GlaucomaPhase 2NCT00523250
Ocular Hypotensive Efficacy of AR-102
A Phase 2 study testing AR-102 0.003% Ophthalmic Solution, AR-102 0.005% Ophthalmic Solution and AR-102 0.01% Ophthalmic Solution in people with Glaucoma, run by Aerie Pharmaceuticals at 8 sites in United States.
Trial summary
A double-masked, randomized, vehicle-controlled, dose-response study assessing the safety and ocular hypotensive efficacy of AR-102 in subjects with elevated intraocular pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- AR-102 0.003% Ophthalmic Solution, AR-102 0.005% Ophthalmic Solution and AR-102 0.01% Ophthalmic Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 8 sitesUnited States
- Study dates
- Sep 2007to Mar 2008
- Phase
- Phase 2
- 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
- 18 years of age or greater (male, or female not of childbearing potential).
- Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT) in the study eye(s).
- Corrected visual acuity by ETDRS in each eye of +1.0 logMAR units or better
Who cannot join
- Known hypersensitivity to any component of the formulation or to topical anesthetics
- Previous glaucoma intraocular surgery or laser procedures in study eye(s)
- Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, cardiovascular or endocrine disorders) which might interfere with the study.
- Participation in any study involving an investigational drug within the past 30 days.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Texan Eye
Austin, Texas, 78731
Hernando Eye Institute
Brooksville, Florida, 34613
Mundorf Practice
Charlotte, North Carolina, 28204
Taustine Eye Center
Louisville, Kentucky, 40217
Soilsh Practice
Pasadena, California, 91105
Bacharach practice
Petaluma, California, 94954
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
About this study
Official title: A Phase II, First-in-human Dose-escalation, Double-masked, Randomized, Vehicle-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-102 in Subjects With Elevated Intraocular Pressure
A double-masked, randomized, vehicle-controlled, dose-response study assessing the safety and ocular hypotensive efficacy of AR-102 in subjects with elevated intraocular pressure. The Null hypothesis is that the ocular hypotensive efficacy of each dose of AR-102 Ophthalmic Solution will not be different from that of its vehicle.
Read the detailed description
A double-masked, randomized, vehicle-controlled, dose-response study assessing the safety and ocular hypotensive efficacy of AR-102 in subjects with elevated intraocular pressure.
- Conditions
- Glaucoma
- Being tested
- AR-102 0.003% Ophthalmic Solution, AR-102 0.005% Ophthalmic Solution, AR-102 0.01% Ophthalmic Solution, AR-102 0.03% Ophthalmic Solution, AR-102 Vehicle Ophthalmic Solution
- Keywords
- Glaucoma
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR-102 0.003% Ophthalmic SolutionDrug
AR-102 0.005% Ophthalmic SolutionDrug
AR-102 0.01% Ophthalmic SolutionDrug
AR-102 0.03% Ophthalmic SolutionDrug
AR-102 Vehicle Ophthalmic SolutionDrug
| Study group | Role | What they receive |
|---|---|---|
| AR-102 0.003% Ophthalmic Solution | Experimental | q.d. ocular Receives: Drug: AR-102 0.003% Ophthalmic Solution |
| AR-102 0.005% Ophthalmic Solution | Experimental | q.d. ocular Receives: Drug: AR-102 0.005% Ophthalmic Solution |
| AR-102 0.01% Ophthalmic Solution | Experimental | q.d. ocular Receives: Drug: AR-102 0.01% Ophthalmic Solution |
| AR-102 0.03% Ophthalmic Solution | Experimental | q.d. ocular Receives: Drug: AR-102 0.03% Ophthalmic Solution |
| AR-102 Vehicle Ophthalmic Solution | Experimental | q.d. ocular Receives: Drug: AR-102 Vehicle Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint will be mean change from baseline in intraocular pressure at each time point.
Measured: One week
Secondary outcomes (1)
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 questionnaires
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2007 (estimated)
- Study startSep 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerie Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Van Haarlem, MD, Study director, Aerie Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523250
- Sponsor's protocol ID
- AR102-CS201
- Status last verified
- Apr 2014
- First submitted
- 30 Aug 2007
- Last updated
- 8 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, First-in-human Dose-escalation, Double-masked, Randomized, Vehicle-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-102 in Subjects With Elevated Intraocular Pressure
- ClinicalTrials.gov ID
- NCT00523250
- Acronym / sponsor ID
- AR102-CS201
- Conditions
- Glaucoma
- Keywords
- Glaucoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Aerie PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 31 Aug 2007 (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.
A double-masked, randomized, vehicle-controlled, dose-response study assessing the safety and ocular hypotensive efficacy of AR-102 in subjects with elevated intraocular pressure. The Null hypothesis is that the ocular hypotensive efficacy of each dose of AR-102 Ophthalmic Solution will not be different from that of its vehicle.
Detailed description
A double-masked, randomized, vehicle-controlled, dose-response study assessing the safety and ocular hypotensive efficacy of AR-102 in subjects with elevated intraocular pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| AR-102 0.003% Ophthalmic Solution | Experimental | Drug: AR-102 0.003% Ophthalmic Solutionq.d. ocular |
| AR-102 0.005% Ophthalmic Solution | Experimental | Drug: AR-102 0.005% Ophthalmic Solutionq.d. ocular |
| AR-102 0.01% Ophthalmic Solution | Experimental | Drug: AR-102 0.01% Ophthalmic Solutionq.d. ocular |
| AR-102 0.03% Ophthalmic Solution | Experimental | Drug: AR-102 0.03% Ophthalmic Solutionq.d. ocular |
| AR-102 Vehicle Ophthalmic Solution | Experimental | Drug: AR-102 Vehicle Ophthalmic Solutionq.d. ocular |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or greater (male, or female not of childbearing potential).
- Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT) in the study eye(s).
- Corrected visual acuity by ETDRS in each eye of +1.0 logMAR units or better
Key exclusion criteria (4 listed)
- Known hypersensitivity to any component of the formulation or to topical anesthetics
- Previous glaucoma intraocular surgery or laser procedures in study eye(s)
- Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, cardiovascular or endocrine disorders) which might interfere with the study.
- Participation in any study involving an investigational drug within the past 30 days.
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-102 0.003% Ophthalmic Solution | Drug | AR-102 0.003% Ophthalmic Solution |
| AR-102 0.005% Ophthalmic Solution | Drug | AR-102 0.005% Ophthalmic Solution |
| AR-102 0.01% Ophthalmic Solution | Drug | AR-102 0.01% Ophthalmic Solution |
| AR-102 0.03% Ophthalmic Solution | Drug | AR-102 0.03% Ophthalmic Solution |
| AR-102 Vehicle Ophthalmic Solution | Drug | AR-102 Vehicle Ophthalmic Solution |
Primary outcome
The primary efficacy endpoint will be mean change from baseline in intraocular pressure at each time point.
Time frame: One week
1 secondary outcome
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 questionnaires
Time frame: One week
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 8 May 2014.
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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.
Thomas Van Haarlem, MD study director
Aerie Pharmaceuticals, Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AR-102 0.003% Ophthalmic Solution, AR-102 0.005% Ophthalmic Solution and AR-102 0.01% Ophthalmic Solution in people with Glaucoma, run by Aerie Pharmaceuticals at 8 sites 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 3 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 8 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
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?
The primary efficacy endpoint will be mean change from baseline in intraocular pressure at each time point. (time frame: One week). 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 8 May 2014.