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

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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

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

Trial contacts and locations

19

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Data sourced from clinicaltrials.gov

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