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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01987765
Recruitment Status : Completed
First Posted : November 19, 2013
Results First Posted : April 29, 2014
Last Update Posted : April 29, 2014
Sponsor:
Information provided by (Responsible Party):
Allergan

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.

Condition or disease Intervention/treatment
Conjunctivitis, Allergic Drug: Relestat Ophthalmic Solution 0.05%

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Study Type : Observational
Actual Enrollment : 847 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : January 2009
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye

Group/Cohort Intervention/treatment
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%
Relestat Ophthalmic Solution 0.05% prescribed as local standard of care in clinical practice.




Primary Outcome Measures :
  1. Percentage of Patients Reporting Adverse Events [ Time Frame: Up to 10 Months ]
    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.

  2. Change From Baseline in Eye Symptoms Total Score on a 4-Point Scale [ Time Frame: Baseline, 2 Weeks ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Allergic Conjunctivitis treated with Relestat Ophthalmic Solution in clinical practice.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01987765


Locations
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Korea, Republic of
Gangwon-do, Korea, Republic of
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01987765    
Other Study ID Numbers: 198027-A
First Posted: November 19, 2013    Key Record Dates
Results First Posted: April 29, 2014
Last Update Posted: April 29, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ophthalmic Solutions
Pharmaceutical Solutions