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

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01987765
• Collaborator: (none)
• Enrollment: 847
• Location: 1
• Duration (Months): 44
• Patients Per Site Per Month: 19.3

Study Details

Study Description

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	Phase
Conjunctivitis, Allergic	Drug: Relestat Ophthalmic Solution 0.05%

Study Design

• Study Type: Observational
• Actual Enrollment: 847 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Percentage of Patients Reporting Adverse Events [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• None.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Gangwon-do		Korea, Republic of

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01987765
• Other Study ID Numbers: 198027-A
• First Posted: Nov 19, 2013
• Last Update Posted: Apr 29, 2014
• Last Verified: Mar 1, 2014

• Additional relevant MeSH terms: Conjunctivitis; Conjunctivitis, Allergic; Ophthalmic Solutions

Study Results

Participant Flow

Arm/Group Title	Relestat Ophthalmic Solution 0.05%
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

Baseline Characteristics

Arm/Group Title	Relestat Ophthalmic Solution 0.05%
Arm/Group Description	Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
Overall Participants	745
Age, Customized (Number) [Number]
<20 years	143 19.2%
20 to 29 years	129 17.3%
30 to 39 years	139 18.7%
40 to 49 years	127 17%
50 to 59 years	84 11.3%
60 to 69 years	73 9.8%
≥70 years	50 6.7%
Sex: Female, Male (Count of Participants)
Female	487 65.4%
Male	258 34.6%

Outcome Measures

1. Primary Outcome

Title	Percentage of Patients Reporting Adverse Events
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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Relestat Ophthalmic Solution 0.05%
Arm/Group Description	Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
Measure Participants	745
Number [Percentage of Patients]	0.13

2. Primary Outcome

Title	Change From Baseline in Eye Symptoms Total Score on a 4-Point Scale
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

Outcome Measure Data

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%
Arm/Group Description	Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
Measure Participants	741
Baseline	5.58 (2.25)
Change from Baseline at 2 Weeks	-4.06 (2.17)

Adverse Events

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%
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Relestat Ophthalmic Solution 0.05%
	Affected / at Risk (%)	# Events
Total	0/745 (0%)
Other (Not Including Serious) Adverse Events
	Relestat Ophthalmic Solution 0.05%
	Affected / at Risk (%)	# Events
Total	0/745 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.