Allergic ConjunctivitisPhase 3NCT01551056

A Multi-Center Study Evaluating the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle in the Conjunctival Allergen Challenge (CAC)

A Phase 3 study testing AC-170 0.24% and AC-170 0% in people with Allergic Conjunctivitis, run by Aciex Therapeutics, Inc. 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 is to evaluate the onset and duration of action of AC-170 0.24% compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in the conjunctival allergen challenge (CAC) model. 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?: AC-170 0.24% and AC-170 0%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 91 participants
Where: 1 siteUnited States
Study dates: Mar 2012to Jun 2012
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

positive bilateral conjunctival allergen challenge (CAC) reaction

Who cannot join

known contraindications or sensitivities to the study medication or its components
any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters
use of disallowed medication during the period indicated prior to the enrollment or during the study

Trial locations and contacts

1 site in 1 country.

United States1 site

Ora, Inc.
Andover, Massachusetts, 01810

Other trials in United States

About this study

Official title: A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Evaluation of the Onset and Duration of Action of Cetirizine 0.24% Ophthalmic Solution (Formula AFH-002) Compared to Vehicle (Formula AFH-001) in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis

Conditions: Allergic Conjunctivitis
Being tested: AC-170 0.24%, AC-170 0%
Medical subject headings: Conjunctivitis, Allergic

What participants receive

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

AC-170 0.24%Drug
1 drop in each eye at 2 separate times during a 14 day period
AC-170 0%Drug
1 drop in each eye at 2 separate times during a 14 day period

Study groups in NCT01551056
Study group	Role	What they receive
AC-170 0.24%	Experimental	Not described Receives: Drug: AC-170 0.24%
AC-170 0%	Placebo comparator	Not described Receives: Drug: AC-170 0%

What is being measured

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

Ocular Itching at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy Conjunctival Allergen Challenge (CAC) was performed 16 hours + 1 hour after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Measured: 3, 5, 7 minutes post-CAC
Ocular Itching at Onset of Action (15 Minutes Post-dose)
A treatment efficacy CAC was performed 15 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Measured: 3, 5, 7 minutes post-CAC
Conjunctival Redness at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.
Measured: 7, 15, 20 minutes post-CAC
Conjunctival Redness at Onset of Action (15 Minutes Post-dose)
A treatment efficacy CAC was performed 15 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.
Measured: 7, 15, 20 minutes post-CAC

Secondary outcomes (21)

Ciliary Redness at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.
Measured: 7, 15, 20 minutes post-CAC
Ciliary Redness at Onset of Action (15 Minutes Post-dose)
A treatment efficacy CAC was performed 15 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.
Measured: 7, 15, 20 minutes post-CAC
Episcleral Redness at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.
Measured: 7, 15, 20 minutes post-CAC
Episcleral Redness at Onset of Action (15 Minutes Post-dose)
A treatment efficacy CAC was performed 15 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.
Measured: 7, 15, 20 minutes post-CAC
Chemosis at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.
Measured: 7, 15, 20 minutes post-CAC
Chemosis at Onset of Action (15 Minutes Post-dose)
A treatment efficacy CAC was performed 15 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.
Measured: 7, 15, 20 minutes post-CAC
Eyelid Swelling at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.
Measured: 7, 15, 20 minutes post-CAC
Eyelid Swelling at Onset of Action (15 Minutes Post-dose)
A treatment efficacy CAC was performed 15 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.
Measured: 7, 15, 20 minutes post-CAC
Tearing at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.
Measured: 7, 15, 20 minutes post-CAC
Tearing at Onset of Action (15 Minutes Post-dose)
A treatment efficacy CAC was performed 15 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.
Measured: 7, 15, 20 minutes post-CAC
Rhinorrhea at Duration of Action (16 Hours +1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.
Measured: 7, 15, 20 minutes post-CAC
Rhinorrhea at Onset of Action (15 Minutes Post-dose)
A treatment efficacy CAC was performed 15 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.
Measured: 7, 15, 20 minutes post-CAC
Nasal Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.
Measured: 7, 15, 20 minutes post-CAC
Nasal Pruritis at Onset of Action (15 Minutes Post-dose)
A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.
Measured: 7, 15, 20 minutes post-CAC
Ear or Palate Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.
Measured: 7, 15, 20 minutes post-CAC
Ear or Palate Pruritis at Onset of Action (15 Minutes Post-dose)
A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.
Measured: 7, 15, 20 minutes post-CAC
Nasal Congestion at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.
Measured: 7, 15, 20 minutes post-CAC
Nasal Congestion at Onset of Action (15 Minutes Post-dose)
A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.
Measured: 7, 15, 20 minutes post-CAC
Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Duration of Action (16 Hours + 1 Hour Post-dose)
A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.
Measured: 7, 15, 20 minutes post-CAC
Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Onset of Action (15 Minutes Post-dose)
A treatment efficacy CAC was performed 15 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.
Measured: 7, 15, 20 minutes post-CAC
Tolerability of Study Medication at Visit 3A
Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.
Measured: upon instillation, 1 minute and 2 minutes post instillation

