Glaucoma, Open-AnglePhase 1NCT01215786
Safety and Pharmacodynamics Study of AGN-207281 Ophthalmic Solutions Compared With Timolol Ophthalmic Solution or Placebo in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma
A Phase 1 study testing timolol ophthalmic solution 0.5% in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Allergan at 1 site in United States.
Trial summary
This is an exploratory study that will evaluate the safety and pharmacodynamics of up to 3 doses of AGN-207281 based on an ongoing review of data during the study period compared with timolol ophthalmic solution or placebo in patients with ocular hypertension or primary open-angle glaucoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Open-Angle, Ocular Hypertension
- What is being tested?
- timolol ophthalmic solution 0.5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Dec 2010
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Ocular hypertension or primary open-angle glaucoma in each eye
- Requires IOP-lowering therapy in both eyes
- Visual acuity score of 20/100 or better in each eye
Who cannot join
- Experienced significant weight change (over 10 pounds) within 60 days
- History of alcohol or drug addiction
- History of migraines or frequent headaches
- Anticipated wearing of contact lenses during the study
- Required chronic use of ocular medications during study
- Eye surgery within 6 months
Show all 9Show fewer
- Use of systemic beta blockers (eg, atenolol, propranolol) within 2 months
- Use of oral, intramuscular, intravenous corticosteroids within 21 days
- Use of ophthalmic corticosteroids within 2 months
Trial locations and contacts
1 site in 1 country.
About this study
This is an exploratory study that will evaluate the safety and pharmacodynamics of up to 3 doses of AGN-207281 based on an ongoing review of data during the study period compared with timolol ophthalmic solution or placebo in patients with ocular hypertension or primary open-angle glaucoma.
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Being tested
- AGN-207281 ophthalmic solutions (0.1% and 0.3%); AGN-207281 vehicle ophthalmic solution (placebo), timolol ophthalmic solution 0.5%, AGN-207281 vehicle ophthalmic solution (Placebo)
- 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.
AGN-207281 ophthalmic solutions (0.1% and 0.3%); AGN-207281 vehicle ophthalmic solution (placebo)Drug
One drop of AGN-207281 ophthalmic solutions (0.1% on Days 1-7 and 0.3% on Days 8-14) instilled to both eyes in the morning followed by one drop of AGN-207281 vehicle ophthalmic solution (placebo) instilled to both eyes in the evening for 13 days.
timolol ophthalmic solution 0.5%Drug
One drop of timolol ophthalmic solution 0.5% instilled to both eyes, in the morning for 14 days, and in the evening for 13 days
AGN-207281 vehicle ophthalmic solution (Placebo)Drug
One drop of AGN-207281 vehicle ophthalmic solution instilled to both eyes, in the morning for 14 days and in the evening for 13 days.
| Study group | Role | What they receive |
|---|---|---|
| AGN-207281 ophthalmic solution | Other | AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14 Receives: Drug: AGN-207281 ophthalmic solutions (0.1% and 0.3%); AGN-207281 vehicle ophthalmic solution (placebo) |
| Timolol ophthalmic solution 0.5% | Active comparator | timolol ophthalmic solution 0.5% Receives: Drug: timolol ophthalmic solution 0.5% |
| Placebo | Placebo comparator | AGN-207281 vehicle ophthalmic solution (Placebo) Receives: Drug: AGN-207281 vehicle ophthalmic solution (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14
Change from baseline in worse eye IOP at day 14. Worse eye IOP refers to the eye with the worse (highest) baseline IOP (a measurement of the fluid pressure inside the eye). A negative number change from baseline indicates a reduction in IOP (improvement).
Measured: Baseline, Day 14
Secondary outcomes (2)
Mean Concentration of AGN-207281 in Plasma at Day 7
Mean concentration of AGN-207281 in plasma at day 7. Plasma is the liquid component of the blood in which the blood cells are suspended. On day 7, the plasma sample collected 15 minutes post-morning dose from each patient receiving AGN-207281 was analyzed to determine the average drug concentration levels of AGN-207281.
