Allergic ConjunctivitisPhase 3NCT02322216

Olopatadine Hydrochloride Ophthalmic Solution Study in Chinese Subjects

A Phase 3 study testing Olopatadine Hydrochloride Ophthalmic Solution 0.2% and Olopatadine Hydrochloride Ophthalmic Solution 0.1% 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

Search all trials

Trial summary

The purpose of this study is to evaluate olopatadine 0.2% QD (once per day) compared to olopatadine 0.1% BID (twice per day) in the treatment of ocular itching associated with allergic conjunctivitis. Read more about this study

Who is it for?: Ages 10 years and older
Conditions the study is for: Allergic Conjunctivitis
What is being tested?: Olopatadine Hydrochloride Ophthalmic Solution 0.2% and Olopatadine Hydrochloride Ophthalmic Solution 0.1%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 383 participants
Where: No sites listed yet
Study dates: Dec 2014to Oct 2015
Phase: Phase 3
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 10 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Chinese ethnicity;
History of allergic conjunctivitis within the last 2 years;
Positive skin prick test or skin intradermal test documented by a lab report within 24 months of, or at the baseline visit;
Clinical diagnosis of allergic conjunctivitis with specific signs and symptoms;
Understand and sign an informed consent form;
Willing and able to make required study visits and follow study instructions, and comply with dosing study medication as instructed;
Other protocol-specified inclusion criteria may apply.

Who cannot join

Contraindications or hypersensitivity to study medications or their components;
Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to approximately 0.60 logMAR, 20/80 Snellen, or 0.25 decimal) in either eye;
Any ocular condition that could affect the study outcomes;
Presumed or actual ocular infection or history of ocular herpes in either eye;
Known history of retinal detachment, diabetic retinopathy, or any progressive retinal disease;
Willing and able to avoid the use of any other topical ocular medication(s) (including artificial tear products);

Show all 17Show fewer

Any significant illness that could be expected to interfere with the study, particularly any autoimmune disease;
Intraocular surgery in either eye within 6 months, or ocular laser surgery in either eye within 3 months, or anticipation of ocular surgery during the study; ocular trauma in either eye within 3 months of baseline visit;
Clinically relevant recent (within 6 months of baseline visit) history of or current severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, autoimmune disease and other relevant systemic diseases that would preclude the safe administration of a topical antihistamine/mast cell stabilizer in the opinion of the Investigator;
Use of systemic medication(s) on a chronic dosing regimen for less than 1 month or have changed dosage within the month prior to baseline visit;
Use of any disallowed medication (topical, topical ophthalmic, systemic and/or injectable) during the period indicated prior to baseline visit. These medications are also not allowed during the study. Disallowed medications include all anti-allergy therapies including those contained in prescription or over-the-counter sleeping aids;
Use of cold compresses on the eyes during the course of the study;
Cannot be dosed in both eyes;
Cannot avoid contact lens wear during the course of the study;
Therapy with another investigational agent within 30 days of baseline visit, or during the study;
Women of childbearing potential who are pregnant, intend to become pregnant during the study period, breast-feeding, or not using adequate birth control methods;
Other protocol-specified exclusion criteria may apply.

About this study

Official title: A Comparative Study of Olopatadine Hydrochloride Ophthalmic Solution 0.2% QD vs Olopatadine Hydrochloride Ophthalmic Solution 0.1% BID in the Treatment of Allergic Conjunctivitis in Chinese Subjects

Conditions: Allergic Conjunctivitis
Being tested: Olopatadine Hydrochloride Ophthalmic Solution 0.2%, Olopatadine Hydrochloride Ophthalmic Solution 0.1%, Olopatadine 0.2% Vehicle
Keywords: Allergies, Ocular
Medical subject headings: Conjunctivitis, Allergic, Hypersensitivity

What participants receive

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

Olopatadine Hydrochloride Ophthalmic Solution 0.2%Drug
Also called PATADAY®
Olopatadine Hydrochloride Ophthalmic Solution 0.1%Drug
Also called PATANOL®
Olopatadine 0.2% VehicleDrug
Inactive ingredients used as placebo comparator

Study groups in NCT02322216
Study group	Role	What they receive
PATADAY	Experimental	Olopatadine hydrochloride ophthalmic solution 0.2% in the morning and olopatadine 0.2% vehicle in the evening, 1 drop in each eye for 14 days Receives: Drug: Olopatadine Hydrochloride Ophthalmic Solution 0.2%; Drug: Olopatadine 0.2% Vehicle
PATANOL	Active comparator	Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days Receives: Drug: Olopatadine Hydrochloride Ophthalmic Solution 0.1%

