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Cholinergic Agonist

Pilocarpine Ophthalmic Topical Cream, Dose 2 for Presbyopia

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
Presbyopic male or female 40-55 years of age
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 28
Awards & highlights

Study Summary

This trial is testing whether a cream containing the drug pilocarpine is safe and effective for treating presbyopia, a condition that causes difficulty reading up close.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are a man or woman between the ages of 40 and 55 who has difficulty seeing things close up.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Binocular Distance Corrected Near Visual Acuity (DCNVA)
Secondary outcome measures
Proportion of treatment responders (as defined for the primary endpoint) at 0.5, 2, 4, and 6 hours post-dose at the day 28 visit.

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 2
2022
Completed Phase 2
~350
Pilocarpine Ophthalmic Topical Cream, Dose 1
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
8,917 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical research require additional participants?

"This research is currently seeking participants, with the first posting date on March 1st 2022 and a recent update made on May 11th 2022. This information can be found on clinicaltrials.gov"

Answered by AI

Is my profile compatible with the prerequisites for taking part in this medical experiment?

"This medical trial is accepting patients aged 40-55 who suffer from presbyopia, with a total of 120 individuals required."

Answered by AI

What medical purpose does Pilocarpine Ophthalmic Topical Cream, Dose 2 typically serve?

"Pilocarpine Ophthalmic Topical Cream, Dose 2 has the potential to remediate radiotherapy-related issues, miosis (constricted pupil), and presbyopia."

Answered by AI

What is the total enrollment capacity for this medical research project?

"Correct. Clinicaltrials.gov affirms that this medical investigation, which was first made available on the 3rd of January 2022, is currently enrolling participants. Around 120 people need to be recruited from 10 distinct sites."

Answered by AI

What potential risks have been associated with using Pilocarpine Ophthalmic Topical Cream, Dose 2?

"Based on the available evidence, our analysts have assigned a score of 2 to Pilocarpine Ophthalmic Topical Cream's safety profile. This is because this is a Phase 2 trial and there are data points that suggest its security but no efficacy studies exist yet."

Answered by AI

Are individuals aged 40 and above being included in this experimentation?

"This study is seeking participants aged 40 years and above, but below 55."

Answered by AI

Are there historical accounts of experiments with Pilocarpine Ophthalmic Topical Cream, Dose 2?

"Presently, there are 3 clinical trials for Pilocarpine Ophthalmic Topical Cream, Dose 2; one of which is at the final Phase 3 stage. While all studies take place in Glendale, California - 13 medical centres across the region are running tests and collecting data."

Answered by AI

How many healthcare centers are actively participating in this trial?

"This clinical trial currently has 10 participating centres, located in cities such as Louisville, San Antonio and Sun City. It is recommended to choose the nearest site when enrolling in order to minimize travelling costs."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Glaukos Investigator
What portion of applicants met pre-screening criteria?
Met criteria
~39 spots leftby Mar 2025