PresbyopiaPhase 4NCT05624320
Using AGN-190584 in Subjects Utilizing Single -Use Daily, Contact Lenses
A Phase 4 study testing AGN-190584 in people with Presbyopia, run by Gordon Schanzlin New Vision.
Trial summary
AGN-190584 has gone through many clinical trials showing its safety and effectiveness in individuals from 40-55 years of age. There has been no published data on the use of this product in individuals corrected with contact lenses for distance vision. Read more about this study
- Who is it for?
- Ages 40 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbyopia
- What is being tested?
- AGN-190584
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 30 Jun 2023
- Phase
- Phase 4
- 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 40 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects from age 40-55
- Prescription range: -4.00 - +1.00
- Correctable to 20/25 or better for distance
- Adapted single use contact lens patients
- Subjects able to understand the consent agreement and willing to participate
Who cannot join
- Non-contact lens wearer
- Previous use of AGN-190584
- Out of age range
- Out of prescription range
- Any corneal abnormality
- Any eye pathology
- Iritis
- Know allergy to pilocarpine
About this study
Official title: Improved Near Vision and Intermediate Without Loss of Binocular Distance Vision Using AGN-190584 in Subjects Utilizing Single -Use Daily, Contact Lenses for Distance Vision Correction in Both Eyes
AGN-190584 has gone through many clinical trials showing its safety and effectiveness in individuals from 40-55 years of age. There has been no published data on the use of this product in individuals corrected with contact lenses for distance vision. There are many other applications AGN-190584 could be used for and further studies will show the effectiveness for each.
Read the detailed description
The study is a single center open label, single arm study with no control and no randomization. Investigators will enroll 30 presbyopic patients between the ages of 40-55 years old who have undergone successful contact lens fitting in single-use, daily, contact lenses between the spectacle lens powers of -4.00 -to +1.00, in both eyes for best distance correction by the primary investigator. Investigators will measure change in letters read at near and intermediate vision from baseline. Subjects will be required to apply AGN-190584 drops once daily OU. Subjects will be applying the drops on their own every day including the day of visits. During treatment investigators will measure changes in letters read from baseline in intermediate and near vision at the days 7, 14 and 21. These visits will be conducted between 2 and 4 hours after instillation of AGN-190584, with 3 hours being the target time.
- Conditions
- Presbyopia
- Being tested
- AGN-190584
- Keywords
- presbyopia
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGN-190584Drug
miotic for treatment of presbyopia
| Study group | Role | What they receive |
|---|---|---|
| single center open label, single arm study with no control and no randomization | Experimental | Investigators will enroll 30 presbyopic patients between the ages of 40-55 years old who have undergone successful contact lens fitting in single-use, daily, contact lenses between the spectacle lens powers of -4.00 -to +1.00, in both eyes for best distance correction by the primary investigator Receives: Drug: AGN-190584 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be changes from baseline in letters read at near without loss of distance acuity (defined as loss of 5 or more letters)
Measured: 30 days
Secondary outcomes (1)
secondary endpoint will be changes in intermediate letters read from baseline
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start1 Dec 2022 (estimated)
- Primary completion30 May 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Why it stopped: Lack of interest
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gordon Schanzlin New Vision
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624320
- Sponsor's protocol ID
- Gordon Schanzlin New Vision
- Status last verified
- Nov 2022
- First submitted
- 14 Nov 2022
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Near Vision and Intermediate Without Loss of Binocular Distance Vision Using AGN-190584 in Subjects Utilizing Single -Use Daily, Contact Lenses for Distance Vision Correction in Both Eyes
- ClinicalTrials.gov ID
- NCT05624320
- Acronym / sponsor ID
- Gordon Schanzlin New Vision
- Conditions
- Presbyopia
- Keywords
- presbyopia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of interest
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Gordon Schanzlin New VisionUniversity, hospital or other
- Collaborators
- AbbVie
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 22 Nov 2022 (actual)
- 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.
AGN-190584 has gone through many clinical trials showing its safety and effectiveness in individuals from 40-55 years of age. There has been no published data on the use of this product in individuals corrected with contact lenses for distance vision. There are many other applications AGN-190584 could be used for and further studies will show the effectiveness for each.
Detailed description
The study is a single center open label, single arm study with no control and no randomization. Investigators will enroll 30 presbyopic patients between the ages of 40-55 years old who have undergone successful contact lens fitting in single-use, daily, contact lenses between the spectacle lens powers of -4.00 -to +1.00, in both eyes for best distance correction by the primary investigator. Investigators will measure change in letters read at near and intermediate vision from baseline. Subjects will be required to apply AGN-190584 drops once daily OU. Subjects will be applying the drops on their own every day including the day of visits. During treatment investigators will measure changes in letters read from baseline in intermediate and near vision at the days 7, 14 and 21. These visits will be conducted between 2 and 4 hours after instillation of AGN-190584, with 3 hours being the target time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single center open label, single arm study with no control and no randomization | Experimental | Drug: AGN-190584Investigators will enroll 30 presbyopic patients between the ages of 40-55 years old who have undergone successful contact lens fitting in single-use, daily, contact lenses between the spectacle lens powers of -4.00 -to +1.00, in both eyes for best distance correction by the primary investigator |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects from age 40-55
- Prescription range: -4.00 - +1.00
- Correctable to 20/25 or better for distance
- Adapted single use contact lens patients
- Subjects able to understand the consent agreement and willing to participate
Key exclusion criteria (8 listed)
- Non-contact lens wearer
- Previous use of AGN-190584
- Out of age range
- Out of prescription range
- Any corneal abnormality
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-190584miotic for treatment of presbyopia | Drug | single center open label, single arm study with no control and no randomization |
Primary outcome
The primary endpoint will be changes from baseline in letters read at near without loss of distance acuity (defined as loss of 5 or more letters)
Time frame: 30 days
1 secondary outcome
secondary endpoint will be changes in intermediate letters read from baseline
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AGN-190584 in people with Presbyopia, run by Gordon Schanzlin New Vision.
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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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 endpoint will be changes from baseline in letters read at near without loss of distance acuity (defined as loss of 5 or more letters) (time frame: 30 days). 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 9 Apr 2024.