What is being measured

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

Change From Baseline in Worst Ocular Itching Score During the 24 Hours Prior at Day 14
Severity of ocular itching was evaluated as the worst score observed in the past 24 hours prior to each study visit. Ocular itching was assessed by the participant on a scale from 0-4, where 0=None and 4=Incapacitating itch. One eye (study eye) contributed to the analysis.
Measured: Baseline, Day 14

Timeline

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

Dec 2014Oct 2015

First posted23 Dec 2014 (estimated)
Study startDec 2014
Primary completionOct 2015
Study completionOct 2015

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 383 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02322216
Sponsor's protocol ID: C-12-010 (EXC458-C001)
Other IDs: 2016-004317-27, 2016
Status last verified: Oct 2017
First submitted: 17 Dec 2014
Last updated: 17 Nov 2017
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
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 Allergic Conjunctivitis trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparative Study of Olopatadine Hydrochloride Ophthalmic Solution 0.2% QD vs Olopatadine Hydrochloride Ophthalmic Solution 0.1% BID in the Treatment of Allergic Conjunctivitis in Chinese Subjects
ClinicalTrials.gov ID: NCT02322216
Acronym / sponsor ID: C-12-010 (EXC458-C001)
Conditions: Allergic Conjunctivitis
Keywords: Allergies, Ocular
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 383 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Dec 2014
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 23 Dec 2014 (estimated)
Results: Posted 12 Oct 2016

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: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
PATADAY	Experimental	Drug: Olopatadine Hydrochloride Ophthalmic Solution 0.2%, Drug: Olopatadine 0.2% VehicleOlopatadine hydrochloride ophthalmic solution 0.2% in the morning and olopatadine 0.2% vehicle in the evening, 1 drop in each eye for 14 days
PATANOL	Active comparator	Drug: Olopatadine Hydrochloride Ophthalmic Solution 0.1%Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days

Who may qualify

Ages: 10 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

Chinese ethnicity;
History of allergic conjunctivitis within the last 2 years;
Positive skin prick test or skin intradermal test documented by a lab report within 24 months of, or at the baseline visit;
Clinical diagnosis of allergic conjunctivitis with specific signs and symptoms;
Understand and sign an informed consent form;

Key exclusion criteria (17 listed)

Contraindications or hypersensitivity to study medications or their components;
Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to approximately 0.60 logMAR, 20/80 Snellen, or 0.25 decimal) in either eye;
Any ocular condition that could affect the study outcomes;
Presumed or actual ocular infection or history of ocular herpes in either eye;
Known history of retinal detachment, diabetic retinopathy, or any progressive retinal disease;

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 Hydrochloride Ophthalmic Solution 0.2%Also: PATADAY®	Drug	PATADAY
Olopatadine Hydrochloride Ophthalmic Solution 0.1%Also: PATANOL®	Drug	PATANOL
Olopatadine 0.2% VehicleInactive ingredients used as placebo comparator	Drug	PATADAY

Primary outcome

Change From Baseline in Worst Ocular Itching Score During the 24 Hours Prior at Day 14
Time frame: Baseline, Day 14
Severity of ocular itching was evaluated as the worst score observed in the past 24 hours prior to each study visit. Ocular itching was assessed by the participant on a scale from 0-4, where 0=None and 4=Incapacitating itch. One eye (study eye) contributed to the analysis.

Results and safety

Results posted to the registry on 12 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PATADAY	126	124
PATANOL	127	123

Primary outcome: Change From Baseline in Worst Ocular Itching Score During the 24 Hours Prior at Day 14

Time frame: Baseline, Day 14. Mean (Standard Error). Unit: units on a scale

Measure	PATADAY n = 118	PATANOL n = 112
Value	-2.57 (0.090)	-2.62 (0.092)

Population analysed: Per Protocol Set with non-missing data

Adverse events

Time frame: Adverse events (AEs) were collected from the time of informed consent and for the duration of participation in the study (2 weeks). This analysis group includes all participants who received study treatment. Ocular adverse events are presented for both study eye and non-study eye combined. AEs are reported as pre-treatment and treatment-emergent.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pre-treatment	0 of 383 (0%)	0 of 383 (0%)	Not reported
PATADAY	0 of 126 (0%)	0 of 126 (0%)	Not reported
PATANOL	0 of 126 (0%)	0 of 126 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
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.

Master, Clinical Medicine study director

Alcon (China) Ophthalmic Product Co., Ltd.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Olopatadine Hydrochloride Ophthalmic Solution 0.2% and Olopatadine Hydrochloride Ophthalmic Solution 0.1% 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 7 inclusion and 17 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 17 Nov 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 12 Oct 2016). 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?

Change From Baseline in Worst Ocular Itching Score During the 24 Hours Prior at Day 14 (time frame: Baseline, Day 14). 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 NCT02322216.

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 17 Nov 2017.