Timeline

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

Mar 2012Jun 2012

First posted12 Mar 2012 (estimated)
Study startMar 2012
Primary completionJun 2012
Study completionJun 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 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01551056
Sponsor's protocol ID: 11-100-0012
Status last verified: Oct 2017
First submitted: 8 Mar 2012
Last updated: 7 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?

See locations

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RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
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RecruitingPhase 3
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All Allergic Conjunctivitis trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Evaluation of the Onset and Duration of Action of Cetirizine 0.24% Ophthalmic Solution (Formula AFH-002) Compared to Vehicle (Formula AFH-001) in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis
ClinicalTrials.gov ID: NCT01551056
Acronym / sponsor ID: 11-100-0012
Conditions: Allergic Conjunctivitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: Aciex Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: Mar 2012
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 12 Mar 2012 (estimated)
Results: Posted 3 Oct 2017

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: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
AC-170 0.24%	Experimental	Drug: AC-170 0.24%
AC-170 0%	Placebo comparator	Drug: AC-170 0%

Who may qualify

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

Key inclusion criteria (1 listed)

positive bilateral conjunctival allergen challenge (CAC) reaction

Key exclusion criteria (3 listed)

known contraindications or sensitivities to the study medication or its components
any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters
use of disallowed medication during the period indicated prior to the enrollment or during the study

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
AC-170 0.24%1 drop in each eye at 2 separate times during a 14 day period	Drug	AC-170 0.24%
AC-170 0%1 drop in each eye at 2 separate times during a 14 day period	Drug	AC-170 0%

Primary outcome

Ocular Itching at Duration of Action (16 Hours + 1 Hour Post-dose)
Time frame: 3, 5, 7 minutes post-CAC
A treatment efficacy Conjunctival Allergen Challenge (CAC) was performed 16 hours + 1 hour after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Ocular Itching at Onset of Action (15 Minutes Post-dose)
Time frame: 3, 5, 7 minutes post-CAC
A treatment efficacy CAC was performed 15 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Conjunctival Redness at Duration of Action (16 Hours + 1 Hour Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.
Conjunctival Redness at Onset of Action (15 Minutes Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
A treatment efficacy CAC was performed 15 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.

21 secondary outcomes

Ciliary Redness at Duration of Action (16 Hours + 1 Hour Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
Ciliary Redness at Onset of Action (15 Minutes Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
Episcleral Redness at Duration of Action (16 Hours + 1 Hour Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
Episcleral Redness at Onset of Action (15 Minutes Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
Chemosis at Duration of Action (16 Hours + 1 Hour Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
Chemosis at Onset of Action (15 Minutes Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
Eyelid Swelling at Duration of Action (16 Hours + 1 Hour Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
Eyelid Swelling at Onset of Action (15 Minutes Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
Tearing at Duration of Action (16 Hours + 1 Hour Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
Tearing at Onset of Action (15 Minutes Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
Rhinorrhea at Duration of Action (16 Hours +1 Hour Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
Rhinorrhea at Onset of Action (15 Minutes Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
Nasal Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
Nasal Pruritis at Onset of Action (15 Minutes Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
Ear or Palate Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
Ear or Palate Pruritis at Onset of Action (15 Minutes Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
Nasal Congestion at Duration of Action (16 Hours + 1 Hour Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
Nasal Congestion at Onset of Action (15 Minutes Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Duration of Action (16 Hours + 1 Hour Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Onset of Action (15 Minutes Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
Tolerability of Study Medication at Visit 3A
Time frame: upon instillation, 1 minute and 2 minutes post instillation

