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

Primary Purpose

Keratoconjunctivitis Sicca

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution, 0.5%
R348 Ophthalmic Solution, 1.0%
Placebo
Sponsored by
Rigel Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconjunctivitis Sicca

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Andover Eye Associates

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

R348 Ophthalmic Solution, 0.2%

R348 Ophthalmic Solution, 0.5%

R348 Ophthalmic Solution, 1.0%

Placebo

Arm Description

R348 Ophthalmic Solution, 0.2%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day.

R348 Ophthalmic Solution, 0.5%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day.

R348 Ophthalmic Solution, 1.0%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day.

Placebo, single (1 day) or multiple ascending dose (13 days) followed by a single dose on the fourteenth day.

Outcomes

Primary Outcome Measures

Change in corneal fluorescein staining

Secondary Outcome Measures

Change in conjunctival lissamine green staining

Full Information

First Posted
November 21, 2012
Last Updated
July 31, 2014
Sponsor
Rigel Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01733992
Brief Title
A Safety, Tolerability and Pharmacokinetics Study of R932348 Eye Drops in Patients With Dry Eye Disease
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 Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rigel Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconjunctivitis Sicca

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
R348 Ophthalmic Solution, 0.2%
Arm Type
Active Comparator
Arm Description
R348 Ophthalmic Solution, 0.2%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day.
Arm Title
R348 Ophthalmic Solution, 0.5%
Arm Type
Active Comparator
Arm Description
R348 Ophthalmic Solution, 0.5%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day.
Arm Title
R348 Ophthalmic Solution, 1.0%
Arm Type
Active Comparator
Arm Description
R348 Ophthalmic Solution, 1.0%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, single (1 day) or multiple ascending dose (13 days) followed by a single dose on the fourteenth day.
Intervention Type
Drug
Intervention Name(s)
R348 Ophthalmic Solution, 0.2%
Other Intervention Name(s)
R932348
Intervention Description
R348 Ophthalmic Solution, 0.2% single and multiple ascending dose
Intervention Type
Drug
Intervention Name(s)
R348 Ophthalmic Solution, 0.5%
Other Intervention Name(s)
R932348
Intervention Description
R348 Ophthalmic Solution, 0.5%, single and multiple ascending dose
Intervention Type
Drug
Intervention Name(s)
R348 Ophthalmic Solution, 1.0%
Other Intervention Name(s)
R932348
Intervention Description
R348 Ophthalmic Solution, 1.0%, single and multiple ascending dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, single and multiple ascending dose
Primary Outcome Measure Information:
Title
Change in corneal fluorescein staining
Time Frame
Baseline and Visits 4, 8 and 12
Secondary Outcome Measure Information:
Title
Change in conjunctival lissamine green staining
Time Frame
Baseline and Visits 4, 8 and 12
Other Pre-specified Outcome Measures:
Title
Change in Schirmer test
Time Frame
Baseline and Visits 4, 8 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail Torkildsen, MD
Organizational Affiliation
Andover Eye Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Andover Eye Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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