Clinical trial NCT06045299: Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Presbyopia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Presbyopia
Near Vision
Miosis
Eye Diseases
Keywords: Presbyopia
Pharmaceutical Solutions
Opthalmic Solutions
Eye Drops
Miotic
Lead sponsor: Corxel Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: LENZ Therapeutics, Inc
First posted: 2023-09-21
Enrollment: 300
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%) compared with placebo for the treatment of presbyopia.

Eligibility criteria: Inclusion Criteria:

1. Be able and willing to provide written informed consent prior to any study procedure being performed;
2. Be able and willing to follow all instructions and attend all study visits;
3. Be 45-75 years of age of either sex at Visit 1;
4. 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;
5. Have ≤2.00 D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1;
6. 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.
7. Be presbyopic as determined at Visit 2 baseline

Exclusion Criteria:

1. Be a female of childbearing potential who is currently pregnant, nursing, or planning a pregnancy;
2. Have known contraindications or sensitivity to the use of any of the study medications or their components;
3. 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;
4. Have moderate or severe dry eye at Visit 1, assessed by corneal fluorescein staining;
5. 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;

Primary outcomes:
measure: Best-corrected distance visual acuity (BCDVA) at 40 cm
timeFrame: 3 hours post-treatment in the study eye at Visit 2 (Day 1）
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Eye Hospital, Wenzhou Medical University
state: Zhejiang
city: Beijing
country: China
facility: Beijing Tongren Hospital, Capital Medical University
city: Beijing
country: China
facility: Peking University First Hospital
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
city: Chengdu
country: China
facility: Ineye Hospital of Chengdu University of TCM
city: Dalian
country: China
facility: Dalian N0.3 people's hospital
city: Guangzhou
country: China
facility: Guang Zhou Aier eye Hospital
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
city: Jinan
country: China
facility: Affiliated Eye Hospital, Shandong University of Traditional Chinese Medicine
city: Shanghai
country: China
facility: Shanghai Eye Disease Prevention and Treatment Center
city: Shanghai
country: China
facility: Tongji Hospital Of Tongji University
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School Of Medicine
city: Taiyuan
country: China
facility: Shanxi Eye Hospital
city: Tianjin
country: China
facility: Tianjin Eye Hospital
city: Tianjin
country: China
facility: Tianjin Medical University Eye Hospital
city: Wuhan
country: China
facility: Wuhan Aier Eye Hospital
city: Xi'an
country: China
facility: Xi'An People's Hospital
city: Zhengzhou
country: China
facility: Henan Eye Hospital & Henan Institute
Study officials:
affiliation: Corxel Pharmaceuticals
name: Gloria Sun
role: STUDY_DIRECTOR
References: