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

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

Study Overview

• Status: Completed
• Conditions: Keratoconjunctivitis Sicca
• Intervention / Treatment: Drug: R348 Ophthalmic Solution, 0.2%; Drug: Placebo; Drug: R348 Ophthalmic Solution, 0.5%; Drug: R348 Ophthalmic Solution, 1.0%

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).

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: R348 Ophthalmic Solution, 0.2%; R348 Ophthalmic Solution, 0.2%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day.	Drug: R348 Ophthalmic Solution, 0.2%; R348 Ophthalmic Solution, 0.2% single and multiple ascending dose; Other Names: R932348; Drug: Placebo; Placebo, single and multiple ascending dose
Active Comparator: R348 Ophthalmic Solution, 0.5%; R348 Ophthalmic Solution, 0.5%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day.	Drug: Placebo; Placebo, single and multiple ascending dose; Drug: R348 Ophthalmic Solution, 0.5%; R348 Ophthalmic Solution, 0.5%, single and multiple ascending dose; Other Names: R932348
Active Comparator: R348 Ophthalmic Solution, 1.0%; R348 Ophthalmic Solution, 1.0%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day.	Drug: Placebo; Placebo, single and multiple ascending dose; Drug: R348 Ophthalmic Solution, 1.0%; R348 Ophthalmic Solution, 1.0%, single and multiple ascending dose; Other Names: R932348
Placebo Comparator: Placebo; Placebo, single (1 day) or multiple ascending dose (13 days) followed by a single dose on the fourteenth day.	Drug: Placebo; Placebo, single and multiple ascending dose

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rigel Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: November 21, 2012
• First Submitted That Met QC Criteria: November 26, 2012
• First Posted (Estimate): November 27, 2012

Study Record Updates

• Last Update Posted (Estimate): August 4, 2014
• Last Update Submitted That Met QC Criteria: July 31, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Keratoconjunctivitis; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: C-932348-002