Allergic ConjunctivitisPhase 4NCT02251613

Effectiveness of Olopatadine HCl Ophthalmic Solution for the Treatment of Allergic Conjunctivitis in Japan

A Phase 4 study testing Olopatadine HCl ophthalmic solution, 0.1% and Epinastine HCl ophthalmic solution, 0.05% in people with Allergic Conjunctivitis, run by Alcon Research.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 20 years and older
Conditions the study is for: Allergic Conjunctivitis
What is being tested?: Olopatadine HCl ophthalmic solution, 0.1% and Epinastine HCl ophthalmic solution, 0.05%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: No sites listed yet
Study dates: Dec 2013to Jan 2014
Phase: Phase 4
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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Be Japanese and live in Japan;
History of allergic conjunctivitis;
Positive skin test reaction to Japanese cedar at Visit 1;
Positive bilateral CAC reaction to the allergen at Visit 1 and Visit 2;
Able and willing to avoid all disallowed medications during the specified period;
Able to discontinue wearing contact lenses during the specified period;
Sign Informed Consent;
Other protocol-defined inclusion criteria may apply.

Who cannot join

History of hypersensitivity to the study drug or compounds;
Any ocular condition that, in the opinion of the investigator, could affect the patient's safety;
Ocular surgical intervention within 3 months or refractive surgery within 6 months prior to the start of the study;
Presence of active ocular infection;
Use of disallowed medications as specified in the protocol;
Pregnant, nursing, or planning to become pregnant during the study;
Other protocol-defined exclusion criteria may apply.

About this study

Official title: Effectiveness of Olopatadine HCl Ophthalmic Solution, 0.1% Compared to Epinastine HCl Ophthalmic Solution, 0.05% in the Treatment of Allergic Conjunctivitis to Japanese Cedar Pollen

The purpose of this study is to evaluate the effectiveness and safety of Olopatadine Hydrochloride (HCl) ophthalmic solution 0.1% versus Epinastine HCl ophthalmic solution, 0.05% in a population of healthy, adult Japanese patients (20 years of age or older) with a history of allergic conjunctivitis to Japanese Cedar Pollen. Patients will be randomly assigned to receive Olopatadine HCl ophthalmic solution, 0.1% in one eye and Epinastine HCl ophthalmic solution, 0.05% in the fellow eye, after which a conjunctival allergy challenge (CAC) with Japanese cedar pollen will be performed.

Conditions: Allergic Conjunctivitis
Being tested: Olopatadine HCl ophthalmic solution, 0.1%, Epinastine HCl 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.

Olopatadine HCl ophthalmic solution, 0.1%Drug
Also called PATANOL®
Epinastine HCl ophthalmic solution, 0.05%Drug

Study groups in NCT02251613
Study group	Role	What they receive
Olopatadine (right or left, randomized)	Experimental	Olopatadine HCl ophthalmic solution, 0.1%, 1 drop in the right or left eye as randomized Receives: Drug: Olopatadine HCl ophthalmic solution, 0.1%
Epinastine (fellow eye)	Active comparator	Epinastine HCl ophthalmic solution, 0.05%, 1 drop in the in the fellow eye Receives: Drug: Epinastine HCl ophthalmic solution, 0.05%

What is being measured

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

Mean Ocular Itching at 7 Minutes Post-CAC, Day 1
A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Ocular itching was assessed by the patient for each eye at 7 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=incapacitating itch with irresistible urge to rub).
Measured: Day 1, 7 minutes post-CAC

Secondary outcomes (1)

Mean Conjunctival Hyperemia at 20 Minutes Post-CAC, Day 1
A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Conjunctival hyperemia (redness) was evaluated by the investigator based on biomicroscopy for each eye at 20 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=extremely severe).
Measured: Day 1, 20 minutes post-CAC

Timeline

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

Dec 2013Jan 2014

First posted29 Sep 2014 (estimated)
Study startDec 2013
Primary completionJan 2014
Study completionJan 2014

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 Allergic ConjunctivitisStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe sponsor's other registered studies.
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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02251613
Sponsor's protocol ID: 13-100-0009
Other IDs: UMIN000013943
Status last verified: Oct 2015
First submitted: 25 Sep 2014
Last updated: 7 Oct 2015
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?

