Primary Open Angle GlaucomaPhase 1/2NCT01520116
Study of the Safety and Efficacy of ATS907 in Subjects With Primary Open Angle Glaucoma (POAG) and Ocular Hypertension
A Phase 1/2 study testing Stage 1 - ATS907 - Dose 1, Stage 1 - ATS907 - Dose 2 and Stage 1 - ATS907 - Dose 3 in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by Altheos, Inc. at 5 sites in United States.
Trial summary
This randomized dose-ranging study will evaluate the safety, tolerability, and preliminary efficacy (reduction in intraocular pressure) of multiple dose levels of ATS907, vehicle, or latanoprost in subjects with primary open angle glaucoma or ocular hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- Stage 1 - ATS907 - Dose 1, Stage 1 - ATS907 - Dose 2 and Stage 1 - ATS907 - Dose 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2012to Dec 2012
- Phase
- Phase 1/2
- 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
- Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT) in both eyes
- Unmedicated (post-washout) IOP ≥ 23 mm Hg at 2 eligibility visits: 07:00-09:00 hr on Days O and 1 and IOP > 18 mm Hg at 15:00-17:00 on Day 0 (Stage 1)
- Unmedicated (post-washout) IOP criteria after wash out < 32 mm Hg OU at all times points (Stage 1)
- Unmedicated (post-washout) IOP ≥ 24 mm Hg at 2 eligibility visits: 07:00-09:00 hr on Days O and 1 and IOP > 21 mm Hg at 9:00-17:00 on Day 0 (Stage 2)
- Unmedicated (post-washout) IOP criteria after wash out < 36 mm Hg OU at all times points (Stage 2)
- Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200)
- Must be willing to discontinue the use of all ocular hypotensive medications in both eyes prior to and during the entire course of the study
Who cannot join
- Ophthalmic (in either eye)
- Glaucoma: pseudoexfoliation, steroid induced, pigment dispersion glaucoma, and or history of angle closure. Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s). Prior laser glaucoma surgery is permitted in the non study eye
- Refractive surgery in study eye (e.g., radial keratotomy, PRK, LASIK, etc.)
- Cataract surgery and or other intraocular surgery within three months prior to Screening in either eye.
- History within 3 months prior to Screening of clinically significant moderate or severe chronic or active ocular infection, inflammation, blepharitis, dermatitis, uveitis or conjunctivitis.
- Clinically significant corneal dystrophy, epithelial and or endothelial disease, corneal irregularities and or scarring such that reliable applanation tonometry would prevented.
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- Contact lens wear during the duration of the study.
- Clinically significant ocular disease (e.g. diabetic retinopathy, macular degeneration, or uveitis) which might interfere or progress during the study.
- Central corneal thickness < 480 or > 600 μm in the study eye
- Systemic
- Clinically significant abnormalities in laboratory tests at screening.
- Clinically significant systemic disease (e.g., uncontrolled diabetes, uncontrolled hyper or hypotension, hepatic, renal, endocrine or cardiovascular disorders). Participation in any investigational study within the past 30 days.
- Changes of systemic medication that could have a substantial effect on IOP and or systemic blood pressure within 7 days prior to Baseline (Day 0).
- Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. An adult woman is considered to be of childbearing potential unless she is one year post-menopausal or three months post-surgical sterilization. All females of childbearing potential must have a negative urine pregnancy test result at the Screening visit and a negative urine and serum pregnancy at Baseline (Day 0) and must not intend to become pregnant during the study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Artesia, California
Study site
Cleveland, Ohio
Study site
Glendale, California
Study site
Saint Joseph, Michigan
Study site
San Antonio, Texas
About this study
Official title: A Phase 1/2a Randomized, Investigator-masked, Placebo- and Active-controlled, Dose-ranging Study of the Safety and Efficacy of ATS907 in Subjects With Primary Open Angle Glaucoma (POAG) and Ocular Hypertension
This randomized dose-ranging study will evaluate the safety, tolerability, and preliminary efficacy (reduction in intraocular pressure) of multiple dose levels of ATS907, vehicle, or latanoprost in subjects with primary open angle glaucoma or ocular hypertension. In the first portion, approximately 75 subjects will be randomized to receive either ATS907 or vehicle eye drops for up to 28 days, administered both once and twice daily. In the second portion, up to 180 subjects will be randomized to receive either ATS907 or latanoprost for up to 28 days. Plasma pharmacokinetics will also be evaluated during the first portion of the study.
