit

January 27, 2012

Conditions

Allergic Conjunctivitis

Study Arms (2)

Naaga in ABAK system

EXPERIMENTAL
Drug: NAABAK eyedrops

Saline solution

PLACEBO COMPARATOR
Drug: Saline eyedrops

Interventions

NAABAK eyedropsDRUG
Naaga in ABAK system
Saline eyedropsDRUG
Saline solution

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Severe dry eye syndrome
  • Severe ocular pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Location

Seoul National University Boramae Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 15, 2010

First Posted

September 16, 2010

Study Start

October 1, 2010

Study Completion

January 1, 2011

Last Updated

January 31, 2012

Record last verified: 2012-01

Locations

KR(2)