Allergic ConjunctivitisPhase 2NCT02079649

Safety and Efficacy Study of AL-53817 and AL-78843 Ophthalmic Solutions for Allergic Conjunctivitis

A Phase 2 study testing AL-53817 Ophthalmic Solution, 0.1%, AL-78843 Ophthalmic Solution, 0.03% and Dexamethasone Ophthalmic Suspension, 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

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Trial summary

The purpose of this study is to evaluate two investigational ophthalmic solutions for reduction in ocular redness in subjects with allergic conjunctivitis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Allergic Conjunctivitis
What is being tested?: AL-53817 Ophthalmic Solution, 0.1%, AL-78843 Ophthalmic Solution, 0.03% and Dexamethasone Ophthalmic Suspension, 0.1%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 224 participants
Where: No sites listed yet
Study dates: Apr 2014to Jul 2014
Phase: Phase 2
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Sign Informed Consent
Use of condom by sexually active males for the entire duration of the study.
Best corrected visual acuity of 55 or greater in each eye as measured by ETDRS (letters read method).
Able and willing to comply with study protocol and follow protocol instructions.
Able to avoid any of the topical ocular or systemic excluded medications during the entire study period.
At least 1 year subject-reported or physician-diagnosed history (prior to Screen Visit) of allergic conjunctivitis during the ragweed season.

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Positive skin prick test for short ragweed allergen within 12 months prior to Screen Visit.
Significant staff-assessed ocular redness in at least one region in each eye within the 3 hour period of allergen exposure in the EEC (Screen Visits).
Other protocol-defined inclusion criteria may apply.

Who cannot join

Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for at least 1 week following the last dose of investigational product.
Presence of any ocular infection, history of ocular Herpes (simplex or zoster) or adenoviral infection in either eye.
History of any ocular infection, physician or subject diagnosed, within 30 days prior to Screen Visit.
Presence of glaucoma, past history of, or diagnosis of glaucoma or ocular hypertension.
Presence of blepharitis, active rosacea affecting the ocular adnexa, meibomian gland dysfunction, follicular conjunctivitis, intraocular inflammation, or preauricular lymphadenopathy or any other ophthalmic abnormality that may affect the study outcomes.
Corneal conditions affecting the corneal structure.

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Unwilling to discontinue contact lens wear during the study period.
Any ocular surgery including ocular laser procedures within 1 year prior to Screen Visit.
Current or recent (<6 months prior to Screen Visit) history of severe, unstable, or uncontrolled autoimmune, neurological, cardiovascular, hematological, hepatic, renal, psychological, respiratory, gastrointestinal and/or immunological disease or evidence of other diseases based upon a review of medical history and/or physical examination that, in the opinion of the Investigator, would preclude safe subject participation in the study.
Receiving treatment for anxiety and/or depression at the Screen Visit; any history of suicide attempt.
Participation in any investigational study within 30 days of Screen Visit or concomitantly with this study.
Known contraindications or hypersensitivities to any of the study medications or their components
Confirmed (by physician or optometrist) diagnosis of dry eye.
History of sensitivity or adverse reaction to steroids.
Known allergic reaction that is unresponsive to corticosteroids or non-steroidal anti-inflammatory drugs (NSAIDS).
Physician diagnosed asthma (except inactive childhood asthma and exercise-induced asthma).
Evidence of active inflammation in the eye as determined by the dilated fundus examination conducted at Screen C Visit.
Any corneal swelling or haze as determined by the slitlamp examination conducted at Screen C Visit.
Other protocol-defined exclusion criteria may apply.

About this study

Official title: A Prospective, Randomized, Double-Masked, Vehicle and Active-Controlled, Safety and Efficacy Study of AL-53817 and AL-78843 Ophthalmic Solutions for the Treatment of Allergic Conjunctivitis in an Environmental Exposure Chamber (EEC) Model

The purpose of this study is to evaluate two investigational ophthalmic solutions for reduction in ocular redness in subjects with allergic conjunctivitis.

Read the detailed description

Eligible subjects attended 8 study visits, 5 of which included a 3-hour period of ragweed exposure in an Environmental Exposure Chamber. At the sixth visit, subjects received study product and began dosing for up to 9 days. The final visit was the final day of dosing. Participation in this study lasted up to 68 days.

