Allergic ConjunctivitisPhase 2NCT01134328

Efficacy of AC-150 for the Treatment of Allergic Conjunctivitis in the Enviro-CAC™ Model

A Phase 2 study testing AC-150 Combo, AC-150A 0.1% and AC-150B 0.005% 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 efficacy of AC-150 compared to vehicle and its components in the prevention of the signs and symptoms of allergic conjunctivitis in Enviro-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-150 Combo, AC-150A 0.1% and AC-150B 0.005%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 83 participants
Where: 1 siteUnited States
Study dates: May 2010to Jul 2010
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 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 medications during the period indicated prior to study 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, Randomized, Double-Masked Evaluation of the Efficacy of Cetirizine 0.1%/Fluticasone 0.005% Ophthalmic Solution Compared to Its Components and Vehicle in a Modified Conjunctival Allergen Challenge (CAC) Model During Pollen Season

The purpose of this study is to evaluate the efficacy of AC-150 compared to vehicle and its components in the prevention of the signs and symptoms of allergic conjunctivitis in Enviro-CAC™ Model.

Conditions: Allergic Conjunctivitis
Being tested: AC-150 Combo, AC-150A 0.1%, AC-150B 0.005%, Vehicle
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-150 ComboDrug
1 drop in each eye for up to 14 days
AC-150A 0.1%Drug
1 drop in each eye once per day for up to 14 days
AC-150B 0.005%Drug
1 drop in each eye once per day for up to 14 days
VehicleDrug
1 drop in each eye once per day for up to 14 days

Study groups in NCT01134328
Study group	Role	What they receive
AC-150 Combo	Experimental	Not described Receives: Drug: AC-150 Combo
AC-150A 0.1%	Active comparator	Not described Receives: Drug: AC-150A 0.1%
AC-150B 0.005%	Active comparator	Not described Receives: Drug: AC-150B 0.005%
Vehicle	Other	Not described Receives: Drug: Vehicle

What is being measured

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

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
Ocular Itching at Duration of Action (16 Hours Post-dose)
A treatment efficacy CAC was performed 16 hours 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 8 Hours Post-dose at Visit 4A
A treatment efficacy CAC was performed 8 hours 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 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
Conjunctival Redness at Duration of Action (16 Hours Post-dose)
A treatment efficacy CAC was performed 16 hours 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 8 Hours Post-dose at Visit 4A
A treatment efficacy CAC was performed 8 hours 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 (17)

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
Ciliary Redness at Duration of Action (16 Hours Post-dose)
A treatment efficacy CAC was performed 16 hours 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 8 Hours Post-dose at Visit 4A
A treatment efficacy CAC was performed 8 hours 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 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
Episcleral Redness at Duration of Action (16 Hours Post-dose)
A treatment efficacy CAC was performed 16 hours 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 8 Hours Post-dose at Visit 4A
A treatment efficacy CAC was performed 8 hours 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
Total Redness at Onset of Action (15 Minutes Post-dose)
A treatment efficacy CAC was performed 15 minutes after drop instillation. Total redness was defined as the sum of the conjunctival, ciliary and episcleral redness scores, and was, thus, on a 0-12 scale, making the threshold for clinical significance a treatment difference of 3.0 units. Higher scores represent greater severity.
Measured: 7, 15, 20 minutes post-CAC
Total Redness at Duration of Action (16 Hours Post-dose)
A treatment efficacy CAC was performed 16 hours after drop instillation. Total redness was defined as the sum of the conjunctival, ciliary and episcleral redness scores, and was, thus, on a 0-12 scale, making the threshold for clinical significance a treatment difference of 3.0 units. Higher scores represent greater severity.
Measured: 7, 15, 20 minutes post-CAC
Total Redness at 8 Hours Post-Dose at Visit 4A
A treatment efficacy CAC was performed 8 hours after drop instillation. Total redness was defined as the sum of the conjunctival, ciliary and episcleral redness scores, and was, thus, on a 0-12 scale, making the threshold for clinical significance a treatment difference of 3.0 units. Higher scores represent greater severity.
Measured: 7, 15, 20 minutes post-CAC
Lid Swelling at Onset of Action (15 Minutes Post-dose)
A treatment efficacy CAC was performed 15 minutes after drop instillation. Lid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of lid swelling score over both eyes was analyzed.
Measured: 7, 15, 20 minutes post-CAC
Lid Swelling Duration of Action (16 Hours Post-dose)
A treatment efficacy CAC was performed 16 hours after drop instillation. Lid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of lid swelling score over both eyes was analyzed.
Measured: 7, 15, 20 minutes post-CAC
Lid Swelling at 8 Hours Post-dose at Visit 4A
A treatment efficacy CAC was performed 8 hours after drop instillation. Lid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of lid swelling score over both eyes was analyzed.
Measured: 7, 15, 20 minutes post-CAC
Ear or Palate Pruritus 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
Ear or Palate Pruritus at Duration of Action (16 Hours 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
Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A
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
Tolerability of Study Medication at Visit 2B
Subjects were asked to rate the comfort of the drop in each eye upon instillation, at 1 minute, and at 2 minutes after instillation of study medication. The assessment used a 10-point scale with 0 as very comfortable and 10 as very uncomfortable. Higher scores represent a worse outcome.
Measured: upon instillation, 1 minute and 2 minutes post instillation
Tolerability of Study Medication at Visit 3
Subjects were asked to rate the comfort of the drop in each eye upon instillation, at 1 minute, and at 2 minutes after instillation of study medication. The assessment used a 10-point scale with 0 as very comfortable and 10 as very uncomfortable. Higher scores represent a worse outcome.
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.