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Being tested
- Stage 1 - ATS907 - Dose 1, Stage 1 - ATS907 - Dose 2, Stage 1 - ATS907 - Dose 3, Stage 1 - ATS907 - Dose 4, Stage 1 - Vehicle
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stage 1 - ATS907 - Dose 1Drug
QD and/or BID dosing for 28 days
Stage 1 - ATS907 - Dose 2Drug
QD and/or BID dosing for 28 days
Stage 1 - ATS907 - Dose 3Drug
QD and/or BID dosing for 28 days
Stage 1 - ATS907 - Dose 4Drug
QD and/or BID dosing for 28 days
Stage 1 - VehicleDrug
QD and/or BID dosing for 28 days
Stage 2 - ATS907 - Dose A - to be selected based on Stage 1Drug
QD and/or BID dosing for 4 days
Stage 2 - ATS907 - Dose B - to be selected based on Stage 1Drug
QD and/or BID dosing for 4 days
TimopticDrug
0.5%
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 - Arm 1 - Dose 1 | Experimental | Not described Receives: Drug: Stage 1 - ATS907 - Dose 1 |
| Stage 1 - Arm 2 - Dose 2 | Experimental | Not described Receives: Drug: Stage 1 - ATS907 - Dose 2 |
| Stage 1 - Arm 3 - Dose 3 | Experimental | Not described Receives: Drug: Stage 1 - ATS907 - Dose 3 |
| Stage 1 - Arm 4 - Dose 4 | Experimental | Not described Receives: Drug: Stage 1 - ATS907 - Dose 4 |
| Stage 1 - Arm 5 - Vehicle | Placebo comparator | Not described Receives: Drug: Stage 1 - Vehicle |
| Stage 2 - Arm 1 - Dose A - to be selected based on Stage 1 | Experimental | Not described Receives: Drug: Stage 2 - ATS907 - Dose A - to be selected based on Stage 1 |
| Stage 2 - Arm 2 - Dose B - to be selected based on Stage 1 | Experimental | Not described Receives: Drug: Stage 2 - ATS907 - Dose B - to be selected based on Stage 1 |
| Stage 2 - Arm 3 -Timoptic 0.5% BID | Active comparator | Not described Receives: Drug: Timoptic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Intraocular Pressure from Baseline
Measured: Stage 1: Days 14, 21 and 28; Stage 2: Day 4
Secondary outcomes (2)
Observed Intraocular Pressure and % change from Baseline IOP
Measured: Stage 1: Days 0, 1, 4, 14, 21, 28; Stage 2: Days 0, 4
Mean observed, mean change from Baseline and mean % change from Baseline for the mean diurnal IOP
Measured: Stage 1: Days 0, 1, 4, 14, 21, 28; Stage 2: Days 0, 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Altheos, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara Wirostko, MD, Study chair, Altheos, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520116
- Sponsor's protocol ID
- ATS907-201
- Status last verified
- Oct 2012
- First submitted
- 25 Jan 2012
- Last updated
- 1 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a Randomized, Investigator-masked, Placebo- and Active-controlled, Dose-ranging Study of the Safety and Efficacy of ATS907 in Subjects With Primary Open Angle Glaucoma (POAG) and Ocular Hypertension
- ClinicalTrials.gov ID
- NCT01520116
- Acronym / sponsor ID
- ATS907-201
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Altheos, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (estimated)
- First posted
- 27 Jan 2012 (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 randomized dose-ranging study will evaluate the safety, tolerability, and preliminary efficacy (reduction in intraocular pressure) of multiple dose levels of ATS907, vehicle, or latanoprost in subjects with primary open angle glaucoma or ocular hypertension. In the first portion, approximately 75 subjects will be randomized to receive either ATS907 or vehicle eye drops for up to 28 days, administered both once and twice daily. In the second portion, up to 180 subjects will be randomized to receive either ATS907 or latanoprost for up to 28 days. Plasma pharmacokinetics will also be evaluated during the first portion of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Stage 1 - Arm 1 - Dose 1 | Experimental | Drug: Stage 1 - ATS907 - Dose 1 |
