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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rigel Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01733992
First received: November 21, 2012
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Keratoconjunctivitis Sicca
Drug: R348 Ophthalmic Solution, 0.2%
Drug: R348 Ophthalmic Solution, 0.5%
Drug: R348 Ophthalmic Solution, 1.0%
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Rigel Pharmaceuticals:

Primary Outcome Measures:
  • Change in corneal fluorescein staining [ Time Frame: Baseline and Visits 4, 8 and 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in conjunctival lissamine green staining [ Time Frame: Baseline and Visits 4, 8 and 12 ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Change in Schirmer test [ Time Frame: Baseline and Visits 4, 8 and 12 ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: November 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01733992

Locations
United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Rigel Pharmaceuticals
Investigators
Principal Investigator: Gail Torkildsen, MD Andover Eye Associates
  More Information

No publications provided

Responsible Party: Rigel Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01733992     History of Changes
Other Study ID Numbers: C-932348-002
Study First Received: November 21, 2012
Last Updated: July 31, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis
Keratoconjunctivitis Sicca
Conjunctival Diseases
Conjunctivitis
Corneal Diseases
Eye Diseases
Keratitis
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014