Measured: Day 7
Mean Concentration of AGN-207281 in Plasma at Day 14
Mean concentration of AGN-207281 in plasma at day 14. Plasma is the liquid component of the blood in which the blood cells are suspended. On day 14, the plasma sample collected 15 minutes post-morning dose from each patient receiving AGN-207281 was analyzed to determine the average drug concentration levels of AGN-207281.
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startOct 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.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Glaucoma, Open-AngleStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215786
- Sponsor's protocol ID
- 207281-004
- Status last verified
- Jul 2015
- First submitted
- 5 Oct 2010
- Last updated
- 17 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Pharmacodynamics Study of AGN-207281 Ophthalmic Solutions Compared With Timolol Ophthalmic Solution or Placebo in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma
- ClinicalTrials.gov ID
- NCT01215786
- Acronym / sponsor ID
- 207281-004
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 7 Oct 2010 (estimated)
- Results
- Posted 16 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an exploratory study that will evaluate the safety and pharmacodynamics of up to 3 doses of AGN-207281 based on an ongoing review of data during the study period compared with timolol ophthalmic solution or placebo in patients with ocular hypertension or primary open-angle glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AGN-207281 ophthalmic solution | Other | Drug: AGN-207281 ophthalmic solutions (0.1% and 0.3%); AGN-207281 vehicle ophthalmic solution (placebo)AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14 |
| Timolol ophthalmic solution 0.5% | Active comparator | Drug: timolol ophthalmic solution 0.5%timolol ophthalmic solution 0.5% |
| Placebo | Placebo comparator | Drug: AGN-207281 vehicle ophthalmic solution (Placebo)AGN-207281 vehicle ophthalmic solution (Placebo) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ocular hypertension or primary open-angle glaucoma in each eye
- Requires IOP-lowering therapy in both eyes
- Visual acuity score of 20/100 or better in each eye
Key exclusion criteria (9 listed)
- Experienced significant weight change (over 10 pounds) within 60 days
- History of alcohol or drug addiction
- History of migraines or frequent headaches
- Anticipated wearing of contact lenses during the study
- Required chronic use of ocular medications during 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 |
|---|---|---|
| AGN-207281 ophthalmic solutions (0.1% and 0.3%); AGN-207281 vehicle ophthalmic solution (placebo)One drop of AGN-207281 ophthalmic solutions (0.1% on Days 1-7 and 0.3% on Days 8-14) instilled to both eyes in the morning followed by one drop of AGN-207281 vehicle ophthalmic solution (placebo) instilled to both eyes in the evening for 13 days. | Drug | AGN-207281 ophthalmic solution |
| timolol ophthalmic solution 0.5%One drop of timolol ophthalmic solution 0.5% instilled to both eyes, in the morning for 14 days, and in the evening for 13 days | Drug | Timolol ophthalmic solution 0.5% |
| AGN-207281 vehicle ophthalmic solution (Placebo)One drop of AGN-207281 vehicle ophthalmic solution instilled to both eyes, in the morning for 14 days and in the evening for 13 days. | Drug | Placebo |
Primary outcome
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14
Time frame: Baseline, Day 14
Change from baseline in worse eye IOP at day 14. Worse eye IOP refers to the eye with the worse (highest) baseline IOP (a measurement of the fluid pressure inside the eye). A negative number change from baseline indicates a reduction in IOP (improvement).
2 secondary outcomes
Mean Concentration of AGN-207281 in Plasma at Day 7
Time frame: Day 7
Mean Concentration of AGN-207281 in Plasma at Day 14
Time frame: Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Glaucoma, Open-Angle
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
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.
Medical Director study director
Allergan
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 timolol ophthalmic solution 0.5% in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Allergan 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 3 inclusion and 9 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 17 Aug 2015. 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?
Yes. Results are posted in the registry (first posted 16 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 (time frame: Baseline, Day 14). 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 17 Aug 2015.