PresbyopiaPhase 3VISION-1NCT04657172
Safety & Efficacy of Pilocarpine Eye Solutions for Temporary Improvement of Near Vision in Presbyopic Adults
A Phase 3 study testing Pilocarpine Ophthalmic in people with Presbyopia, run by Eyenovia Inc. at 9 sites in United States.
Trial summary
Volunteer participants are evaluated for eligibility during a Screening Visit; those meeting study inclusion/exclusion criteria are scheduled for 3 treatment visits. At each treatment visit, 1 of the 3 study solutions is self-administered to both eyes. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbyopia
- What is being tested?
- Pilocarpine Ophthalmic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 9 sitesUnited States
- Study dates
- 15 Dec 2020to 26 Mar 2021
- Phase
- Phase 3
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Primary Inclusion Criteria:
- Poor near vision impacting daily living that requires near correction
- Best-corrected distance visual acuity (BCDVA) of 0.0 logMar or better
- Manifest refraction spherical equivalent ≥ -2.00 Diopters (D) and ≤ +2.00 D
- Monocular DCNVA between 0.4 and 0.7 logMAR, inclusive
Primary Exclusion Criteria:
- Diagnosis of glaucoma or ocular hypertension
- Narrow iridocorneal angles
- History of intraocular surgery, refractive surgery, laser treatment, or iris surgery
- Clinically significant abnormality of cornea, lens, retina, ciliary body, or iris
- Presence/history of a severe/serious ocular condition or any other unstable medical condition
- Presence or history of manifest strabismus, amblyopia, or nystagmus
- Current active eye disease for which topical or systemic ophthalmic medication is necessary, except for dry eye syndrome managed using artificial tears
- Clinically significant external ocular inflammation within 30 days of Screening Visit
- Current use or history of rigid gas permeable (RGP) contact lens use within 30 days of Screening Visit
- Known pilocarpine allergy or contraindication to use of pilocarpine
- Presence or history of congenital heart anomaly, valve disease, or other cardiac disease
- Disabling arthritis or limited motor coordination that would limit the subject's ability to self-administer study solution using the Optejet
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
VISION-1 Study Site #21
Azusa, California, 91702
VISION-1 Study Site #51
Cranberry Township, Pennsylvania, 16066
VISION-1 Study Site #54
Fort Collins, Colorado, 80528
VISION-1 Study Site #17
High Point, North Carolina, 27262
VISION-1 Study Site #50
New York, New York, 10036
VISION-1 Study Site #52
Newport Beach, California, 92663
VISION-1 Study Site #53
Orlando, Florida, 32803
VISION-1 Study Site #22
Raleigh, North Carolina, 27603
VISION-1 Study Site #03
San Antonio, Texas, 78229
About this study
Official title: A Phase 3 Study of the Safety and Efficacy of 1% and 2% Pilocarpine Ophthalmic Solutions Administered With the Optejet® Microdose Dispenser for Temporary Improvement of Near Vision in Adults With Presbyopia
Volunteer participants are evaluated for eligibility during a Screening Visit; those meeting study inclusion/exclusion criteria are scheduled for 3 treatment visits. At each treatment visit, 1 of the 3 study solutions is self-administered to both eyes. Afterwards, efficacy and safety assessments are performed over a 3-hour period.
- Conditions
- Presbyopia
- Being tested
- Pilocarpine Ophthalmic, Placebo
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilocarpine OphthalmicDrug
Also called MicroLine
Pilocarpine 1% or 2% ophthalmic solution administered with the Optejet microdose dispenser
PlaceboDrug
Vehicle ophthalmic solution administered with the Optejet microdose dispenser
| Study group | Role | What they receive |
|---|---|---|
| Pilocarpine 1% Solution | Experimental | 1% pilocarpine ophthalmic solution administered with the Optejet dispenser Receives: Drug: Pilocarpine Ophthalmic |
| Pilocarpine 2% Solution | Experimental | 2% pilocarpine ophthalmic solution administered with the Optejet dispenser Receives: Drug: Pilocarpine Ophthalmic |
| Placebo Solution | Placebo comparator | Placebo ophthalmic solution administered with the Optejet dispenser Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular distance corrected near visual acuity (DCNVA)
The proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular DCNVA as compared to baseline.
Measured: 120 minutes post-dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start15 Dec 2020
- Primary completion26 Mar 2021
- Study completion26 Mar 2021
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eyenovia Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tsontcho (Sean) Ianchulev, MD, MPH, Study chair, Eyenovia Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657172
- Sponsor's protocol ID
- EYN-PRS-PI-31
- Acronym
- VISION-1
- Status last verified
- Aug 2021
- First submitted
- 1 Dec 2020
- Last updated
- 9 Aug 2021
- 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 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Study of the Safety and Efficacy of 1% and 2% Pilocarpine Ophthalmic Solutions Administered With the Optejet® Microdose Dispenser for Temporary Improvement of Near Vision in Adults With Presbyopia
- ClinicalTrials.gov ID
- NCT04657172
- Acronym / sponsor ID
- VISION-1 / EYN-PRS-PI-31
- Conditions
- Presbyopia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Eyenovia Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 26 Mar 2021 (actual)
- Study completion
- 26 Mar 2021 (actual)
- First posted
- 8 Dec 2020 (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.
Volunteer participants are evaluated for eligibility during a Screening Visit; those meeting study inclusion/exclusion criteria are scheduled for 3 treatment visits. At each treatment visit, 1 of the 3 study solutions is self-administered to both eyes. Afterwards, efficacy and safety assessments are performed over a 3-hour period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pilocarpine 1% Solution | Experimental | Drug: Pilocarpine Ophthalmic1% pilocarpine ophthalmic solution administered with the Optejet dispenser |
| Pilocarpine 2% Solution | Experimental | Drug: Pilocarpine Ophthalmic2% pilocarpine ophthalmic solution administered with the Optejet dispenser |
| Placebo Solution | Placebo comparator | Drug: PlaceboPlacebo ophthalmic solution administered with the Optejet dispenser |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Pilocarpine OphthalmicAlso: MicroLinePilocarpine 1% or 2% ophthalmic solution administered with the Optejet microdose dispenser | Drug | Pilocarpine 1% Solution, Pilocarpine 2% Solution |
| PlaceboVehicle ophthalmic solution administered with the Optejet microdose dispenser | Drug | Placebo Solution |
Primary outcome
Proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular distance corrected near visual acuity (DCNVA)
Time frame: 120 minutes post-dosing
The proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular DCNVA as compared to baseline.
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 9 Aug 2021.
- 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.
Tsontcho (Sean) Ianchulev, MD, MPH study chair
Eyenovia Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pilocarpine Ophthalmic in people with Presbyopia, run by Eyenovia Inc. at 9 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?
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 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular distance corrected near visual acuity (DCNVA) (time frame: 120 minutes post-dosing). 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 Aug 2021.