Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream BID for the Treatment of Presbyopia

ILUT-401-PRES

This is a Multicenter, Randomized, Double-Masked Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Presbyopia.

2022-01-03

2022-09-06

2022-09-06

Completed

Early phase I

123

Inclusion Criteria: * Presbyopic male or female 40-55 years of age * Willing and able to provide written informed consent on the IRB/IEC approved informed consent form Exclusion Criteria: * Sensitivity or known allergy to pilocarpine or any of the other excipients of the formulation * History of eczema, dermatitis or skin sensitivity to over-the-counter personal care products * History of, or active, iritis or uveitis in either eye * Pre-existing retinal diseases in either eye that may pre-dispose the subjects to retinal detachment

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 123, 'type': 'ACTUAL'}}

2023-09-01