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Cholinergic Agonist

Pilocarpine Ophthalmic Topical Cream, Dose 2 for Dry Eye Syndrome

Phase 2
Waitlist Available
Research Sponsored by Glaukos Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and days 4, 8, and 14
Awards & highlights

Study 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.

Eligible Conditions
  • Dry Eye Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and days 4, 8, and 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and days 4, 8, and 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change from baseline in Fluorescein Staining at the Day 28 visit.
Mean change from baseline in the VAS score at Day 28 visit.
Secondary outcome measures
Mean change from baseline in the VAS score at the Day 4, 8, and 14 visits

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Pilocarpine Ophthalmic Topical Cream, Dose 3Experimental Treatment1 Intervention
Pilocarpine Ophthalmic Topical Cream, Dose 3
Group II: Pilocarpine Ophthalmic Topical Cream, Dose 2Experimental Treatment1 Intervention
Pilocarpine Ophthalmic Topical Cream, Dose 2
Group III: Pilocarpine Ophthalmic Topical Cream, Dose 1Experimental Treatment1 Intervention
Pilocarpine Ophthalmic Topical Cream, Dose 1
Group IV: Placebo Ophthalmic Topical CreamPlacebo Group1 Intervention
Placebo Ophthalmic Topical Cream
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pilocarpine Ophthalmic Topical Cream, Dose 1
2022
Completed Phase 2
~350
Pilocarpine Ophthalmic Topical Cream, Dose 2
2022
Completed Phase 2
~350
Pilocarpine Ophthalmic Topical Cream, Dose 3
2022
Completed Phase 2
~350

Find a Location

Who is running the clinical trial?

Glaukos CorporationLead Sponsor
65 Previous Clinical Trials
8,814 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Dry Eye Disease
2022. "Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Dry Eye Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05119920.
~70 spots leftby Apr 2025
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