Phase 3
N=362
Phase 3 Safety Study of LNZ100 and LNZ101 for the Treatment of Presbyopia Subjects
Presbyopia · Near Vision · Refractive Error · Eye Diseases
Bottom Line
View on ClinicalTrials.gov: NCT05753189 ↗Enrolled (actual)
362
Serious AEs
1.1%
Results posted
May 2026
Primary outcome: Primary: Number of Participants With at Least One Treatment-Related TEAE — 101; 75; 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aceclidine+Brimonidine combination ophthalmic solution (Drug); Aceclidine ophthalmic solution (Drug); Vehicle (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- LENZ Therapeutics, Inc
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With at Least One Treatment-Related TEAE |
101; 75; 17 | — |
Summary
Safety Study of the Long-Term Safety of LNZ100 & LNZ101 in Presbyopic Subjects
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05753189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.