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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

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Conjunctivitis, Allergic
Intervention Drug: Relestat Ophthalmic Solution 0.05%
Enrollment 847
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Relestat Ophthalmic Solution 0.05%
Hide Arm/Group Description Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
Period Title: Overall Study
Started 847
Completed 745
Not Completed 102
Reason Not Completed
Protocol Violation             65
Lost to Follow-up             37
Arm/Group Title Relestat Ophthalmic Solution 0.05%
Hide Arm/Group Description Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
Overall Number of Baseline Participants 745
Hide Baseline Analysis Population Description
The Safety Assessment Population which included all patients who completed the study, was used for the analysis of baseline characteristics.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 745 participants
<20 years 143
20 to 29 years 129
30 to 39 years 139
40 to 49 years 127
50 to 59 years 84
60 to 69 years 73
≥70 years 50
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 745 participants
Female
487
  65.4%
Male
258
  34.6%
1.Primary Outcome
Title Percentage of Patients Reporting Adverse Events
Hide Description 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.
Time Frame Up to 10 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Assessment Population: included all patients who completed the study.
Arm/Group Title Relestat Ophthalmic Solution 0.05%
Hide Arm/Group Description:
Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
Overall Number of Participants Analyzed 745
Measure Type: Number
Unit of Measure: Percentage of Patients
0.13
2.Primary Outcome
Title Change From Baseline in Eye Symptoms Total Score on a 4-Point Scale
Hide Description 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.
Time Frame Baseline, 2 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Assessment Population: included all patients in the Safety Assessment Population whose data was available for analysis.
Arm/Group Title Relestat Ophthalmic Solution 0.05%
Hide Arm/Group Description:
Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
Overall Number of Participants Analyzed 741
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 5.58  (2.25)
Change from Baseline at 2 Weeks -4.06  (2.17)
Time Frame Adverse events were collected during follow-up, for a period of up to 10 months.
Adverse Event Reporting Description The Safety Assessment Population was used to assess adverse events (AEs) and serious adverse events (SAE). The Safety Assessment Population included all patients who completed the study.
 
Arm/Group Title Relestat Ophthalmic Solution 0.05%
Hide Arm/Group Description Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
All-Cause Mortality
Relestat Ophthalmic Solution 0.05%
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Relestat Ophthalmic Solution 0.05%
Affected / at Risk (%)
Total   0/745 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Relestat Ophthalmic Solution 0.05%
Affected / at Risk (%)
Total   0/745 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is at least 30 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vice President GSE,
Organization: Allergan, Inc
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01987765    
Other Study ID Numbers: 198027-A
First Submitted: November 13, 2013
First Posted: November 19, 2013
Results First Submitted: March 26, 2014
Results First Posted: April 29, 2014
Last Update Posted: April 29, 2014