Normal VolunteersPhase 1NCT01250197
Formulation Comparison in Normal Volunteers
A Phase 1 study testing AR-12286 in people with Normal Volunteers, run by Aerie Pharmaceuticals at 1 site in United States.
Trial summary
This is a double-masked, single-center, crossover study in which normal volunteers will be randomized to receive one of two formulations of 0.5% AR-12286 Ophthalmic Solution for 8 days. Subjects will undergo a minimum 7-day washout, and then receive the alternate treatment for 8 days. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Normal Volunteers
- What is being tested?
- AR-12286
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Dec 2010
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal volunteers
Who cannot join
- Active ophthalmic or systemic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-masked, Crossover Study Assessing the Ocular and Systemic Safety and Systemic Absorption of Two Formulations of 0.5% AR-12286 Ophthalmic Solution in Normal Volunteers
This is a double-masked, single-center, crossover study in which normal volunteers will be randomized to receive one of two formulations of 0.5% AR-12286 Ophthalmic Solution for 8 days. Subjects will undergo a minimum 7-day washout, and then receive the alternate treatment for 8 days.
Read the detailed description
Not desired.
- Conditions
- Normal Volunteers
- Being tested
- AR-12286
- Keywords
- Normal Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR-12286Drug
Ophthalmic Solution
| Study group | Role | What they receive |
|---|---|---|
| Formulation A | Experimental | AR-12286 Ophthalmic Solution Formulation A Receives: Drug: AR-12286 |
| Formulation B | Experimental | AR-12286 Ophthalmic Solution Formulation B Receives: Drug: AR-12286 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular safety
The primary safety endpoints will be visual acuity, objective biomicroscopic and ophthalmoscopic examination, and subjective comfort as measured by adverse events in response to subject symptom queries.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal VolunteersStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aerie Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tom van Haarlem, MD, Study director, Aerie Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250197
- Sponsor's protocol ID
- AR-12286-CS101
- Status last verified
- Dec 2010
- First submitted
- 29 Nov 2010
- Last updated
- 22 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-masked, Crossover Study Assessing the Ocular and Systemic Safety and Systemic Absorption of Two Formulations of 0.5% AR-12286 Ophthalmic Solution in Normal Volunteers
- ClinicalTrials.gov ID
- NCT01250197
- Acronym / sponsor ID
- AR-12286-CS101
- Conditions
- Normal Volunteers
- Keywords
- Normal Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Aerie PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 30 Nov 2010 (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.
This is a double-masked, single-center, crossover study in which normal volunteers will be randomized to receive one of two formulations of 0.5% AR-12286 Ophthalmic Solution for 8 days. Subjects will undergo a minimum 7-day washout, and then receive the alternate treatment for 8 days.
Detailed description
Not desired.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formulation A | Experimental | Drug: AR-12286AR-12286 Ophthalmic Solution Formulation A |
| Formulation B | Experimental | Drug: AR-12286AR-12286 Ophthalmic Solution Formulation B |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Normal volunteers
Key exclusion criteria (1 listed)
- Active ophthalmic or systemic disease
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 |
|---|---|---|
| AR-12286Ophthalmic Solution | Drug | Formulation A, Formulation B |
Primary outcome
Ocular safety
Time frame: 3 weeks
The primary safety endpoints will be visual acuity, objective biomicroscopic and ophthalmoscopic examination, and subjective comfort as measured by adverse events in response to subject symptom queries.
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 22 Dec 2010.
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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.
Tom van Haarlem, MD study director
Aerie Pharmaceuticals, Inc.
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 AR-12286 in people with Normal Volunteers, run by Aerie Pharmaceuticals 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 1 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 22 Dec 2010. 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 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?
Ocular safety (time frame: 3 weeks). 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 22 Dec 2010.