PresbyopiaPhase 2NCT03201562
A Single-Center, Double-Masked Evaluation of the Efficacy and Safety of PRX-100 in the Treatment of Early to Moderate Presbyopia
A Phase 2 study testing Aceclidine+tropicamide combination and Aceclidine in people with Presbyopia, run by LENZ Therapeutics, Inc at 1 site in United States.
Trial summary
To evaluate the safety and efficacy of PRX-100 compared with aceclidine alone and vehicle in the treatment of early to moderate presbyopia. Read more about this study
- Who is it for?
- Ages 48 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbyopia
- What is being tested?
- Aceclidine+tropicamide combination and Aceclidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2017to 20 May 2018
- 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 48 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be able and willing to provide written informed consent and sign Health Information Portability and Accountability Act (HIPAA) form prior to any study procedure being performed;
- Be able and willing to follow all instructions and attend study visits;
- Be 48-64 years of age of either sex and any race or ethnicity at visit 1;
- Be an early to moderate presbyope determined by screening monocular best-corrected distance visual acuity (VA) at 45 cm
- Be able and willing to avoid all disallowed medications for the appropriate washout period and during the study without significant risk to the subject.
Who cannot join
- Be a female of childbearing potential who is currently pregnant, nursing or planning a pregnancy;
- Have known contraindications or sensitivity to the use of any of the study medications(s) or their components;
- Have an active ocular infection at visit 1 (bacterial, viral or fungal), positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing, active ocular inflammation (eg, moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis, uveitis) in either eye;
- Have moderate or severe dry eye;
- Have clinically significant abnormal lens findings (eg cataract) including early lens changes and/or any evidence of a media opacity in either eye;
- Have dark-adapted pupillometry measurements of < 4.0 mm in either eye;
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- Have intraocular pressure (IOP) that is less than 5 millimeters of mercury (mmHg) or greater than 22 mmHg in either eye documented at visit 1, or have a prior diagnosis of ocular hypertension or glaucoma or currently being treated with any type of topical IOP lowering (glaucoma) medication at visit 1;
- Have abnormal findings on dilated fundus exam in either eye documented within 3 months of visit 1 or a known history of retinal detachment or clinically significant retinal disease in either eye;
- Have a known history or diagnosis in the past of: iritis, scleritis or uveitis, whether active or inactive;
- Have had surgical intervention (ocular or systemic) within 6 months prior to visit 1, or planned surgical intervention within 30 days after visit 4;
- Have undergone refractive eye surgery (incisional keratotomy, photorefractive keratectomy [PRK], laser in situ keratomileusis [LASIK], laser-assisted sub-epithelial keratectomy [LASEK]), corneal inlay procedures, cataract extraction, or intraocular lens placement;
- Use artificial tears or lubricant eye ointment on a daily basis;
- Have an inability or refuse to discontinue soft contact lens wear 7 days prior to study visit 1 and rigid gas permeable (RGP) contact lens wear 14 days prior to visit 1 and during the study;
- Use any of the following disallowed medications during the 2 weeks (14 days) prior to visit 1 and during the study:
- narcotic (opiate class) pain medication (eg, codeine, OxyContin®, Vicodin®, Tramadol®)
- bladder medication (eg Urecholine®, bethanechol)
- antipsychotics
- antidepressants
- attention -deficit/hyperactivity disorder (ADHD) medications
- alpha-blockers (eg, tamsulosin, Flomax®, Jayln®, Uroxatral®, Rapaflo®)
- anticholinergics (eg, atropine, belladonna, benztropine, dicyclomine, donepezil, hyoscyamine, propantheline, scopolamine, trihexphenidyl)
- muscarinic receptor agonists or cholinergic agonists (eg, Salagen®, Evoxac®)
- over-the-counter (OTC) or prescription antihistamines or decongestants
- any prescribed topical ophthalmic medications
- recreational drug use (eg, marijuana, methadone, heroin, cocaine);
- Have a diagnosis of diabetes mellitus or a history of elevated blood sugar;
- Have a condition or a situation, which in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation, including but not limited to unstable: cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Andover Eye Associates
Andover, Massachusetts, 01810
About this study
To evaluate the safety and efficacy of PRX-100 compared with aceclidine alone and vehicle in the treatment of early to moderate presbyopia.
