PresbyopiaPhase 2NCT02197806
Safety and Efficacy of AGN-199201 and AGN-190584 in Patients With Presbyopia
A Phase 2 study testing AGN-199201 and AGN-190584 in people with Presbyopia, run by Allergan at 1 site in United States.
Trial summary
A study to evaluate the safety and efficacy of AGN-199201 alone, AGN-190584 alone and concurrent use of AGN-199201 and AGN-190584 in patients with presbyopia (inability to focus for near vision). Read more about this study
- Who is it for?
- Ages 40 to 55 years
- Conditions the study is for
- Presbyopia
- What is being tested?
- AGN-199201 and AGN-190584
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Nov 2014
- Phase
- Phase 2
- 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 40 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- -Presbyopia in each eye that impacts daily activities.
Who cannot join
- Use of any topical ophthalmic medications, including artificial tears
- Contact lens use in either eye within 14 days or planned use during the study
- History of eye surgery
- Diagnosis of any type of glaucoma or ocular hypertension
Trial locations and contacts
1 site in 1 country.
About this study
A study to evaluate the safety and efficacy of AGN-199201 alone, AGN-190584 alone and concurrent use of AGN-199201 and AGN-190584 in patients with presbyopia (inability to focus for near vision).
- Conditions
- Presbyopia
- Being tested
- AGN-199201, AGN-190584, AGN-199201 Vehicle
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGN-199201Drug
1 to 2 drops of AGN-199201 ophthalmic solution in the eye(s) as per protocol.
AGN-190584Drug
1 to 2 drops of AGN-190584 ophthalmic solution in the eye(s) as per protocol.
AGN-199201 VehicleDrug
1 to 2 drops of AGN-199201 vehicle in the eye(s) as per protocol.
| Study group | Role | What they receive |
|---|---|---|
| AGN-199201 | Experimental | 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each. Receives: Drug: AGN-199201; Drug: AGN-199201 Vehicle |
| AGN-190584 | Experimental | 1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each. Receives: Drug: AGN-190584; Drug: AGN-199201 Vehicle |
| AGN-199201 + AGN-190584 in One Eye | Experimental | 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each. Receives: Drug: AGN-199201; Drug: AGN-190584; Drug: AGN-199201 Vehicle |
| AGN-199201 + AGN-190584 in Both Eyes | Experimental | 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each. Receives: Drug: AGN-199201; Drug: AGN-190584 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With at Least a 2 Line Improvement From Baseline in Uncorrected Near Visual Acuity (UNVA) in the Non-Dominant Eye
UNVA is assessed without corrective lenses in the non-dominant eye. UNVA is measured using an eye chart and is reported as the number of lines read correctly. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of lines read correctly means that vision has improved. The percentages of patients with at least a 2 or more line improvement in UNVA in the non-dominant eye are presented.
Measured: Baseline, Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2014
- Study completionNov 2014
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 PresbyopiaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 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
- NCT02197806
- Sponsor's protocol ID
- 199201-007
- Status last verified
- Oct 2015
- First submitted
- 21 Jul 2014
- Last updated
- 3 Dec 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 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of AGN-199201 and AGN-190584 in Patients With Presbyopia
- ClinicalTrials.gov ID
- NCT02197806
- Acronym / sponsor ID
- 199201-007
- Conditions
- Presbyopia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 23 Jul 2014 (estimated)
- Results
- Posted 3 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate the safety and efficacy of AGN-199201 alone, AGN-190584 alone and concurrent use of AGN-199201 and AGN-190584 in patients with presbyopia (inability to focus for near vision).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AGN-199201 | Experimental | Drug: AGN-199201, Drug: AGN-199201 Vehicle1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each. |
| AGN-190584 | Experimental | Drug: AGN-190584, Drug: AGN-199201 Vehicle1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each. |
| AGN-199201 + AGN-190584 in One Eye | Experimental | Drug: AGN-199201, Drug: AGN-190584, Drug: AGN-199201 Vehicle1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each. |
| AGN-199201 + AGN-190584 in Both Eyes | Experimental | Drug: AGN-199201, Drug: AGN-1905841 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -Presbyopia in each eye that impacts daily activities.
Key exclusion criteria (4 listed)
- Use of any topical ophthalmic medications, including artificial tears
- Contact lens use in either eye within 14 days or planned use during the study
- History of eye surgery
- Diagnosis of any type of glaucoma or ocular hypertension
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-1992011 to 2 drops of AGN-199201 ophthalmic solution in the eye(s) as per protocol. | Drug | AGN-199201, AGN-199201 + AGN-190584 in Both Eyes, AGN-199201 + AGN-190584 in One Eye |
| AGN-1905841 to 2 drops of AGN-190584 ophthalmic solution in the eye(s) as per protocol. | Drug | AGN-190584, AGN-199201 + AGN-190584 in Both Eyes, AGN-199201 + AGN-190584 in One Eye |
| AGN-199201 Vehicle1 to 2 drops of AGN-199201 vehicle in the eye(s) as per protocol. | Drug | AGN-190584, AGN-199201, AGN-199201 + AGN-190584 in One Eye |
Primary outcome
Percentage of Participants With at Least a 2 Line Improvement From Baseline in Uncorrected Near Visual Acuity (UNVA) in the Non-Dominant Eye
Time frame: Baseline, Day 3
UNVA is assessed without corrective lenses in the non-dominant eye. UNVA is measured using an eye chart and is reported as the number of lines read correctly. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of lines read correctly means that vision has improved. The percentages of patients with at least a 2 or more line improvement in UNVA in the non-dominant eye are presented.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
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 2 study testing AGN-199201 and AGN-190584 in people with Presbyopia, 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 1 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 3 Dec 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. 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?
Yes. Results are posted in the registry (first posted 3 Dec 2015). 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?
Percentage of Participants With at Least a 2 Line Improvement From Baseline in Uncorrected Near Visual Acuity (UNVA) in the Non-Dominant Eye (time frame: Baseline, Day 3). 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 3 Dec 2015.