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Completed

NCT Number: NCT05119920

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

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.

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Key information

Conditions

Dry Eye Disease Conjunctival Diseases Conjunctivitis Corneal Diseases Dry Eye Syndromes Eye Diseases Keratitis Kerato Conjunctivitis Sicca Keratoconjunctivitis Lacrimal Apparatus Diseases

Age range

18 year and older

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

  • 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

Treatment and study plan

Pilocarpine Ophthalmic Topical Cream, Dose 1

Drug

Pilocarpine Ophthalmic Topical Cream, Dose 1

Other names: GLK-301

Pilocarpine Ophthalmic Topical Cream, Dose 2

Drug

Pilocarpine Ophthalmic Topical Cream, Dose 2

Other names: GLK-301

Pilocarpine Ophthalmic Topical Cream, Dose 3

Drug

Pilocarpine Ophthalmic Topical Cream, Dose 3

Other names: GLK-301

Placebo Ophthalmic Topical Cream

Drug

Placebo Ophthalmic Topical Cream

Other names: Placebo

Primary outcomes

  1. Mean change from baseline in the VAS score at Day 28 visit.

    Time frame: 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)

  2. Mean change from baseline in Fluorescein Staining at the Day 28 visit.

    Time frame: Baseline and Day 28

    Mean change from baseline in Fluorescein Staining at the Day 28 visit.

Secondary outcomes

  1. Mean change from baseline in the VAS score at the Day 4, 8, and 14 visits

    Time frame: 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)

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 Signs and Symptoms of Dry Eye Disease

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 15, 2021
Registry last updated
Jul 12, 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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