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

JX07001

Phase 3 Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Treatment of Presbyopia

2023-09-27

2024-07-31

2024-12-31

Recruiting

Early phase I

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;

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}

2023-10-26