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

Sponsor
Rigel Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01733992
Collaborator
(none)
36
Enrollment
1
Location
4
Arms
3
Duration (Months)
11.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: R348 Ophthalmic Solution, 0.2%
  • Drug: R348 Ophthalmic Solution, 0.5%
  • Drug: R348 Ophthalmic Solution, 1.0%
  • Drug: Placebo
 Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Nov 1, 2012
Actual Primary Completion Date :
Feb 1, 2013
Actual Study Completion Date :
Feb 1, 2013

Arms and Interventions

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: R348 Ophthalmic Solution, 0.5%
    R348 Ophthalmic Solution, 0.5%, single and multiple ascending dose
    Other Names:
  • R932348

    • Drug: Placebo
    Placebo, single and multiple ascending dose
    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: R348 Ophthalmic Solution, 1.0%
    R348 Ophthalmic Solution, 1.0%, single and multiple ascending dose
    Other Names:
  • R932348

    • Drug: Placebo
    Placebo, single and multiple ascending dose
    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

    Outcome Measures

    Primary Outcome Measures

    1. Change in corneal fluorescein staining [Baseline and Visits 4, 8 and 12]

    Secondary Outcome Measures

    1. Change in conjunctival lissamine green staining [Baseline and Visits 4, 8 and 12]

    Other Outcome Measures

    1. Change in Schirmer test [Baseline and Visits 4, 8 and 12]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Andover Eye Associates Andover Massachusetts United States 01810

    Sponsors and Collaborators

    • Rigel Pharmaceuticals

    Investigators

    • Principal Investigator: Gail Torkildsen, MD, Andover Eye Associates

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rigel Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT01733992
    Other Study ID Numbers:
    • C-932348-002
    First Posted:
    Nov 27, 2012
    Last Update Posted:
    Aug 4, 2014
    Last Verified:
    Jul 1, 2014
    Additional relevant MeSH terms:
    Keratoconjunctivitis
    Keratoconjunctivitis Sicca
    Dry Eye Syndromes
    Pharmaceutical Solutions
    Ophthalmic Solutions

    Study Results

    No Results Posted as of Aug 4, 2014