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

Keratoconjunctivitis Sicca Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01733992
• Other study ID #: C-932348-002
• Status: Completed
• Phase: Phase 1
• First received: November 21, 2012
• Last updated: July 31, 2014
• Start date: November 2012
• Est. completion date: February 2013

Study information

• Verified date: July 2014
• Source: Rigel Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca

Intervention

Drug:
• R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution, 0.2% single and multiple ascending dose
• R348 Ophthalmic Solution, 0.5%
R348 Ophthalmic Solution, 0.5%, single and multiple ascending dose
• R348 Ophthalmic Solution, 1.0%
R348 Ophthalmic Solution, 1.0%, single and multiple ascending dose
• Placebo
Placebo, single and multiple ascending dose

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Rigel Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Schirmer test		Baseline and Visits 4, 8 and 12	Yes
Primary	Change in corneal fluorescein staining		Baseline and Visits 4, 8 and 12	Yes
Secondary	Change in conjunctival lissamine green staining		Baseline and Visits 4, 8 and 12	Yes