Trial Outcomes & Findings for Safety and Efficacy of Relestat Ophthalmic Solution 0.05% for Allergic Conjunctivitis in Korea (NCT NCT01987765)

NCT ID: NCT01987765

Last Updated: 2014-04-29

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 847 participants
• Primary outcome timeframe: Up to 10 Months
• Results posted on: 2014-04-29

Participant Flow

Participant milestones

Measure	Relestat Ophthalmic Solution 0.05% Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
Overall Study STARTED	847
Overall Study COMPLETED	745
Overall Study NOT COMPLETED	102

Reasons for withdrawal

Measure	Relestat Ophthalmic Solution 0.05% Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
Overall Study Protocol Violation	65
Overall Study Lost to Follow-up	37

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Relestat Ophthalmic Solution 0.05% n=745 Participants Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
Age, Customized <20 years	143 Participants n=5 Participants
Age, Customized 20 to 29 years	129 Participants n=5 Participants
Age, Customized 30 to 39 years	139 Participants n=5 Participants
Age, Customized 40 to 49 years	127 Participants n=5 Participants
Age, Customized 50 to 59 years	84 Participants n=5 Participants
Age, Customized 60 to 69 years	73 Participants n=5 Participants
Age, Customized ≥70 years	50 Participants n=5 Participants
Sex: Female, Male Female	487 Participants n=5 Participants
Sex: Female, Male Male	258 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 10 Months

Population: Safety Assessment Population: included all patients who completed the study.

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.

Outcome measures

Measure	Relestat Ophthalmic Solution 0.05% n=745 Participants Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
Percentage of Patients Reporting Adverse Events	0.13 Percentage of Patients

PRIMARY outcome

Timeframe: Baseline, 2 Weeks

Population: Efficacy Assessment Population: included all patients in the Safety Assessment Population whose data was available for analysis.

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.

Outcome measures

Measure	Relestat Ophthalmic Solution 0.05% n=741 Participants Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
Change From Baseline in Eye Symptoms Total Score on a 4-Point Scale Baseline	5.58 Scores on a Scale Standard Deviation 2.25
Change From Baseline in Eye Symptoms Total Score on a 4-Point Scale Change from Baseline at 2 Weeks	-4.06 Scores on a Scale Standard Deviation 2.17

Adverse Events

Relestat Ophthalmic Solution 0.05%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vice President GSE,

Allergan, Inc

Phone: 714-246-4500

Email: clinicaltrials@allergan.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER