Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Presbyopia

Glaukos

Status and phase: Completed; Phase 2

Conditions: Presbyopia

Treatments: Drug: Placebo Ophthalmic Topical Cream; Drug: Pilocarpine Ophthalmic Topical Cream, Dose 3; Drug: Pilocarpine Ophthalmic Topical Cream, Dose 2; Drug: Pilocarpine Ophthalmic Topical Cream, Dose 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT05124275

ILUT-401-PRES

Details and patient eligibility

About

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.

Enrollment: 123 patients

Sex: All

Ages: 40 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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123 participants in 4 patient groups, including a placebo group

Pilocarpine Ophthalmic Topical Cream, Dose 1

Experimental group

Description:

Pilocarpine Ophthalmic Topical Cream, Dose 1

Treatment:

Drug: Pilocarpine Ophthalmic Topical Cream, Dose 1

Pilocarpine Ophthalmic Topical Cream, Dose 2

Experimental group

Description:

Pilocarpine Ophthalmic Topical Cream, Dose 2

Treatment:

Drug: Pilocarpine Ophthalmic Topical Cream, Dose 2

Pilocarpine Ophthalmic Topical Cream, Dose 3

Experimental group

Description:

Pilocarpine Ophthalmic Topical Cream, Dose 3

Treatment:

Drug: Pilocarpine Ophthalmic Topical Cream, Dose 3

Placebo Ophthalmic Topical Cream

Placebo Comparator group

Description:

Placebo Ophthalmic Topical Cream

Treatment:

Drug: Placebo Ophthalmic Topical Cream