Allergic ConjunctivitisPhase 4NCT01282138

Assessment of Alcon's Ocular Image Quantification System

A Phase 4 study testing Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol) and Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II) in people with Allergic Conjunctivitis, run by Alcon Research at 1 site in United States.

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

The purpose of this study was to evaluate ocular responses with different allergen provocation methods. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Allergic Conjunctivitis
What is being tested?: Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol) and Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 13 participants
Where: 1 siteUnited States
Study dates: Dec 2010to Mar 2011
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

History of allergic conjunctivitis;
Active signs and symptoms of ocular allergies;
Other protocol-defined inclusion criteria may apply.

Who cannot join

History of dry eye;
Presence of ocular infection;
Presence of severe or serious ocular conditions;
Symptoms of allergic conjunctivitis;
Use of topical or systemic ocular medications as specified in protocol;
Ocular surgery or laser surgery within 6 months of study start;
Unwilling to discontinue contact lens wear 72 hours prior to Visit 1 and during study period;
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134

Other trials in United States

About this study

Official title: A Study to Assess Alcon's Ocular Image Quantification Using Conjunctival Allergan Provocation Testing (CAPT) and Natural Allergen Exposure in an Environmental Exposure Chamber (EEC)

The purpose of this study was to evaluate ocular responses with different allergen provocation methods.

Read the detailed description

Subjects demonstrating a successful allergen response to a common allergen received the first study treatment and used as instructed for 5 days, after which they entered the Environmental Exposure Chamber (EEC) for a 3-hour exposure to a known concentration of the allergen. After waiting at least 7 days, subjects received the second study treatment and used as instructed for 5 days, after which a 3-hour Conjunctival Allergen Provocation Test (CAPT) was performed with an escalating concentration of the allergen. Subjects dosed with study treatment approximately 15 minutes prior to each allergen provocation test.

Conditions: Allergic Conjunctivitis
Being tested: Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol), Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II)
Keywords: Allergic conjunctivitis
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 hydrochloride, 0.1% ophthalmic solution (Patanol)Drug
Also called Patanol®
One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.
Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II)Other
Also called Tears Naturale II
One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.

Study groups in NCT01282138
Study group	Role	What they receive
Patanol	Experimental	One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing. Receives: Drug: Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol)
Tears Naturale II	Placebo comparator	One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing. Receives: Other: Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II)

What is being measured

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

Change From Baseline in Patient-Assessed Ocular Itching, Environmental Exposure Chamber (EEC), at 3 Hours
As assessed by the participant after 3 hours in the EEC. Ocular itching was graded on a 0-4 scale, where 0=none, 1=tickling sensation involving one or more corners of the eye, 2=all over tickling sensation; 3=moderate continuous itching with desire to rub; 4=severe itching with irresistible urge to rub.
Measured: Baseline, 3 hours
Change From Baseline in Patient-Assessed Ocular Itching, Conjunctival Allergen Provocation Test (CAPT), at 3 Hours
As assessed by the participant after 3 hours of CAPT. Ocular itching was graded on a 0-4 scale, where 0=none, 1=tickling sensation involving one or more corners of the eye, 2=all over tickling sensation; 3=moderate continuous itching with desire to rub; 4=severe itching with irresistible urge to rub.
Measured: Baseline, 3 hours

Timeline

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

Dec 2010Mar 2011

First posted24 Jan 2011 (estimated)
Study startDec 2010
Primary completionMar 2011
Study completionMar 2011

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.
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: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01282138
Sponsor's protocol ID: RDG-10-278
Status last verified: Jul 2012
First submitted: 20 Jan 2011
Last updated: 18 Dec 2012
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

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All Allergic Conjunctivitis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Assess Alcon's Ocular Image Quantification Using Conjunctival Allergan Provocation Testing (CAPT) and Natural Allergen Exposure in an Environmental Exposure Chamber (EEC)
ClinicalTrials.gov ID: NCT01282138
Acronym / sponsor ID: RDG-10-278
Conditions: Allergic Conjunctivitis
Keywords: Allergic conjunctivitis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Dec 2010
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 24 Jan 2011 (estimated)
Results: Posted 25 Jul 2012

Clinical summary

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

The purpose of this study was to evaluate ocular responses with different allergen provocation methods.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Patanol	Experimental	Drug: Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol)One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
Tears Naturale II	Placebo comparator	Other: Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II)One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

History of allergic conjunctivitis;
Active signs and symptoms of ocular allergies;
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (8 listed)

History of dry eye;
Presence of ocular infection;
Presence of severe or serious ocular conditions;
Symptoms of allergic conjunctivitis;
Use of topical or systemic ocular medications as specified in 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 hydrochloride, 0.1% ophthalmic solution (Patanol)Also: Patanol®One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.	Drug	Patanol
Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II)Also: Tears Naturale IIOne drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.	Other	Tears Naturale II

Primary outcome

Change From Baseline in Patient-Assessed Ocular Itching, Environmental Exposure Chamber (EEC), at 3 Hours
Time frame: Baseline, 3 hours
As assessed by the participant after 3 hours in the EEC. Ocular itching was graded on a 0-4 scale, where 0=none, 1=tickling sensation involving one or more corners of the eye, 2=all over tickling sensation; 3=moderate continuous itching with desire to rub; 4=severe itching with irresistible urge to rub.
Change From Baseline in Patient-Assessed Ocular Itching, Conjunctival Allergen Provocation Test (CAPT), at 3 Hours
Time frame: Baseline, 3 hours
As assessed by the participant after 3 hours of CAPT. Ocular itching was graded on a 0-4 scale, where 0=none, 1=tickling sensation involving one or more corners of the eye, 2=all over tickling sensation; 3=moderate continuous itching with desire to rub; 4=severe itching with irresistible urge to rub.

Results and safety

Results posted to the registry on 25 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patanol	6	6
Tears Naturale II	7	7

Primary outcome: Change From Baseline in Patient-Assessed Ocular Itching, Environmental Exposure Chamber (EEC), at 3 Hours

Time frame: Baseline, 3 hours. Mean (Standard Error). Unit: Units on a scale

Measure	Patanol n = 6	Tears Naturale II n = 7
Value	-1.63 (0.6)	-1.11 (0.2)

Population analysed: All enrolled participants

Primary outcome: Change From Baseline in Patient-Assessed Ocular Itching, Conjunctival Allergen Provocation Test (CAPT), at 3 Hours

Time frame: Baseline, 3 hours. Mean (Standard Error). Unit: Units on a scale

Measure	Patanol n = 6	Tears Naturale II n = 7
Value	-0.38 (0.6)	-1.15 (0.5)

Population analysed: All enrolled participants

Adverse events

Time frame: Adverse events were collected for the duration of the study: 3 months, 1 week, 6 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patanol	0 of 6 (0%)	0 of 6 (0%)	Not reported
Tears Naturale II	0 of 7 (0%)	2 of 7 (28.6%)	Not reported

Limitations and caveats (from the sponsor): This was a pilot study with a small number of subjects not adequately powered to detect treatment differences.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Allergic Conjunctivitis

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
Recruiting
Daydrop® Triple Action for Allergic Eye Symptoms
Allergic Conjunctivitis of Both Eyes
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
RecruitingObservational study
Treatment of Ocular Surface Inflammations
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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 8 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 18 Dec 2012. 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 United States. 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. Some participants in this study may receive a placebo. 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 25 Jul 2012). 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 Patient-Assessed Ocular Itching, Environmental Exposure Chamber (EEC), at 3 Hours (time frame: Baseline, 3 hours). 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 NCT01282138.

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 18 Dec 2012.