Results and safety

Results posted to the registry on 3 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AC-170 0.24%	46	44
AC-170 0%	45	45

Primary outcome: Ocular Itching at Duration of Action (16 Hours + 1 Hour Post-dose)

Time frame: 3, 5, 7 minutes post-CAC. Mean (Standard Deviation). Unit: units on a scale

Measure	AC-170 0.24% n = 46	AC-170 0% n = 45
3 minutes post-CAC	1.71 (0.886)	2.34 (0.720)
5 minutes post-CAC	1.88 (0.910)	2.50 (0.644)
7 minutes post-CAC	1.76 (0.944)	2.22 (0.875)

Population analysed: Intent to Treat (ITT)

Primary outcome: Ocular Itching at Onset of Action (15 Minutes Post-dose)

Time frame: 3, 5, 7 minutes post-CAC. Mean (Standard Deviation). Unit: units on a scale

Measure	AC-170 0.24% n = 46	AC-170 0% n = 45
3 minutes post-CAC	0.71 (0.638)	2.18 (0.979)
5 minutes post-CAC	1.01 (0.691)	2.31 (0.980)
7 minutes post-CAC	1.00 (0.783)	2.10 (0.998)

Population analysed: Intent to Treat (ITT)

Primary outcome: Conjunctival Redness at Duration of Action (16 Hours + 1 Hour Post-dose)

Time frame: 7, 15, 20 minutes post-CAC. Mean (Standard Deviation). Unit: units on a scale

Measure	AC-170 0.24% n = 46	AC-170 0% n = 45
7 minutes post-CAC	1.72 (0.771)	1.94 (0.796)
15 minutes post-CAC	1.96 (0.777)	2.02 (0.788)
20 minutes post-CAC	1.92 (0.780)	1.98 (0.759)

Population analysed: Intent to Treat (ITT)

Primary outcome: Conjunctival Redness at Onset of Action (15 Minutes Post-dose)

Time frame: 7, 15, 20 minutes post-CAC. Mean (Standard Deviation). Unit: units on a scale

Measure	AC-170 0.24% n = 46	AC-170 0% n = 45
7 minutes post-CAC	2.02 (0.728)	2.05 (0.714)
15 minutes post-CAC	2.23 (0.667)	2.13 (0.736)
20 minutes post-CAC	2.28 (0.644)	2.18 (0.762)

Population analysed: Intent to Treat (ITT)

21 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected through the duration of the study, over the course of approximately 3 months. All subjects who received study medication were evaluable for the safety analysis.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AC-170 0.24%	0 of 46 (0%)	1 of 46 (2.2%)	Not reported
AC-170 0%	0 of 45 (0%)	5 of 45 (11.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Allergic Conjunctivitis

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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.

Jack Greiner, DO principal investigator

Charles River Eye Associates

Gail Torkildsen principal investigator

Andover Eye Associates

Stacey Ackerman, MD principal investigator

Philadelphia Eye Associates

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AC-170 0.24% and AC-170 0% in people with Allergic Conjunctivitis, run by Aciex Therapeutics, Inc. at 1 site in United States.

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 3 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 Nov 2017. 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 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 3 Oct 2017). 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?

Ocular Itching at Duration of Action (16 Hours + 1 Hour Post-dose) (time frame: 3, 5, 7 minutes post-CAC). The study lists 4 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 NCT01551056.

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 Nov 2017.