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

NCT01987765 | Completed Results

• 1 other identifier: 198027-A
• Study Type: observational
• Target: 847
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Conjunctivitis, Allergic

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Relestat Ophthalmic Solution 0.05%

Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.

Drug: Relestat Ophthalmic Solution 0.05%

Interventions

Relestat Ophthalmic Solution 0.05% DRUG

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

Relestat Ophthalmic Solution 0.05%

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• None.

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Gangwon-do, South Korea

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Vice President GSE,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: November 19, 2013
• Study Start: January 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: April 29, 2014
• Results First Posted: April 29, 2014

Record last verified: 2014-03

Locations

KR (1)