RGN-259 in severe dry eye

Study record

Population

Nine patients; results reported for 12 active-treated eyes and six control eyes. Eyes are not independent participant counts.

Read source · Abstract-level extractionPrimary abstract — study methods and findings

Formulation

0.1% RGN-259 versus vehicle eye drops.

Read source · Abstract-level extractionPrimary abstract — study methods and findings

Route

Ophthalmic.

Read source · Abstract-level extractionPrimary abstract — study methods and findings

Dose & frequency

Six applications daily for 28 days; establishes no human or KLOW regimen for systemic products.

Read source · Abstract-level extractionPrimary abstract — study methods and findings

Study design

Small two-site randomized double-masked phase 2 trial, NCT01393132.

Read source · Abstract-level extractionPrimary abstract — study methods and findings

Duration

28-day treatment plus 28-day follow-up; 56 days total.

Read source · Abstract-level extractionPrimary abstract — study methods and findings

Reported findings

Day-56 symptom and corneal-staining measures favored RGN-259. Multiple timepoints and eye-based reporting require full statistical context.

Read source · Abstract-level extractionPrimary abstract — study methods and findings

Adverse events

Separate adverse-event module also reports zero serious and nonserious events, denominators six/three. This short, nine-person study cannot establish general safety.

Read source · Registry resultsResults — Primary safety outcome; Adverse Events

Monitoring

Registry describes intraocular pressure by applanation tonometry, complete ophthalmologic examination including fundoscopy, and adverse-event assessment at days 1, 14, 28 and 56.

Read source · Registry resultsResults — Primary outcome description: Safety