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

Rigel Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Keratoconjunctivitis Sicca

Treatments: Drug: Placebo; Drug: R348 Ophthalmic Solution, 1.0%; Drug: R348 Ophthalmic Solution, 0.2%; Drug: R348 Ophthalmic Solution, 0.5%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01733992

C-932348-002

Details and patient eligibility

About

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

Full 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).

Enrollment: 36 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 4 patient groups, including a placebo group

R348 Ophthalmic Solution, 0.2%

Active Comparator group

Description:

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

Treatment:

Drug: R348 Ophthalmic Solution, 0.2%

Drug: Placebo

R348 Ophthalmic Solution, 0.5%

Active Comparator group

Description:

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

Treatment:

Drug: R348 Ophthalmic Solution, 0.5%

Drug: Placebo

R348 Ophthalmic Solution, 1.0%

Active Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: R348 Ophthalmic Solution, 1.0%

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo