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Completed

NCT Number: NCT03937882

Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3

The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.

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Key information

Conditions

Dry Eye Syndromes Dry Eye Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cornea and Cataract Consultants of Arizona, Phoenix, 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

  • Be at least 18 years of age;
  • Provide written informed consent;
  • Have a subject reported history of dry eye for at least 6 months;
  • Have a history of use or desire to use eye drops for dry eye symptoms within 6 months

Exclusion criteria

  • Have any clinically significant slit-lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
  • Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
  • Have an uncontrolled systemic disease;
  • Be a woman who is pregnant, nursing or planning a pregnancy

Treatment and study plan

RGN-259

Drug

A preservative-free, sterile eye drop solution containing Thymosin beta 4 for direct instillation into each eye, four times a day (QID) for 14 days

Other names: Tβ4, Thymosin Beta 4

Placebo

Drug

It is composed of the same excipients as RGN-259 but does not contain Thymosin beta 4

Other names: Vehicle Control

Primary outcomes

  1. Corneal staining

    Time frame: 15 days after first dosing

    Mean change from baseline to Day 15 of Inferior Corneal Fluorescein Staining

  2. Ocular Discomfort 6-point (0=none, 5=worst) scale

    Time frame: 15 days after first dosing

    Mean change from baseline to Day 15 of Ocular Discomfort severity

Sponsors and collaborators

Lead sponsor

ReGenTree, LLC

Industry

Registry information

Official study title

A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of RGN-259 Ophthalmic Solutions for the Treatment of Dry Eye (ARISE-3)

Acronym: ARISE-3

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
May 6, 2019
Registry last updated
May 9, 2022

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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