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

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 Signs and Symptoms of Dry Eye Disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05119920

Enrollment

226

Registered

2021-11-15

Start date

2022-01-03

Completion date

2022-07-27

Last updated

2023-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Disease, Kerato Conjunctivitis Sicca

Keywords

Dry eye syndromes, Eye diseases, Corneal diseases, Keratoconjunctivitis, Pilocarpine

Brief summary

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.

Interventions

DRUGPilocarpine Ophthalmic Topical Cream, Dose 1

Pilocarpine Ophthalmic Topical Cream, Dose 1

DRUGPilocarpine Ophthalmic Topical Cream, Dose 2

Pilocarpine Ophthalmic Topical Cream, Dose 2

DRUGPilocarpine Ophthalmic Topical Cream, Dose 3

Pilocarpine Ophthalmic Topical Cream, Dose 3

DRUGPlacebo Ophthalmic Topical Cream

Placebo Ophthalmic Topical Cream

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Mean change from baseline in the VAS score at Day 28 visit.	Baseline and Day 28	Mean change from baseline in the VAS score at Day 28 visit. Visual Analogue Scale from 0 (no discomfort) to 100 (maximal discomfort)
Mean change from baseline in Fluorescein Staining at the Day 28 visit.	Baseline and Day 28	Mean change from baseline in Fluorescein Staining at the Day 28 visit.

Secondary

Measure	Time frame	Description
Mean change from baseline in the VAS score at the Day 4, 8, and 14 visits	Baseline and Days 4, 8, and 14	Mean change from baseline in the VAS score at the Day 4, 8, and 14 visits Visual Analogue Scale from 0 (no discomfort) to 100 (maximal discomfort)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026