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OpenTrials
Completed

NCT Number: NCT05124275

Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Presbyopia

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 Presbyopia.

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Key information

Conditions

Presbyopia Eye Diseases Refractive Errors

Age range

40 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Glaukos Investigator, Chandler, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presbyopic male or female 40-55 years of age
  • Willing and able to provide written informed consent on the IRB/IEC approved informed consent form

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
  • History of, or active, iritis or uveitis in either eye
  • Pre-existing retinal diseases in either eye that may pre-dispose the subjects to retinal detachment

Treatment and study plan

Pilocarpine Ophthalmic Topical Cream, Dose 1

Drug

Pilocarpine Ophthalmic Topical Cream, Dose 1

Other names: GLK-302

Pilocarpine Ophthalmic Topical Cream, Dose 2

Drug

Pilocarpine Ophthalmic Topical Cream, Dose 2

Other names: GLK-302

Pilocarpine Ophthalmic Topical Cream, Dose 3

Drug

Pilocarpine Ophthalmic Topical Cream, Dose 3

Other names: GLK-302

Placebo Ophthalmic Topical Cream

Drug

Placebo Ophthalmic Topical Cream

Other names: Placebo

Primary outcomes

  1. Binocular Distance Corrected Near Visual Acuity (DCNVA)

    Time frame: Day 28

    Proportion of treatment responders [subjects gaining 3 lines or more in binocular distance corrected near visual acuity (DCNVA) and not losing more than 5 letters of binocular best corrected distance visual acuity (BCDVA)] 1 hour post-dose at the Day 28 visit.

Secondary outcomes

  1. 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.

    Time frame: Day 28

    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.

Sponsors and collaborators

Lead sponsor

Glaukos Corporation

Industry

Registry information

Official study title

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 Presbyopia

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 17, 2021
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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