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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

Tracking Information
First Submitted Date November 13, 2013
First Posted Date November 19, 2013
Results First Submitted Date March 26, 2014
Results First Posted Date April 29, 2014
Last Update Posted Date April 29, 2014
Study Start Date January 2009
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 26, 2014)
  • 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.
  • 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.
Original Primary Outcome Measures
 (submitted: November 13, 2013)
Eye Symptoms Evaluation using a 4-Point Scale [ Time Frame: 2 Weeks ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Safety and Efficacy of Relestat Ophthalmic Solution 0.05% for Allergic Conjunctivitis in Korea
Official Title Not Provided
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with Allergic Conjunctivitis treated with Relestat Ophthalmic Solution in clinical practice.
Condition Conjunctivitis, Allergic
Intervention Drug: Relestat Ophthalmic Solution 0.05%
Relestat Ophthalmic Solution 0.05% prescribed as local standard of care in clinical practice.
Study Groups/Cohorts Relestat Ophthalmic Solution 0.05%
Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
Intervention: Drug: Relestat Ophthalmic Solution 0.05%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 13, 2013)
847
Original Actual Enrollment Same as current
Actual Study Completion Date September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01987765
Other Study ID Numbers 198027-A
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Allergan
Study Sponsor Allergan
Collaborators Not Provided
Investigators
Study Director: Medical Director Allergan
PRS Account Allergan
Verification Date March 2014