- Conditions
- Presbyopia
- Being tested
- Aceclidine+tropicamide combination, Aceclidine, Vehicle
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aceclidine+tropicamide combinationDrug
Also called PRX-100
Ophthalmic Solution
AceclidineDrug
Ophthalmic Solution
VehicleDrug
Ophthalmic Solution
| Study group | Role | What they receive |
|---|---|---|
| Aceclidine+tropicamide combination | Experimental | Aceclidine+tropicamide combination single dose (PRX-100 Ophthalmic Solution) Receives: Drug: Aceclidine+tropicamide combination |
| Aceclidine | Active comparator | Aceclidine single dose Receives: Drug: Aceclidine |
| Vehicle | Sham comparator | Vehicle single dose Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects With at Least a 3 Line (15 Letter) Improvement in Near Visual Acuity in the Study Eye
Proportion of subjects with at least a 3 line (15 letter) improvement in near visual acuity in the study eye at 1 hour post-treatment in the mITT population
Measured: 1 hour post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start30 Apr 2017
- Primary completion20 May 2018
- Study completion20 May 2018
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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- LENZ Therapeutics, Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gail Torkildsen, MD, Principal investigator, Andover Eye Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201562
- Sponsor's protocol ID
- PRX100.FDAIIb
- Status last verified
- Sep 2022
- First submitted
- 26 Jun 2017
- Last updated
- 22 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Double-Masked Evaluation of the Efficacy and Safety of PRX-100 in the Treatment of Early to Moderate Presbyopia
- ClinicalTrials.gov ID
- NCT03201562
- Acronym / sponsor ID
- PRX100.FDAIIb
- Conditions
- Presbyopia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- LENZ Therapeutics, IncUniversity, hospital or other
- Study start
- 30 Apr 2017 (actual)
- Primary completion
- 20 May 2018 (actual)
- Study completion
- 20 May 2018 (actual)
- First posted
- 28 Jun 2017 (actual)
- Results
- Posted 19 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and efficacy of PRX-100 compared with aceclidine alone and vehicle in the treatment of early to moderate presbyopia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aceclidine+tropicamide combination | Experimental | Drug: Aceclidine+tropicamide combinationAceclidine+tropicamide combination single dose (PRX-100 Ophthalmic Solution) |
| Aceclidine | Active comparator | Drug: AceclidineAceclidine single dose |
| Vehicle | Sham comparator | Drug: VehicleVehicle single dose |
Who may qualify
- Ages
- 48 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Be able and willing to provide written informed consent and sign Health Information Portability and Accountability Act (HIPAA) form prior to any study procedure being performed;
- Be able and willing to follow all instructions and attend study visits;
- Be 48-64 years of age of either sex and any race or ethnicity at visit 1;
- Be an early to moderate presbyope determined by screening monocular best-corrected distance visual acuity (VA) at 45 cm
- Be able and willing to avoid all disallowed medications for the appropriate washout period and during the study without significant risk to the subject.
Key exclusion criteria (27 listed)
- Be a female of childbearing potential who is currently pregnant, nursing or planning a pregnancy;
- Have known contraindications or sensitivity to the use of any of the study medications(s) or their components;
- Have an active ocular infection at visit 1 (bacterial, viral or fungal), positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing, active ocular inflammation (eg, moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis, uveitis) in either eye;
- Have moderate or severe dry eye;
- Have clinically significant abnormal lens findings (eg cataract) including early lens changes and/or any evidence of a media opacity in either eye;
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 |
|---|---|---|
| Aceclidine+tropicamide combinationAlso: PRX-100Ophthalmic Solution | Drug | Aceclidine+tropicamide combination |
| AceclidineOphthalmic Solution | Drug | Aceclidine |
| VehicleOphthalmic Solution | Drug | Vehicle |
Primary outcome
Proportion of Subjects With at Least a 3 Line (15 Letter) Improvement in Near Visual Acuity in the Study Eye
Time frame: 1 hour post-treatment
Proportion of subjects with at least a 3 line (15 letter) improvement in near visual acuity in the study eye at 1 hour post-treatment in the mITT population
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- 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.
Gail Torkildsen, MD principal investigator
Andover Eye Associates
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 Aceclidine+tropicamide combination and Aceclidine in people with Presbyopia, run by LENZ Therapeutics, Inc 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 5 inclusion and 27 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 22 Sep 2022. 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 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 19 Apr 2021). 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?
Proportion of Subjects With at Least a 3 Line (15 Letter) Improvement in Near Visual Acuity in the Study Eye (time frame: 1 hour post-treatment). 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 22 Sep 2022.