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

ReGenTree

Status and phase: Completed; Phase 3

Conditions: Dry Eye; Dry Eye Syndromes

Treatments: Drug: Placebo; Drug: RGN-259

Study type: Interventional

Funder types: Industry

Identifiers

NCT03937882

RGN-259/19-110-0002

Details and patient eligibility

About

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.

Enrollment: 700 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

700 participants in 2 patient groups, including a placebo group

RGN-259

Experimental group

Description:

RGN-259: It is a preservative-free, sterile eye drop solution containing Thymosin beta 4

Treatment:

Drug: RGN-259

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo