PresbyopiaPhase 2NCT05294328

Evaluation of the Safety and Effectiveness of Aceclidine/Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia

A Phase 2 study testing Aceclidine+Brimonidine combination ophthalmic solution and Aceclidine ophthalmic solution in people with Presbyopia and Refractive Errors, run by LENZ Therapeutics, Inc at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the safety and effectiveness of Aceclidine/Brimonidine (LNZ101) compared with Aceclidine (LNZ100) and vehicle in the treatment of Presbyopia. Read more about this study

Who is it for?: Ages 45 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Presbyopia, Refractive Errors, Eye Diseases
What is being tested?: Aceclidine+Brimonidine combination ophthalmic solution and Aceclidine ophthalmic solution
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 5 sitesUnited States
Study dates: 5 May 2022to 10 Sep 2022
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 45 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects MUST:
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 45-75 years of age of either sex and any race or ethnicity at Visit 1;
Have +1.00 to -4.00 diopter (D) of sphere (so that SE results in myopia no more severe than -4.00 SE. See Inclusion 5 below) in both eyes determined by manifest refraction documented at Visit 1;
Have up to 2.00D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1;
Be presbyopic as determined at Visit 1

Who cannot join

Subjects must NOT:
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 (e.g., moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis, uveitis) in either eye;
Have moderate or severe dry eye determined by total corneal fluorescein staining at Visit 1;
Have clinically significant abnormal lens findings (e.g., cataract) including early lens changes and/or any evidence of a media opacity in either eye during dilated slit-lamp biomicroscopy and fundus exam documented within 3 months of Visit 1;

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

INSIGHT-1 Study Site #1
Andover, Massachusetts, 01810
INSIGHT-1 Study Site #4
Glendale, California, 91204
INSIGHT-1 Study Site #5
Houston, Texas, 77027
INSIGHT-1 Study Site #3
Indianapolis, Indiana, 46240
INSIGHT-1 Study Site #2
Memphis, Tennessee, 38119

Other trials in United States

About this study

Official title: A Multicenter, Double-Masked Evaluation of the Safety and Effectiveness of Aceclidine /Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia

To evaluate the safety and effectiveness of Aceclidine/Brimonidine (LNZ101) compared with Aceclidine (LNZ100) and vehicle in the treatment of Presbyopia.

Conditions: Presbyopia, Refractive Errors, Eye Diseases
Being tested: Aceclidine+Brimonidine combination ophthalmic solution, Aceclidine ophthalmic solution, Vehicle Proprietary Ophthalmic Solution
Keywords: Pharmaceutical Solutions, Miotics, Ophthalmic Solutions, Near Vision, Eye Drops, INSIGHT 1
Medical subject headings: Presbyopia, Refractive Errors, Eye Diseases, Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Aceclidine+Brimonidine combination ophthalmic solutionDrug
Also called LNZ101, Brimonidine and Aceclidine
LNZ101-combination ophthalmic solution
Aceclidine ophthalmic solutionDrug
Also called LNZ100, Aceclidine
LNZ100- aceclidine ophthalmic solution
Vehicle Proprietary Ophthalmic SolutionDrug
Also called Vehicle
Proprietary Vehicle Ophthalmic Solution

Study groups in NCT05294328
Study group	Role	What they receive
Combination ophthalmic solution (LNZ101) dosed bilaterally	Experimental	LNZ101: Aceclidine/Brimonidine combination ophthalmic solution Receives: Drug: Aceclidine+Brimonidine combination ophthalmic solution
Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally	Experimental	LNZ100: Aceclidine ophthalmic solution Receives: Drug: Aceclidine ophthalmic solution
Vehicle Ophthalmic Solution dosed bilaterally	Experimental	Proprietary Vehicle ophthalmic solution Receives: Drug: Vehicle Proprietary Ophthalmic Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With a ≥ 3-line Improvement in Near Vision and no Loss ≥ 5 Letters Distance Vision
Percentage of participants with at least a 3-line improvement in near vision and no loss ≥ 5 letters distance vision
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.

5 May 202210 Sep 2022

First posted24 Mar 2022
Study start5 May 2022
Primary completion22 Aug 2022
Study completion10 Sep 2022

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
Model description: Multicenter, double-masked, randomized, crossover, active and vehicle-controlled, safety and effectiveness study
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05294328
Sponsor's protocol ID: 21-100-0007
Status last verified: Aug 2024
First submitted: 4 Mar 2022
Last updated: 5 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
Presbyopia

All Presbyopia trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Double-Masked Evaluation of the Safety and Effectiveness of Aceclidine /Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia
ClinicalTrials.gov ID: NCT05294328
Acronym / sponsor ID: 21-100-0007
Conditions: Presbyopia, Refractive Errors, Eye Diseases
Keywords: Pharmaceutical Solutions, Miotics, Ophthalmic Solutions, Near Vision, Eye Drops, INSIGHT 1
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: LENZ Therapeutics, IncUniversity, hospital or other
Study start: 5 May 2022 (actual)
Primary completion: 22 Aug 2022 (actual)
Study completion: 10 Sep 2022 (actual)
First posted: 24 Mar 2022 (actual)
Results: Posted 5 Sep 2024

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 effectiveness of Aceclidine/Brimonidine (LNZ101) compared with Aceclidine (LNZ100) and vehicle in the treatment of Presbyopia.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3
Model description: Multicenter, double-masked, randomized, crossover, active and vehicle-controlled, safety and effectiveness study

Arm	Type	Receives
Combination ophthalmic solution (LNZ101) dosed bilaterally	Experimental	Drug: Aceclidine+Brimonidine combination ophthalmic solutionLNZ101: Aceclidine/Brimonidine combination ophthalmic solution
Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally	Experimental	Drug: Aceclidine ophthalmic solutionLNZ100: Aceclidine ophthalmic solution
Vehicle Ophthalmic Solution dosed bilaterally	Experimental	Drug: Vehicle Proprietary Ophthalmic SolutionProprietary Vehicle ophthalmic solution

Who may qualify

Ages: 45 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 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 45-75 years of age of either sex and any race or ethnicity at Visit 1;
Have +1.00 to -4.00 diopter (D) of sphere (so that SE results in myopia no more severe than -4.00 SE. See Inclusion 5 below) in both eyes determined by manifest refraction documented at Visit 1;
Have up to 2.00D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1;

Key exclusion criteria (6 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 (e.g., moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis, uveitis) in either eye;
Have moderate or severe dry eye determined by total corneal fluorescein staining at Visit 1;
Have clinically significant abnormal lens findings (e.g., cataract) including early lens changes and/or any evidence of a media opacity in either eye during dilated slit-lamp biomicroscopy and fundus exam documented within 3 months of Visit 1;

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+Brimonidine combination ophthalmic solutionAlso: LNZ101, Brimonidine and AceclidineLNZ101-combination ophthalmic solution	Drug	Combination ophthalmic solution (LNZ101) dosed bilaterally
Aceclidine ophthalmic solutionAlso: LNZ100, AceclidineLNZ100- aceclidine ophthalmic solution	Drug	Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterally
Vehicle Proprietary Ophthalmic SolutionAlso: VehicleProprietary Vehicle Ophthalmic Solution	Drug	Vehicle Ophthalmic Solution dosed bilaterally

Primary outcome

Percentage of Participants With a ≥ 3-line Improvement in Near Vision and no Loss ≥ 5 Letters Distance Vision
Time frame: 1 hour post treatment
Percentage of participants with at least a 3-line improvement in near vision and no loss ≥ 5 letters distance vision

Results and safety

Results posted to the registry on 5 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Crossover Sequence 1 (123)	22	20
Crossover Sequence 2 (231)	22	18
Crossover Sequence 3 (312)	24	23

Primary outcome: Percentage of Participants With a ≥ 3-line Improvement in Near Vision and no Loss ≥ 5 Letters Distance Vision

Time frame: 1 hour post treatment. Number. Unit: percentage of participants

Measure	LNZ101 n = 50	LNZ100 n = 49	Vehicle Ophthalmic Solution n = 51
Value	56.0	71.4	5.9

LNZ101 vs Vehicle Ophthalmic Solution: Odds Ratio (OR): 34.262, p <0.0001, Generalized Estimating Equation (GEE)
LNZ100 vs Vehicle Ophthalmic Solution: Odds Ratio (OR): 73.443, p <0.0001, Generalized Estimating Equation (GEE)

Population analysed: The treatment crossover design allowed for each treatment to be analyzed in all subjects. The primary efficacy analysis was performed on a mITT population of subjects meeting the baseline criteria.

Adverse events

Time frame: Approximately 3 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LNZ101	0 of 62 (0%)	9 of 62 (14.5%)	0 of 62
LNZ100	0 of 62 (0%)	3 of 62 (4.8%)	0 of 62
Vehicle Ophthalmic Solution	0 of 61 (0%)	8 of 61 (13.1%)	0 of 61

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Presbyopia

Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
Presbyopia

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.

Alisyn Facemire, BA study director

LENZ Therapeutics, Inc

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 6 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 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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. 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 5 Sep 2024). 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 a ≥ 3-line Improvement in Near Vision and no Loss ≥ 5 Letters Distance Vision (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?

On the ClinicalTrials.gov record for NCT05294328.

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 5 Sep 2024.