Conjunctivitis, AllergicNCT01987765

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

An observational study of Conjunctivitis, Allergic, run by Allergan at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Conjunctivitis, Allergic
What is being tested?: Relestat Ophthalmic Solution 0.05%
How many people: 847 participants
Where: 1 siteSouth Korea
Study dates: Jan 2009to Sep 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients with Allergic Conjunctivitis treated with Relestat Ophthalmic Solution in clinical practice.

Who may be able to join

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

Who cannot join

None.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Study site
Gangwon-do

Other trials in South Korea

About this study

Conditions: Conjunctivitis, Allergic
Being tested: Relestat Ophthalmic Solution 0.05%
Medical subject headings: Conjunctivitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Relestat Ophthalmic Solution 0.05%Drug
Relestat Ophthalmic Solution 0.05% prescribed as local standard of care in clinical practice.

Study groups in NCT01987765
Study group	Role	What they receive
Relestat Ophthalmic Solution 0.05%		Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice. Receives: Drug: Relestat Ophthalmic Solution 0.05%

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Patients Reporting Adverse Events
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.
Measured: Up to 10 Months
Change From Baseline in Eye Symptoms Total Score on a 4-Point Scale
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.
Measured: Baseline, 2 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009Sep 2012

First posted19 Nov 2013 (estimated)
Study startJan 2009
Primary completionSep 2012
Study completionSep 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Conjunctivitis, AllergicStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 847 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01987765
Sponsor's protocol ID: 198027-A
Status last verified: Mar 2014
First submitted: 13 Nov 2013
Last updated: 29 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Adult and Pediatric Participants With Allergic Conjunctivitis Due to Cat Allergy
Allergic Conjunctivitis
Recruiting
Daydrop® Triple Action for Allergic Eye Symptoms
Allergic Conjunctivitis of Both Eyes
RecruitingPhase 3
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
Persistent Corneal Epithelial Defect
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
RecruitingObservational study
Treatment of Ocular Surface Inflammations
Ocular Surface Allergy, Conjunctivitis, Allergic

All Conjunctivitis, Allergic trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Relestat Ophthalmic Solution 0.05% for Allergic Conjunctivitis in Korea
ClinicalTrials.gov ID: NCT01987765
Acronym / sponsor ID: 198027-A
Conditions: Conjunctivitis, Allergic
Study type: Observational
Recruitment status: Completed
Enrolment: 847 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 19 Nov 2013 (estimated)
Results: Posted 29 Apr 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Relestat Ophthalmic Solution 0.05%	–	Drug: Relestat Ophthalmic Solution 0.05%Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients with Allergic Conjunctivitis treated with Relestat Ophthalmic Solution in clinical practice.

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

None.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Relestat Ophthalmic Solution 0.05%Relestat Ophthalmic Solution 0.05% prescribed as local standard of care in clinical practice.	Drug	Relestat Ophthalmic Solution 0.05%

Primary outcome

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.

Results and safety

Results posted to the registry on 29 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Relestat Ophthalmic Solution 0.05%	847	745

Primary outcome: Percentage of Patients Reporting Adverse Events

Time frame: Up to 10 Months. Number. Unit: Percentage of Patients

Measure	Relestat Ophthalmic Solution 0.05% n = 745
Value	0.13

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

Primary outcome: Change From Baseline in Eye Symptoms Total Score on a 4-Point Scale

Time frame: Baseline, 2 Weeks. Mean (Standard Deviation). Unit: Scores on a Scale

Measure	Relestat Ophthalmic Solution 0.05% n = 741
Baseline	5.58 (2.25)
Change from Baseline at 2 Weeks	-4.06 (2.17)

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

Adverse events

Time frame: Adverse events were collected during follow-up, for a period of up to 10 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Relestat Ophthalmic Solution 0.05%	0 of 745 (0%)	0 of 745 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Conjunctivitis, Allergic

RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Adult and Pediatric Participants With Allergic Conjunctivitis Due to Cat Allergy
Allergic Conjunctivitis
Recruiting
Daydrop® Triple Action for Allergic Eye Symptoms
Allergic Conjunctivitis of Both Eyes
RecruitingPhase 3
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
Persistent Corneal Epithelial Defect
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
RecruitingObservational study
Treatment of Ocular Surface Inflammations
Ocular Surface Allergy, Conjunctivitis, Allergic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Allergan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Conjunctivitis, Allergic, run by Allergan at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients Reporting Adverse Events (time frame: Up to 10 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01987765.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2014.