May 2010Jul 2010

First posted2 Jun 2010 (estimated)
Study startMay 2010
Primary completionJul 2010
Study completionJul 2010

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 83 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01134328
Sponsor's protocol ID: 10-100-0005
Status last verified: Sep 2017
First submitted: 28 May 2010
Last updated: 14 Sep 2017
Results posted: Yes, on ClinicalTrials.gov

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 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Randomized, Double-Masked Evaluation of the Efficacy of Cetirizine 0.1%/Fluticasone 0.005% Ophthalmic Solution Compared to Its Components and Vehicle in a Modified Conjunctival Allergen Challenge (CAC) Model During Pollen Season
ClinicalTrials.gov ID: NCT01134328
Acronym / sponsor ID: 10-100-0005
Conditions: Allergic Conjunctivitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 83 participants (actual)
Lead sponsor: Aciex Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: May 2010
Primary completion: Jul 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 2 Jun 2010 (estimated)
Results: Posted 14 Sep 2017

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 the efficacy of AC-150 compared to vehicle and its components in the prevention of the signs and symptoms of allergic conjunctivitis in Enviro-CAC™ Model.

Study design

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

Arm	Type	Receives
AC-150 Combo	Experimental	Drug: AC-150 Combo
AC-150A 0.1%	Active comparator	Drug: AC-150A 0.1%
AC-150B 0.005%	Active comparator	Drug: AC-150B 0.005%
Vehicle	Other	Drug: Vehicle

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 medications during the period indicated prior to study 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-150 Combo1 drop in each eye for up to 14 days	Drug	AC-150 Combo
AC-150A 0.1%1 drop in each eye once per day for up to 14 days	Drug	AC-150A 0.1%
AC-150B 0.005%1 drop in each eye once per day for up to 14 days	Drug	AC-150B 0.005%
Vehicle1 drop in each eye once per day for up to 14 days	Drug	Vehicle

Primary outcome

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.
Ocular Itching at Duration of Action (16 Hours Post-dose)
Time frame: 3, 5, 7 minutes post-CAC
A treatment efficacy CAC was performed 16 hours 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 8 Hours Post-dose at Visit 4A
Time frame: 3, 5, 7 minutes post-CAC
A treatment efficacy CAC was performed 8 hours 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 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.
Conjunctival Redness at Duration of Action (16 Hours Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
A treatment efficacy CAC was performed 16 hours 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 8 Hours Post-dose at Visit 4A
Time frame: 7, 15, 20 minutes post-CAC
A treatment efficacy CAC was performed 8 hours 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.

