Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Dry Eye Disease

Glaukos

Status and phase: Completed; Phase 2

Conditions: Dry Eye Disease; Kerato Conjunctivitis Sicca

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05119920

ILUT-401-DED

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 Signs and Symptoms of Dry Eye Disease.

Enrollment: 226 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, 18 years of age or older at the Screening Visit
• Willing and able to provide written informed consent on the IRB/IEC-approved informed consent form
• Diagnosis of dry eye

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 such as lotions, creams, makeup, soaps, etc.
• History of, or active iritis or uveitis in either eye
• Pre-existing retinal disease in either eye that may predispose subjects to retinal detachment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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226 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