CompletedNCT02756624Updated Sep 11, 2017Results posted

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

A Phase 3 interventional study of AC-170 0.24% and AC-170 Vehicle in Healthy Subjects, sponsored by Nicox Ophthalmics, Inc.. Completed at 1 site in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2017-09-11.

Sponsored by Nicox Ophthalmics, Inc. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 516
Allocation: Randomized
Ages: 2 Years and older
Sex: All

Study summary

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 studied

Healthy Subjects

In context

Lead sponsor

Nicox Ophthalmics, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 2 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

known 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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication: A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 516 participants (actual)

Study arms

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

Interventions

DrugAC-170 0.24%
DrugAC-170 Vehicle

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
Number of Treatment Related Adverse Events
Adverse events will be measured through study completion
Time frame: up to 12 weeks

Results

Posted Jul 26, 2017

Participant flow

Subjects were recruited from six sites in the US.

Participant flow — Overall Study
Milestone	AC-170 0.24%	AC-170 Vehicle
Started	343	173
Completed	327	166
Not completed	16	7

Outcome measures

PrimaryTolerability 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.

Time frame:: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
Reported as:: Mean · units on a scale

Tolerability of AC 170 0.24% at Visit 1 (Day 1)
units on a scale	AC-170 0.24%	AC-170 Vehicle
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

PrimaryTolerability of AC 170 0.24% at Visit 2 (Day 8)

Time frame:: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
Reported as:: Mean · units on a scale

Tolerability of AC 170 0.24% at Visit 2 (Day 8)
units on a scale	AC-170 0.24%	AC-170 Vehicle
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

PrimaryTolerability of AC 170 0.24% at Visit 3 (Day 22)

Time frame:: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
Reported as:: Mean · units on a scale

Tolerability of AC 170 0.24% at Visit 3 (Day 22)
units on a scale	AC-170 0.24%	AC-170 Vehicle
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

PrimaryNumber of Treatment Related Adverse Events

Adverse events will be measured through study completion

Time frame:: up to 12 weeks
Reported as:: Number · adverse events

Number of Treatment Related Adverse Events
adverse events	AC-170 0.24%	AC-170 Vehicle
Number of Treatment Related Adverse Events	27	15

Adverse events

Collected over Adverse events were collected for the duration of the study. All subjects who received study medication were evaluable for the safety analysis.. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
AC-170 0.24%	—	2/343 (0.6%)	25/343 (7.3%)
AC-170 Vehicle	—	0/173 (0%)	15/173 (8.7%)

Most frequent serious events

Most frequent serious events
Event	AC-170 0.24%	AC-170 Vehicle
Substance abusePsychiatric disorders	1/343	0/173
Gastroesophageal reflux diseaseGastrointestinal disorders	1/343	0/173

Most frequent other events

Most frequent other events
Event	AC-170 0.24%	AC-170 Vehicle
Visual acuity reducedEye disorders	4/343	4/173
Instillation site painGeneral disorders	6/343	1/173
Conjunctival hyperemiaEye disorders	4/343	3/173
Punctate keratitisEye disorders	3/343	3/173
Instillation site erythemaGeneral disorders	0/343	2/173
Pharyngitis streptococcalInfections and infestations	2/343	0/173
Oropharyngeal painRespiratory, thoracic and mediastinal disorders	2/343	0/173
HeadacheNervous system disorders	2/343	0/173
SinusitisInfections and infestations	1/343	1/173
MigraineNervous system disorders	1/343	1/173

Baseline characteristics

Age, Continuous
Age, Continuous(years)	AC-170 0.24%	AC-170 Vehicle	Total
Mean	32.5 ± 16.81	31.8 ± 18.3	32.2 ± 17.31

Age, Customized
Age, Customized(participants)	AC-170 0.24%	AC-170 Vehicle	Total
2-6 years old	18	12	31
2 years old	6	8	14
3 years old	5	2	7
7-12 years old	29	15	44
4-12 years old	36	17	53
13-17 years old	37	17	54
>/= 18 years old	259	129	388

Sex: Female, Male
Sex: Female, Male(Participants)	AC-170 0.24%	AC-170 Vehicle	Total
Female	197	102	299
Male	146	71	217

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	AC-170 0.24%	AC-170 Vehicle	Total
Hispanic or Latino	58	40	98
Not Hispanic or Latino	285	133	418
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	AC-170 0.24%	AC-170 Vehicle	Total
American Indian or Alaska Native	0	1	1
Asian	7	4	11
Native Hawaiian or Other Pacific Islander	2	1	3
Black or African American	53	32	85
White	270	126	396
More than one race	4	0	4
Unknown or Not Reported	7	9	16

Region of Enrollment
Region of Enrollment(participants)	AC-170 0.24%	AC-170 Vehicle	Total
United States	343	173	516

Study locations

1 site

Ora Clinical Site Network
Andover, Massachusetts 01810, United States

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2016, a primary completion of Aug 2016 and a completion of Aug 2016. It does not say whether these dates are actual or estimated.

Results were first posted in Jul 2017, 11 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Apr 20, 2016
First posted: Apr 29, 2016
Start: Apr 2016
Primary completionActual: Aug 2016
CompletionActual: Aug 2016
Results first posted: Jul 26, 2017
Last update: Sep 11, 2017

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Sep 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02756624
Lead sponsor: Nicox Ophthalmics, Inc.
Collaborators: ORA, Inc.
Responsible party: Sponsor
First posted: Apr 29, 2016
Start date: Apr 2016
Primary completion: Aug 2016
Completion: Aug 2016
Results posted: Jul 26, 2017
Last update: Sep 11, 2017

Study contacts

Eugene Protzko, MD

principal investigator · Sedeinberg Protzko Eye Associates

Ranjan Malhotra, MD

principal investigator · Ophthalmology Associates

Stacey Ackerman, MD

principal investigator · Philadelphia Eye Associates

M. Ali Haider, DO

principal investigator · Haider Eye Care

Robert Rice, MD

principal investigator · R&R Eye Research

Gail Torkildsen, MD

principal investigator · Andover Eye Associates

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Cetirizine

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Nicox Ophthalmics, Inc.

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