Safety and Efficacy of Relestat Ophthalmic Solution 0.05% for Allergic Conjunctivitis in Korea

Conjunctivitis, Allergic Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01987765
• Other study ID #: 198027-A
• Status: Completed
• Phase: N/A
• First received: November 13, 2013
• Last updated: March 26, 2014
• Start date: January 2009
• Est. completion date: September 2012

Study information

• Verified date: March 2014
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and efficacy of Relestat Ophthalmic Solution 0.05% in patients with allergic conjunctivitis who are treated with Relestat as standard of care in clinical practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 847
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with Allergic Conjunctivitis treated with Relestat Ophthalmic Solution in clinical practice.

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• Relestat Ophthalmic Solution 0.05%
Relestat Ophthalmic Solution 0.05% prescribed as local standard of care in clinical practice.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients Reporting Adverse Events	An adverse event is any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.	Up to 10 Months	No
Primary	Change From Baseline in Eye Symptoms Total Score on a 4-Point Scale	Itchiness, conjunctival hyperaemia (redness), lacrimation (tearing), and foreign body sensation were each evaluated on a 4-point scale ranging from 0 (best) to 3 (worst). The eye symptom total score is the sum of the individual symptom scores and ranges from 0 (best) to 12 (worst). A negative number change from baseline indicates an improvement.	Baseline, 2 Weeks	No