Official record

RecruitingPhase 3
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Daydrop® Triple Action for Allergic Eye Symptoms
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RecruitingPhase 3
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
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RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
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All Allergic Conjunctivitis trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Olopatadine HCl Ophthalmic Solution, 0.1% Compared to Epinastine HCl Ophthalmic Solution, 0.05% in the Treatment of Allergic Conjunctivitis to Japanese Cedar Pollen
ClinicalTrials.gov ID: NCT02251613
Acronym / sponsor ID: 13-100-0009
Conditions: Allergic Conjunctivitis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Dec 2013
Primary completion: Jan 2014 (actual)
Study completion: Jan 2014 (actual)
First posted: 29 Sep 2014 (estimated)
Results: Posted 9 Feb 2015

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Olopatadine (right or left, randomized)	Experimental	Drug: Olopatadine HCl ophthalmic solution, 0.1%Olopatadine HCl ophthalmic solution, 0.1%, 1 drop in the right or left eye as randomized
Epinastine (fellow eye)	Active comparator	Drug: Epinastine HCl ophthalmic solution, 0.05%Epinastine HCl ophthalmic solution, 0.05%, 1 drop in the in the fellow eye

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Be Japanese and live in Japan;
History of allergic conjunctivitis;
Positive skin test reaction to Japanese cedar at Visit 1;
Positive bilateral CAC reaction to the allergen at Visit 1 and Visit 2;
Able and willing to avoid all disallowed medications during the specified period;

Key exclusion criteria (7 listed)

History of hypersensitivity to the study drug or compounds;
Any ocular condition that, in the opinion of the investigator, could affect the patient's safety;
Ocular surgical intervention within 3 months or refractive surgery within 6 months prior to the start of the study;
Presence of active ocular infection;
Use of disallowed medications as specified in the protocol;

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
Olopatadine HCl ophthalmic solution, 0.1%Also: PATANOL®	Drug	Olopatadine (right or left, randomized)
Epinastine HCl ophthalmic solution, 0.05%	Drug	Epinastine (fellow eye)

Primary outcome

Mean Ocular Itching at 7 Minutes Post-CAC, Day 1
Time frame: Day 1, 7 minutes post-CAC
A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Ocular itching was assessed by the patient for each eye at 7 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=incapacitating itch with irresistible urge to rub).

1 secondary outcome

Mean Conjunctival Hyperemia at 20 Minutes Post-CAC, Day 1
Time frame: Day 1, 20 minutes post-CAC

Results and safety

Results posted to the registry on 9 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall	50	50

Primary outcome: Mean Ocular Itching at 7 Minutes Post-CAC, Day 1

Time frame: Day 1, 7 minutes post-CAC. Mean (Standard Deviation). Unit: units on a scale

Measure	Olopatadine 0.1% n = 50	Epinastine 0.05% n = 50
Value	0.23 (0.31)	0.37 (0.44)

Population analysed: This analysis population includes all randomized participants.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected for the duration of the study (December, 2013 - January, 2014). This analysis group includes all randomized subjects who received at least 1 dose of study medication.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Olopatadine 0.1%	0 of 50 (0%)	0 of 50 (0%)	Not reported
Epinastine 0.05%	0 of 50 (0%)	0 of 50 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Allergic Conjunctivitis

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.

Tsunemitsu Senta study director

Alcon Japan, Ltd.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Olopatadine HCl ophthalmic solution, 0.1% and Epinastine HCl ophthalmic solution, 0.05% in people with Allergic Conjunctivitis, run by Alcon Research.

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 8 inclusion and 7 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 7 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Feb 2015). 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?

Mean Ocular Itching at 7 Minutes Post-CAC, Day 1 (time frame: Day 1, 7 minutes post-CAC). 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 NCT02251613.

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 7 Oct 2015.