| Stage 1 - Arm 2 - Dose 2 | Experimental | Drug: Stage 1 - ATS907 - Dose 2 |
| Stage 1 - Arm 3 - Dose 3 | Experimental | Drug: Stage 1 - ATS907 - Dose 3 |
| Stage 1 - Arm 4 - Dose 4 | Experimental | Drug: Stage 1 - ATS907 - Dose 4 |
| Stage 1 - Arm 5 - Vehicle | Placebo comparator | Drug: Stage 1 - Vehicle |
| Stage 2 - Arm 1 - Dose A - to be selected based on Stage 1 | Experimental | Drug: Stage 2 - ATS907 - Dose A - to be selected based on Stage 1 |
| Stage 2 - Arm 2 - Dose B - to be selected based on Stage 1 | Experimental | Drug: Stage 2 - ATS907 - Dose B - to be selected based on Stage 1 |
| Stage 2 - Arm 3 -Timoptic 0.5% BID | Active comparator | Drug: Timoptic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age or greater
- Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT) in both eyes
- Unmedicated (post-washout) IOP ≥ 23 mm Hg at 2 eligibility visits: 07:00-09:00 hr on Days O and 1 and IOP > 18 mm Hg at 15:00-17:00 on Day 0 (Stage 1)
- Unmedicated (post-washout) IOP criteria after wash out < 32 mm Hg OU at all times points (Stage 1)
- Unmedicated (post-washout) IOP ≥ 24 mm Hg at 2 eligibility visits: 07:00-09:00 hr on Days O and 1 and IOP > 21 mm Hg at 9:00-17:00 on Day 0 (Stage 2)
Key exclusion criteria (14 listed)
- Ophthalmic (in either eye)
- Systemic
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 |
|---|---|---|
| Stage 1 - ATS907 - Dose 1QD and/or BID dosing for 28 days | Drug | Stage 1 - Arm 1 - Dose 1 |
| Stage 1 - ATS907 - Dose 2QD and/or BID dosing for 28 days | Drug | Stage 1 - Arm 2 - Dose 2 |
| Stage 1 - ATS907 - Dose 3QD and/or BID dosing for 28 days | Drug | Stage 1 - Arm 3 - Dose 3 |
| Stage 1 - ATS907 - Dose 4QD and/or BID dosing for 28 days | Drug | Stage 1 - Arm 4 - Dose 4 |
| Stage 1 - VehicleQD and/or BID dosing for 28 days | Drug | Stage 1 - Arm 5 - Vehicle |
| Stage 2 - ATS907 - Dose A - to be selected based on Stage 1QD and/or BID dosing for 4 days | Drug | Stage 2 - Arm 1 - Dose A - to be selected based on Stage 1 |
| Stage 2 - ATS907 - Dose B - to be selected based on Stage 1QD and/or BID dosing for 4 days | Drug | Stage 2 - Arm 2 - Dose B - to be selected based on Stage 1 |
| Timoptic0.5% | Drug | Stage 2 - Arm 3 -Timoptic 0.5% BID |
Primary outcome
Mean Change in Intraocular Pressure from Baseline
Time frame: Stage 1: Days 14, 21 and 28; Stage 2: Day 4
2 secondary outcomes
Observed Intraocular Pressure and % change from Baseline IOP
Time frame: Stage 1: Days 0, 1, 4, 14, 21, 28; Stage 2: Days 0, 4
Mean observed, mean change from Baseline and mean % change from Baseline for the mean diurnal IOP
Time frame: Stage 1: Days 0, 1, 4, 14, 21, 28; Stage 2: Days 0, 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2012.
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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.
Barbara Wirostko, MD study chair
Altheos, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Stage 1 - ATS907 - Dose 1, Stage 1 - ATS907 - Dose 2 and Stage 1 - ATS907 - Dose 3 in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by Altheos, Inc. at 5 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 8 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 1 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. 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 combined 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.
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?
Results are not available in the source record.
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?
Mean Change in Intraocular Pressure from Baseline (time frame: Stage 1: Days 14, 21 and 28; Stage 2: Day 4). 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 1 Nov 2012.