To Assess the Safety and Efficacy of R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca (DROPS)

A Phase 2, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of 0.2% and 0.5% R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca

The purpose of this study is to determine whether 0.2% and 0.5% R348 Ophthalmic Solutions are safe and effective in the treatment of Patients with Keratoconjunctivitis Sicca.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 204
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Artesia, California, United States, 90701
      • Sall Research Medical Center
    • Petaluma, California, United States, 94954
      • North Bay Eye
    • Rancho Cardova, California, United States, 95670
      • Martel Medical Eye Group
  • Colorado
    • Parker, Colorado, United States, 808134
      • Specialty Eye Care
  • Florida
    • Brandon, Florida, United States, 33603
      • International Research Center
    • Stuart, Florida, United States, 34994
      • East Florida Eye Institute
  • Georgia
    • Morrow, Georgia, United States, 30260
      • Clayton Eye Center
    • Roswell, Georgia, United States, 30076
      • Coastal Research Associates
  • Illinois
    • Chicago, Illinois, United States, 60634
      • Chicago Research Center
    • Hoffman Estates, Illinois, United States, 60169
      • Chicago Cornea Consultants
  • Kentucky
    • Lebanon, Kentucky, United States, 40033
      • Koffler Vision Group
    • Louisville, Kentucky, United States, 40217
      • Taustine Eye Center
  • Missouri
    • Washington, Missouri, United States, 63090
      • Comprehensive Eye Care, Ltd/Vision Research Institute, LLC
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Mundorf Eye Center
    • Charlotte, North Carolina, United States, 28210
      • Charlotte Eye Ear Nose and Throat Associates, PA
    • High Point, North Carolina, United States, 27262
      • Cornerstone Eyecare
  • Ohio
    • Cleveland, Ohio, United States, 44115
      • Abrams Eye Center
  • South Carolina
    • Mt. Pleasant, South Carolina, United States, 29464
      • Glaucoma Consultants and Center for Eye Research
  • Tennessee
    • Chattanooga, Tennessee, United States, 37411
      • Chattanooga Eye Institute
  • Texas
    • San Antonio, Texas, United States, 78209
      • Eye Clinics of South Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A history of dry eye (based on the date of initial dry eye symptoms)
• Use of over-the-counter (OTC) and/or prescription eye drops for dry eye symptoms
• Corneal fluorescein staining score of at least 2 in the inferior region

Exclusion Criteria:

• History of, or a concurrent clinically significant illness, medical condition (other than Keratoconjunctivitis Sicca or Sjögren's syndrome), or laboratory abnormality that, in the Investigator's opinion, could affect the conduct of the study.
• Use of ophthalmic cyclosporine within 45 days of Visit 1.
• Use of any topical ophthalmic steroid within 2 weeks of Visit 1.
• Have worn contact lenses or anticipate using contact lenses during the study.
• Have a condition or be in a situation that the Investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
• Have a history of alcohol or substance abuse that, in the judgment of the Investigator, may impair or risk the subject's full participation in the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: R348 Ophthalmic Solution, 0.2%	Drug: R348 Ophthalmic Solution, 0.2%; R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks.; Other Names: R932348
Active Comparator: R348 Ophthalmic Solution, 0.5%	Drug: R348 Ophthalmic Solution, 0.5%; R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks.; Other Names: R932348
Placebo Comparator: Placebo; Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.	Drug: Placebo; Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Corneal Fluorescein Staining of the Inferior Cornea Region.	Change from baseline (Visit 3) of inferior region CFS score at 12 weeks. Inferior region CFS score range 0-4, where '0' represents no fluorescein staining and '4' represents severe staining on the cornea.	Baseline to Week 12

Collaborators and Investigators

• Sponsor: Rigel Pharmaceuticals
• Investigators: Study Director: Daniel Magilavy, MD, Rigel Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: July 11, 2013
• First Submitted That Met QC Criteria: July 11, 2013
• First Posted (Estimate): July 16, 2013

Study Record Updates

• Last Update Posted (Estimate): October 3, 2016
• Last Update Submitted That Met QC Criteria: August 9, 2016
• Last Verified: August 1, 2016

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-932348-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No