A Safety, Tolerability and Pharmacokinetics Study of R932348 Eye Drops in Patients With Dry Eye Disease

A Phase 1, Single Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Pharmacokinetics, Tolerability and Safety Study of R932348 Ophthalmic Solution in Patients With Mild to Moderate Keratoconjunctivitis Sicca

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01733992

Enrollment

Registered

2012-11-27

Start date

2012-11-30

Completion date

2013-02-28

Last updated

2014-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconjunctivitis Sicca

Brief summary

The purpose of this study is to determine the safety, tolerability and pharmacokinetics of R348 eye drops in patients with dry eye disease.

Detailed description

This is a randomized, double-blind, placebo-controlled single and multiple ascending dose study to evaluate the ocular tolerability, safety, and pharmacokinetics of R348 administered in patients with mild to moderate keratoconjunctivitis sicca (KCS).

Interventions

DRUGR348 Ophthalmic Solution, 0.2%

R348 Ophthalmic Solution, 0.2% single and multiple ascending dose

DRUGR348 Ophthalmic Solution, 0.5%

R348 Ophthalmic Solution, 0.5%, single and multiple ascending dose

DRUGR348 Ophthalmic Solution, 1.0%

R348 Ophthalmic Solution, 1.0%, single and multiple ascending dose

DRUGPlacebo

Placebo, single and multiple ascending dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Mild to moderate Keratoconjunctivitis Sicca. * A corrected visual acuity in both eyes of 20/40 or better. * An intraocular pressure of \< 21 mm Hg with a difference between eyes of \< 6 mm Hg.

Exclusion criteria

* History or evidence of ocular infection, inflammation, or conjunctivitis within 2 months prior to the first dosing day. * History or evidence of blepharitis requiring the use of antibiotics or eye scrubs within 2 months prior to the first dosing day. * History of herpes simplex keratitis at any time. * Current ocular allergy symptoms. * Recent use of eye medications such as steroids or cyclosporine * Refractive eye surgery within 12 months of the first dosing day. * Other eye surgeries within 4 months of the first dosing day. * Current use of contact lenses or discontinuation of contact lens use within 2 weeks of the first dosing day. * Receipt of any blood or blood products within 90 days prior to the first dosing day. * Participation in any clinical study within 30 days prior to the first dosing day. * History of disease, or currently have a significant illness or abnormal laboratory finding as determined by your study doctor. * Positive for hepatitis B, hepatitis C or HIV. * Smoked regularly within 12 months of first dosing day. * History of substance abuse, drug addiction or alcoholism.

Design outcomes

Primary

Measure	Time frame
Change in corneal fluorescein staining	Baseline and Visits 4, 8 and 12

Secondary

Measure	Time frame
Change in conjunctival lissamine green staining	Baseline and Visits 4, 8 and 12

Other

Measure	Time frame
Change in Schirmer test	Baseline and Visits 4, 8 and 12

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026