Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Presbyopia

Phase 3

Completed

• Conditions: Presbyopia; Near Vision; Miosis; Eye Diseases
• Interventions: Drug: Aceclidine ophthalmic solution; Drug: Placebo (Vehicle) ophthalmic solution; Drug: Aceclidine+Brimonidine combination ophthalmic solution

• Registration Number: NCT06045299
• Lead Sponsor: Corxel Pharmaceuticals

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.

Study Timeline

• Study First Submitted: 2023-09-13
• Study First Submitted QC: 2023-09-19
• Study First Posted: 2023-09-21
• Study Start: 2023-09-27
• Primary Completion: 2024-08-19
• Status Verified: 2024-09
• Study Completion: 2025-01-27
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LNZ100 (Aceclidine) ophthalmic solution	Aceclidine ophthalmic solution	Enrolled subjects will be randomized to receive LNZ101, LNZ100, or placebo bilaterally once a day. Subjects will be instructed to dose 2 drops in both eyes (OU) (1 drop followed by 2 minutes later, another drop). Subjects will dose for 168 days.
Placebo (Vehicle) ophthalmic solution	Placebo (Vehicle) ophthalmic solution	Enrolled subjects will be randomized to receive LNZ101, LNZ100, or placebo bilaterally once a day. Subjects will be instructed to dose 2 drops in both eyes (OU) (1 drop followed by 2 minutes later, another drop). Subjects will dose for 168 days.
LNZ101 (Aceclidine/Brimonidine) ophthalmic solution	Aceclidine+Brimonidine combination ophthalmic solution	Enrolled subjects will be randomized to receive LNZ101, LNZ100, or placebo bilaterally once a day. Subjects will be instructed to dose 2 drops in both eyes (OU) (1 drop followed by 2 minutes later, another drop). Subjects will dose for 168 days.

Primary Outcome Measures

Name	Time	Method
Best-corrected distance visual acuity (BCDVA) at 40 cm	3 hours post-treatment in the study eye at Visit 2 (Day 1）	Percentage of subjects who achieve a 3-line (15-letter) or greater improvement from baseline in the measurement of monocular BCDV at 40 cm and no loss in BCDVA ≥ 5 letters (ETDRS chart at 4 m)

Trial Locations

Locations (19)

Dalian N0.3 people's hospital; 🇨🇳 Dalian, China

Guang Zhou Aier eye Hospital; 🇨🇳 Guangzhou, China

Henan Eye Hospital & Henan Institute; 🇨🇳 Zhengzhou, China

Ineye Hospital of Chengdu University of TCM; 🇨🇳 Chengdu, China

Eye Hospital, Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China

Beijing Tongren Hospital, Capital Medical University; 🇨🇳 Beijing, China

Peking University First Hospital; 🇨🇳 Beijing, China

The Second Xiangya Hospital of Central South University; 🇨🇳 Changsha, China

Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, China

The Affiliated Hospital of Guizhou Medical University; 🇨🇳 Guiyang, China

Affiliated Eye Hospital, Shandong University of Traditional Chinese Medicine; 🇨🇳 Jinan, China

Shanghai Eye Disease Prevention and Treatment Center; 🇨🇳 Shanghai, China

Tongji Hospital Of Tongji University; 🇨🇳 Shanghai, China

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School Of Medicine; 🇨🇳 Shanghai, China

Shanxi Eye Hospital; 🇨🇳 Taiyuan, China

Tianjin Eye Hospital; 🇨🇳 Tianjin, China

Tianjin Medical University Eye Hospital; 🇨🇳 Tianjin, China

Wuhan Aier Eye Hospital; 🇨🇳 Wuhan, China

Xi'An People's Hospital; 🇨🇳 Xi'an, China