PresbyopiaPhase 3CLARITY 2NCT05728944
Phase 3 Efficacy Study of LNZ100 & LNZ101 for the Treatment of Presbyopia
A Phase 3 study testing Aceclidine+Brimonidine combination ophthalmic solution and Aceclidine ophthalmic solution in people with Presbyopia and Near Vision, run by LENZ Therapeutics, Inc at 17 sites in United States.
Trial summary
Phase 3 Efficacy Study to evaluate the Safety and Efficacy of LNZ100 \& LNZ101 for 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, Near Vision, Refractive Error
- 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
- 229 participants
- Where
- 17 sitesUnited States
- Study dates
- 6 Mar 2023to 24 Jan 2024
- Phase
- Phase 3
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
- Be able and willing to provide written informed consent and sign a 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 all 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 calculated in minus cylinder (so that spherical equivalent (SE) results in myopia no more severe than -4.00 D MRSE) in both eyes determined by manifest refraction documented at Visit 1;
- Have ≤2.00 D 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
- 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 or their components;
- Have an active ocular infection at Visit 1 or at Visit 2 (bacterial, viral, or fungal), positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing, active ocular inflammation in either eye;
- Have moderate or severe dry eye defined as total central corneal fluorescein staining in either eye at Visit 1;
- Have clinically significant abnormal lens findings including early lens changes during dilated slit lamp biomicroscopy and fundus exam documented within 3 months of Visit 1 or at Visit 1;
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Site #215
Bozeman, Montana, 59718
Site #205
Crystal River, Florida, 34429
Site #204
Danbury, Connecticut, 06810
Site #209
Dothan, Alabama, 36301
Site #219
Dover, New Jersey, 07801
Site #213
Eugene, Oregon, 97401
Site #220
Glendale, California, 91204
Site #214
La Jolla, California, 92037
Site #211
Louisville, Kentucky, 40206
Site #203
Newport Beach, California, 92663
Site #218
Northbrook, Illinois, 60062
Site #207
Powell, Ohio, 43065
Site #221
Rochester, New York, 14626
Site #216
Scottsdale, Arizona, 85260
Site #208
St Louis, Missouri, 63128
Site #217
Warwick, Rhode Island, 02888
Site #212
West Fargo, North Dakota, 58078
About this study
Official title: A Multi-Center, Double-Masked Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia
Phase 3 Efficacy Study to evaluate the Safety and Efficacy of LNZ100 \& LNZ101 for the Treatment of Presbyopia
Read the detailed description
Phase 3 study to evaluate the safety and effectiveness of LNZ101 compared with LNZ100 and Vehicle for the treatment of Presbyopia.
- Conditions
- Presbyopia, Near Vision, Refractive Error, Eye Diseases
- Being tested
- Aceclidine+Brimonidine combination ophthalmic solution, Aceclidine ophthalmic solution, Vehicle
- Keywords
- Pharmaceutical Solutions, Ophthalmic Solutions, Eye Drops, CLARITY, Presbyopia, Miotics
- Medical subject headings
- Presbyopia, Myopia, Refractive Errors, Eye Diseases
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
Aceclidine + Brimonidine combination ophthalmic solution
Aceclidine ophthalmic solutionDrug
Also called LNZ100
Aceclidine ophthalmic solution
VehicleDrug
Proprietary vehicle ophthalmic solution
| Study group | Role | What they receive |
|---|---|---|
| Aceclidine + Brimonidine (LNZ101) dosed bilaterally | Experimental | LNZ101: Aceclidine + Brimonidine 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 | Vehicle ophthalmic solution Receives: Drug: Vehicle |
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 on Day 1
Measured: 3 hours post-treatment in the study eye on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start6 Mar 2023
- Primary completion14 Dec 2023
- Study completion24 Jan 2024
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multi-center, double masked, randomized, controlled, efficacy and safety study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- LENZ Therapeutics, Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kris Gambelin, BS, Study director, LENZ Therapeutics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728944
- Sponsor's protocol ID
- 22-150-0018
- Acronym
- CLARITY 2
- Status last verified
- May 2026
- First submitted
- 6 Feb 2023
- Last updated
- 8 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No