Conditions: Allergic Conjunctivitis
Being tested: AL-53817 Ophthalmic Solution, 0.1%, AL-78843 Ophthalmic Solution, 0.03%, Dexamethasone Ophthalmic Suspension, 0.1%, AL-53817 Vehicle
Keywords: Allergic conjunctivitis, Red eyes, Eyelid swelling, Ragweed, Allergies, Itchy eyes, Ocular redness, Chemosis, Tearing, Watery eyes
Medical subject headings: Conjunctivitis, Allergic, Hypersensitivity, Lacerations

What participants receive

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

AL-53817 Ophthalmic Solution, 0.1%Drug
AL-78843 Ophthalmic Solution, 0.03%Drug
Dexamethasone Ophthalmic Suspension, 0.1%Drug
Also called Maxidex®
AL-53817 VehicleDrug
Inactive ingredients used for masking purposes

Study groups in NCT02079649
Study group	Role	What they receive
AL-53817	Experimental	AL-53817 Ophthalmic Solution, 0.1%, 1 drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9) Receives: Drug: AL-53817 Ophthalmic Solution, 0.1%
AL-78843	Experimental	AL-78843 Ophthalmic Solution, 0.03%, 1 drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9) Receives: Drug: AL-78843 Ophthalmic Solution, 0.03%
Maxidex	Active comparator	Dexamethasone Ophthalmic Suspension, 0.1%, 1 drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9) Receives: Drug: Dexamethasone Ophthalmic Suspension, 0.1%
Vehicle	Placebo comparator	AL-53817 Vehicle, 1 drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9) Receives: Drug: AL-53817 Vehicle

What is being measured

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

Mean Change From Baseline in Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7
Ocular redness ratings were collected for nasal and temporal areas of each eye and assessed by investigational center staff using a visual scale (ie, scored by comparing the subject's eye with a series of photographs) and graded on a scale from 0 (none) to 4 (extremely severe), 0.5 unit steps permitted. AUC was calculated using the trapezoidal rule with unequal intervals as determined by the assessment time points. Change was calculated as AUC(0-10)[Day 7] - AUC(0-10) [Baseline]. Both eyes contributed to the analysis.
Measured: 0.0, 0.25, 0.50, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, and 10.0 hours on Days 1 (baseline) and 7

Secondary outcomes (1)

Mean Change From Baseline in Ocular Itching, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7
Ocular itching was assessed by the subject with both eyes rated together and scored on a scale from 0 (none) to 4 (incapacitating itch with irresistible urge to rub). AUC was calculated using the trapezoidal rule with unequal intervals as determined by the assessment time points. Change was calculated as AUC(0-10)[Day 7] - AUC(0-10) [Baseline].
Measured: 0.0, 0.25, 0.50, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, and 10.0 hours on Days 1 (baseline) and 7

Timeline

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

Apr 2014Jul 2014

First posted6 Mar 2014 (estimated)
Study startApr 2014
Primary completionJul 2014
Study completionJul 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.
Publications (1)Papers the sponsor has linked to this study.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 224 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02079649
Sponsor's protocol ID: C-12-069
Status last verified: Aug 2015
First submitted: 4 Mar 2014
Last updated: 24 Aug 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Jacobs RL, Ramirez DA, Rather CG, Andrews CP, Jupiter DC, Trujillo F, Shulman DG. Redness response phenotypes of allergic conjunctivitis in an allergen challenge chamber. Ann Allergy Asthma Immunol. 2017 Jan;118(1):86-93.e2. doi: 10.1016/j.anai.2016.10.023.
PubMed 28007090

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

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Daydrop® Triple Action for Allergic Eye Symptoms
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An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
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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 24 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized, Double-Masked, Vehicle and Active-Controlled, Safety and Efficacy Study of AL-53817 and AL-78843 Ophthalmic Solutions for the Treatment of Allergic Conjunctivitis in an Environmental Exposure Chamber (EEC) Model
ClinicalTrials.gov ID: NCT02079649
Acronym / sponsor ID: C-12-069
Conditions: Allergic Conjunctivitis
Keywords: Allergic conjunctivitis, Red eyes, Eyelid swelling, Ragweed, Allergies, Itchy eyes, Ocular redness, Chemosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 224 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Apr 2014
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 6 Mar 2014 (estimated)
Results: Posted 6 Aug 2015

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 is to evaluate two investigational ophthalmic solutions for reduction in ocular redness in subjects with allergic conjunctivitis.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
AL-53817	Experimental	Drug: AL-53817 Ophthalmic Solution, 0.1%AL-53817 Ophthalmic Solution, 0.1%, 1 drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
AL-78843	Experimental	Drug: AL-78843 Ophthalmic Solution, 0.03%AL-78843 Ophthalmic Solution, 0.03%, 1 drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
Maxidex	Active comparator	Drug: Dexamethasone Ophthalmic Suspension, 0.1%Dexamethasone Ophthalmic Suspension, 0.1%, 1 drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
Vehicle	Placebo comparator	Drug: AL-53817 VehicleAL-53817 Vehicle, 1 drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)

Who may qualify

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

Key inclusion criteria (9 listed)

Sign Informed Consent
Use of condom by sexually active males for the entire duration of the study.
Best corrected visual acuity of 55 or greater in each eye as measured by ETDRS (letters read method).
Able and willing to comply with study protocol and follow protocol instructions.
Able to avoid any of the topical ocular or systemic excluded medications during the entire study period.

Key exclusion criteria (19 listed)

Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for at least 1 week following the last dose of investigational product.
Presence of any ocular infection, history of ocular Herpes (simplex or zoster) or adenoviral infection in either eye.
History of any ocular infection, physician or subject diagnosed, within 30 days prior to Screen Visit.
Presence of glaucoma, past history of, or diagnosis of glaucoma or ocular hypertension.
Presence of blepharitis, active rosacea affecting the ocular adnexa, meibomian gland dysfunction, follicular conjunctivitis, intraocular inflammation, or preauricular lymphadenopathy or any other ophthalmic abnormality that may affect the study outcomes.

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
AL-53817 Ophthalmic Solution, 0.1%	Drug	AL-53817
AL-78843 Ophthalmic Solution, 0.03%	Drug	AL-78843
Dexamethasone Ophthalmic Suspension, 0.1%Also: Maxidex®	Drug	Maxidex
AL-53817 VehicleInactive ingredients used for masking purposes	Drug	Vehicle

Primary outcome

Mean Change From Baseline in Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7
Time frame: 0.0, 0.25, 0.50, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, and 10.0 hours on Days 1 (baseline) and 7
Ocular redness ratings were collected for nasal and temporal areas of each eye and assessed by investigational center staff using a visual scale (ie, scored by comparing the subject's eye with a series of photographs) and graded on a scale from 0 (none) to 4 (extremely severe), 0.5 unit steps permitted. AUC was calculated using the trapezoidal rule with unequal intervals as determined by the assessment time points. Change was calculated as AUC(0-10)[Day 7] - AUC(0-10) [Baseline]. Both eyes contributed to the analysis.

1 secondary outcome

Mean Change From Baseline in Ocular Itching, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7
Time frame: 0.0, 0.25, 0.50, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, and 10.0 hours on Days 1 (baseline) and 7

Results and safety

Results posted to the registry on 6 Aug 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
AL-78843	42	41
AL-53817	41	41
Maxidex	41	40
Vehicle	40	38

Primary outcome: Mean Change From Baseline in Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7

Time frame: 0.0, 0.25, 0.50, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, and 10.0 hours on Days 1 (baseline) and 7. Mean (Standard Error). Unit: hours x units on a scale

Measure	AL-78843 n = 41	AL-53817 n = 41	Maxidex n = 40	Vehicle n = 38
Value	-2.8 (0.68)	-4.7 (0.68)	-8.1 (0.69)	-4.5 (0.70)

Population analysed: This analysis population includes all randomized subjects who had a baseline evaluation minus those who had important protocol deviations that could have affected the outcome of the study.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected for the duration of the study (April 2014 - July 2014). All AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pre-Treatment	0 of 224 (0%)	0 of 224 (0%)	Not reported
AL-78843	0 of 41 (0%)	0 of 41 (0%)	Not reported
AL-53817	0 of 41 (0%)	0 of 41 (0%)	Not reported
Maxidex	0 of 40 (0%)	0 of 40 (0%)	Not reported
Vehicle	0 of 40 (0%)	0 of 40 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28007090Jacobs RL, Ramirez DA, Rather CG, Andrews CP, Jupiter DC, Trujillo F, Shulman DG. Redness response phenotypes of allergic conjunctivitis in an allergen challenge chamber. Ann Allergy Asthma Immunol. 2017 Jan;118(1):86-93.e2. doi: 10.1016/j.anai.2016.10.023.

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
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Recruiting
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RecruitingObservational study
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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.

Clinical Trial Manager, Pharma, GCRA study director

Alcon Research

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 9 inclusion and 19 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 24 Aug 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 6 Aug 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 Change From Baseline in Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7 (time frame: 0.0, 0.25, 0.50, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, and 10.0 hours on Days 1 (baseline) and 7). 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 NCT02079649, which also lists 1 linked publication.

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 24 Aug 2015.