Normal Ocular HealthPhase 1NCT01495338
A Comparison of the Safety and Comfort of AC-170
A Phase 1 study testing AC-170 0.17%, AC-170 0.24% (Formulation 1) and AC-170 0.24% (Formulation 2) in people with Normal Ocular Health, run by Aciex Therapeutics, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and comfort of AC-170 compared to a placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Normal Ocular Health
- What is being tested?
- AC-170 0.17%, AC-170 0.24% (Formulation 1) and AC-170 0.24% (Formulation 2)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Dec 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Able and willing to avoid the use of ocular medications or topical ocular preparations within protocol specific time period.
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 the study enrollment or during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Andover Eye Associates
Andover, Massachusetts, 01810
About this study
The purpose of this study is to evaluate the safety and comfort of AC-170 compared to a placebo.
- Conditions
- Normal Ocular Health
- Being tested
- AC-170 0.17%, AC-170 0.24% (Formulation 1), AC-170 0.24% (Formulation 2), Olopatadine hydrochloride 0.2%/Tears Naturale II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AC-170 0.17%Drug
1 drop in one eye at one timepoint
AC-170 0.24% (Formulation 1)Drug
1 drop in one eye at one timepoint
AC-170 0.24% (Formulation 2)Drug
1 drop in one eye at one timepoint
Olopatadine hydrochloride 0.2%/Tears Naturale IIDrug
1 drop in one eye at one timepoint
| Study group | Role | What they receive |
|---|---|---|
| AC-170 0.17% | Experimental | Not described Receives: Drug: AC-170 0.17% |
| AC-170 0.24% (Formulation 1) | Experimental | Not described Receives: Drug: AC-170 0.24% (Formulation 1) |
| AC-170 0.24% (Formulation 2) | Experimental | Not described Receives: Drug: AC-170 0.24% (Formulation 2) |
| Olopatadine hydrochloride 0.2%/Tears Naturale II | Placebo comparator | Not described Receives: Drug: Olopatadine hydrochloride 0.2%/Tears Naturale II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drop Comfort Score
drop comfort on 0-10 scale
Measured: during 3 minute period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Ocular HealthStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aciex Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01495338
- Sponsor's protocol ID
- 11-100-0013
- Status last verified
- Sep 2017
- First submitted
- 15 Dec 2011
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
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 Comparison of the Safety and Comfort of AC-170
- ClinicalTrials.gov ID
- NCT01495338
- Acronym / sponsor ID
- 11-100-0013
- Conditions
- Normal Ocular Health
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aciex Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 20 Dec 2011 (estimated)
- Results
- Not posted in the source record
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 safety and comfort of AC-170 compared to a placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AC-170 0.17% | Experimental | Drug: AC-170 0.17% |
| AC-170 0.24% (Formulation 1) | Experimental | Drug: AC-170 0.24% (Formulation 1) |
| AC-170 0.24% (Formulation 2) | Experimental | Drug: AC-170 0.24% (Formulation 2) |
| Olopatadine hydrochloride 0.2%/Tears Naturale II | Placebo comparator | Drug: Olopatadine hydrochloride 0.2%/Tears Naturale II |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Able and willing to avoid the use of ocular medications or topical ocular preparations within protocol specific time period.
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 the 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-170 0.17%1 drop in one eye at one timepoint | Drug | AC-170 0.17% |
| AC-170 0.24% (Formulation 1)1 drop in one eye at one timepoint | Drug | AC-170 0.24% (Formulation 1) |
| AC-170 0.24% (Formulation 2)1 drop in one eye at one timepoint | Drug | AC-170 0.24% (Formulation 2) |
| Olopatadine hydrochloride 0.2%/Tears Naturale II1 drop in one eye at one timepoint | Drug | Olopatadine hydrochloride 0.2%/Tears Naturale II |
Primary outcome
Drop Comfort Score
Time frame: during 3 minute period
drop comfort on 0-10 scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AC-170 0.17%, AC-170 0.24% (Formulation 1) and AC-170 0.24% (Formulation 2) in people with Normal Ocular Health, 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Drop Comfort Score (time frame: during 3 minute period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.