Status:
COMPLETED
Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Presbyopia
Lead Sponsor:
Corxel Pharmaceuticals
Collaborating Sponsors:
LENZ Therapeutics, Inc
Conditions:
Presbyopia
Near Vision
Eligibility:
All Genders
45-75 years
Phase:
PHASE3
Brief Summary
A Multi-Center, Randomized, Double-Masked, Placebo-Controlled Phase 3 Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Treatment of Presbyopia
Detailed Description
A multicenter, randomized, double-masked, placebo-controlled efficacy and safety study . To evaluate the efficacy and safety of LNZ101 (Aceclidine 1.75%/Brimonidine 0.08%)/LNZ100 (Aceclidine 1.75%) co...
Eligibility Criteria
Inclusion
- Be able and willing to provide written informed consent 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 at Visit 1;
- Have +1.00 to -4.00 diopter (D) of sphere calculated in minus cylinder 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;
- Have +1.00 D to -4.00 D manifest refraction spherical equivalent（MRSE）of Spherical equivalent (SE) determined by manifest refraction documented at Visit 1.
- Be presbyopic as determined at Visit 2 baseline
Exclusion
- 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 (e.g., moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis, uveitis) in either eye;
- Have moderate or severe dry eye at Visit 1, assessed by corneal fluorescein staining;
- Have clinically significant abnormal lens findings (e.g., cataract) including early lens changes and/or any evidence of a media opacity during dilated slitlamp biomicroscopy and fundus exam documented within 3 months of Visit 1 or at Visit 1;
Key Trial Info
Start Date :
September 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 27 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06045299
Start Date
September 27 2023
End Date
January 27 2025
Last Update
March 3 2025
Active Locations (19)
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1
Eye Hospital, Wenzhou Medical University
Wenzhou, Zhejiang, China
2
Beijing Tongren Hospital, Capital Medical University
Beijing, China
3
Peking University First Hospital
Beijing, China
4
The Second Xiangya Hospital of Central South University
Changsha, China