Healthy SubjectsPhase 3NCT02756624

A Multi-Center, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AC-170 Ophthalmic Solution

A Phase 3 study testing AC-170 0.24% in people with Healthy Subjects, run by Nicox Ophthalmics, 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

This is study is evaluating the safety and tolerability of AC-170 Ophthalmic Solution Read more about this study

Who is it for?: Ages 2 years and older
Conditions the study is for: Healthy Subjects
What is being tested?: AC-170 0.24%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 516 participants
Where: 1 siteUnited States
Study dates: Apr 2016to Aug 2016
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 2 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

at least 2 years of age
be able to self-administer eye drops or have a parent/legal guardian available for this purpose
if less than 18 years old have a history or family history of atopic disease (including allergic conjunctivitis)
have ocular health within normal limits

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 trial parameters
use of disallowed medication during the period indicated prior to the enrollment or during the study
be pregnant, nursing, or planning a pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

Ora Clinical Site Network
Andover, Massachusetts, 01810

Other trials in United States

About this study

Official title: A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AC-170 Ophthalmic Solution

This is study is evaluating the safety and tolerability of AC-170 Ophthalmic Solution

Read the detailed description

Central Cornea Endothelial Cell Counts will be done on a subset of approximately 150 subjects to complete 100 subjects as part of the safety measures.

Conditions: Healthy Subjects
Being tested: AC-170 0.24%, AC-170 Vehicle

What participants receive

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

AC-170 0.24%Drug
AC-170 VehicleDrug

Study groups in NCT02756624
Study group	Role	What they receive
AC-170 0.24%	Experimental	1 drop in each eye 3 times daily for up to 6 weeks Receives: Drug: AC-170 0.24%
AC-170 Vehicle	Placebo comparator	1 drop in each eye 3 times daily for up to 6 weeks Receives: Drug: AC-170 Vehicle

What is being measured

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

Tolerability of AC 170 0.24% at Visit 1 (Day 1)
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, 30 Seconds Post-Instillation, 1 minute Post-Instillation
Tolerability of AC 170 0.24% at Visit 2 (Day 8)
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, 30 Seconds Post-Instillation, 1 minute Post-Instillation
Tolerability of AC 170 0.24% at Visit 3 (Day 22)
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, 30 Seconds Post-Instillation, 1 minute Post-Instillation
Number of Treatment Related Adverse Events
Adverse events will be measured through study completion
Measured: up to 12 weeks

Timeline

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

Apr 2016Aug 2016

First posted29 Apr 2016 (estimated)
Study startApr 2016
Primary completionAug 2016
Study completionAug 2016

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 Healthy SubjectsStudies 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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 516 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02756624
Sponsor's protocol ID: 15-100-0010
Status last verified: Sep 2017
First submitted: 20 Apr 2016
Last updated: 11 Sep 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?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AC-170 Ophthalmic Solution
ClinicalTrials.gov ID: NCT02756624
Acronym / sponsor ID: 15-100-0010
Conditions: Healthy Subjects
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 516 participants (actual)
Lead sponsor: Nicox Ophthalmics, Inc.Industry (pharma, biotech, devices)
Collaborators: ORA, Inc.
Study start: Apr 2016
Primary completion: Aug 2016 (actual)
Study completion: Aug 2016 (actual)
First posted: 29 Apr 2016 (estimated)
Results: Posted 26 Jul 2017

Clinical summary

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

This is study is evaluating the safety and tolerability of AC-170 Ophthalmic Solution

Detailed description

Central Cornea Endothelial Cell Counts will be done on a subset of approximately 150 subjects to complete 100 subjects as part of the safety measures.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
AC-170 0.24%	Experimental	Drug: AC-170 0.24%1 drop in each eye 3 times daily for up to 6 weeks
AC-170 Vehicle	Placebo comparator	Drug: AC-170 Vehicle1 drop in each eye 3 times daily for up to 6 weeks

Who may qualify

Ages: 2 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

at least 2 years of age
be able to self-administer eye drops or have a parent/legal guardian available for this purpose
if less than 18 years old have a history or family history of atopic disease (including allergic conjunctivitis)
have ocular health within normal limits

Key exclusion criteria (4 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 trial parameters
use of disallowed medication during the period indicated prior to the enrollment or during the study
be pregnant, nursing, or planning a pregnancy

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%	Drug	AC-170 0.24%
AC-170 Vehicle	Drug	AC-170 Vehicle

Primary outcome

Tolerability of AC 170 0.24% at Visit 1 (Day 1)
Time frame: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
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.
Tolerability of AC 170 0.24% at Visit 2 (Day 8)
Time frame: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
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.
Tolerability of AC 170 0.24% at Visit 3 (Day 22)
Time frame: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
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.
Number of Treatment Related Adverse Events
Time frame: up to 12 weeks
Adverse events will be measured through study completion

Results and safety

Results posted to the registry on 26 Jul 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%	343	327
AC-170 Vehicle	173	166

Primary outcome: Tolerability of AC 170 0.24% at Visit 1 (Day 1)

Time frame: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation. Mean (Standard Deviation). Unit: units on a scale

Measure	AC-170 0.24% n = 309	AC-170 Vehicle n = 152
Upon instillation	0.87 (1.435)	0.50 (1.106)
30 seconds post-instillation	0.64 (1.181)	0.42 (0.982)
1 minute post-instillation	0.42 (1.001)	0.31 (0.822)

Population analysed: Intent to Treat (ITT)

Primary outcome: Tolerability of AC 170 0.24% at Visit 2 (Day 8)

Time frame: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation. Mean (Standard Deviation). Unit: units on a scale

Measure	AC-170 0.24% n = 299	AC-170 Vehicle n = 149
Upon instillation	0.65 (1.279)	0.19 (0.665)
30 seconds post-instillation	0.38 (0.872)	0.24 (0.766)
1 minute post-instillation	0.26 (0.801)	0.21 (0.650)

Population analysed: Intent to Treat (ITT)

Primary outcome: Tolerability of AC 170 0.24% at Visit 3 (Day 22)

Time frame: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation. Mean (Standard Deviation). Unit: units on a scale

Measure	AC-170 0.24% n = 295	AC-170 Vehicle n = 148
Upon instillation	0.66 (1.321)	0.43 (1.036)
30 seconds post-instillation	0.37 (0.942)	0.25 (0.725)
1 minute post-instillation	0.24 (0.715)	0.14 (0.446)

Population analysed: Intent to Treat (ITT)

Primary outcome: Number of Treatment Related Adverse Events

Time frame: up to 12 weeks. Number. Unit: adverse events

Measure	AC-170 0.24% n = 343	AC-170 Vehicle n = 173
Value	27	15

Population analysed: Intent to Treat (ITT)

Adverse events

Time frame: Adverse events were collected for the duration of the study. 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%	2 of 343 (0.6%)	25 of 343 (7.3%)	Not reported
AC-170 Vehicle	0 of 173 (0%)	15 of 173 (8.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 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.

Eugene Protzko, MD principal investigator

Sedeinberg Protzko Eye Associates

Ranjan Malhotra, MD principal investigator

Ophthalmology 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% in people with Healthy Subjects, run by Nicox Ophthalmics, 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 4 inclusion and 4 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 11 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. 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 26 Jul 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?

Tolerability of AC 170 0.24% at Visit 1 (Day 1) (time frame: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation). 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 NCT02756624.

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 11 Sep 2017.