Safety Study: A Multi-Center, Double-Masked Phase 3 Safety Study Evaluation of the Long-Term Safety of LNZ101 in Presbyopic Subjects

22-150-0017

Safety Study of the Long-Term Safety of LNZ101 in Presbyopic Subjects

2023-02-21

2024-02-09

2024-02-09

Completed

Early phase I

361

Inclusion Criteria: 1. 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; 2. Be able and willing to follow all instructions and attend all study visits; 3. Be 45-75 years of age of either sex and any race or ethnicity at Visit 1; 4. Be presbyopic in both eyes as determined by manifest refraction documented at Visit 1; 5. Have +1.00 to -4.00 diopter(D) of sphere calculated in minus cylinder (up to 2.00D of cylinder) in both eyes determined by manifest refraction documented at Visit 1 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 (bacterial, viral, or fungal), positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing, active ocular inflammation in either eye; 4. Have moderate or severe dry eye defined as total corneal fluorescein staining at Visit 1; 5. Have clinically significant abnormal lens findings during dilated slit-lamp biomicroscopy and fundus exam at Visit 1

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A Multi-Center, Double-Masked Phase 3 Evaluation of the Long-Term Safety of LNZ101 in Presbyopic Subjects', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Double-masked treatment will be used to reduce potential of bias during data collection and the evaluation of clinical endpoints.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 361, 'type': 'ACTUAL'}}

2024-03-12