17 secondary outcomes

Ciliary Redness at Onset of Action (15 Minutes Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
Ciliary Redness at Duration of Action (16 Hours Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
Ciliary Redness at 8 Hours Post-dose at Visit 4A
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
Episcleral Redness at Duration of Action (16 Hours Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
Episcleral Redness at 8 Hours Post-dose at Visit 4A
Time frame: 7, 15, 20 minutes post-CAC
Total Redness at Onset of Action (15 Minutes Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
Total Redness at Duration of Action (16 Hours Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
Total Redness at 8 Hours Post-Dose at Visit 4A
Time frame: 7, 15, 20 minutes post-CAC
Lid Swelling at Onset of Action (15 Minutes Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
Lid Swelling Duration of Action (16 Hours Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
Lid Swelling at 8 Hours Post-dose at Visit 4A
Time frame: 7, 15, 20 minutes post-CAC
Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A
Time frame: 7, 15, 20 minutes post-CAC
Tolerability of Study Medication at Visit 2B
Time frame: upon instillation, 1 minute and 2 minutes post instillation
Tolerability of Study Medication at Visit 3
Time frame: upon instillation, 1 minute and 2 minutes post instillation

Results and safety

Results posted to the registry on 14 Sep 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-150 Combo	21	19
AC-150A 0.1%	21	18
AC-150B 0.005%	20	17
Vehicle	21	17

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-150 Combo n = 20	AC-150A 0.1% n = 20	AC-150B 0.005% n = 19	Vehicle n = 19
3 minutes post-CAC	1.33 (0.974)	0.99 (0.752)	2.11 (1.173)	2.90 (0.967)
5 minutes post-CAC	1.44 (1.076)	1.33 (0.590)	2.25 (1.057)	3.11 (0.944)
7 minutes post-CAC	1.31 (1.033)	1.59 (0.894)	2.03 (1.131)	2.97 (1.018)

Population analysed: Intent to Treat (ITT)

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

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

Measure	AC-150 Combo n = 20	AC-150A 0.1% n = 19	AC-150B 0.005% n = 18	Vehicle n = 18
3 minutes post-CAC	1.75 (1.112)	1.92 (1.131)	1.88 (1.082)	3.04 (0.693)
5 minutes post-CAC	1.95 (1.160)	2.24 (0.991)	2.21 (1.132)	3.18 (0.706)
7 minutes post-CAC	1.98 (1.067)	2.12 (1.156)	2.11 (1.231)	3.18 (0.727)

Population analysed: Intent to Treat (ITT) Population with Last Observation Carried Forward (LOCF)

Primary outcome: Ocular Itching at 8 Hours Post-dose at Visit 4A

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

Measure	AC-150 Combo n = 20	AC-150A 0.1% n = 19	AC-150B 0.005% n = 18	Vehicle n = 18
3 minutes post-CAC	1.43 (1.007)	1.53 (0.916)	2.01 (0.872)	2.99 (0.627)
5 minutes post-CAC	1.56 (1.022)	1.83 (0.954)	2.17 (0.899)	2.90 (0.703)
7 minutes post-CAC	1.64 (1.071)	1.86 (0.925)	2.03 (0.935)	2.79 (0.792)

Population analysed: Intent to Treat (ITT) Population with Last Observation Carried Forward (LOCF)

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-150 Combo n = 20	AC-150A 0.1% n = 19	AC-150B 0.005% n = 18	Vehicle n = 18
7 minutes post-CAC	1.70 (0.677)	1.97 (0.812)	2.18 (0.835)	2.49 (0.639)
15 minutes post-CAC	2.04 (0.704)	2.25 (0.997)	2.44 (0.770)	2.58 (0.733)
20 minutes post-CAC	2.04 (0.745)	2.37 (0.980)	2.51 (0.838)	2.58 (0.733)

Population analysed: Intent to Treat (ITT) Population with Last Observation Carried Forward (LOCF)

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected through the completion of the study, approximately two months. All subjects who received study medication were evaluable for the safety analysis.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AC-150 Combo	0 of 21 (0%)	0 of 21 (0%)	Not reported
AC-150A 0.1%	0 of 21 (0%)	0 of 21 (0%)	Not reported
AC-150B 0.005%	0 of 20 (0%)	0 of 20 (0%)	Not reported
Vehicle	0 of 21 (0%)	0 of 21 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Gail L Torkildsen, MD principal investigator

Andover Eye Associates

Nicholas P Marsico, MD principal investigator

East West Eye Institute

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AC-150 Combo, AC-150A 0.1% and AC-150B 0.005% 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 14 Sep 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. 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 14 Sep 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 Onset of Action (15 Minutes Post-dose) (time frame: 3, 5, 7 minutes post-CAC). The study lists 6 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 NCT01134328.

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 14 Sep 2017.