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

NCT01733992 | Completed Phase 1

• 1 other identifier: C-932348-002
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Keratoconjunctivitis Sicca

Outcome Measures

Primary Outcomes (1)

• Change in corneal fluorescein staining

  Baseline and Visits 4, 8 and 12

Secondary Outcomes (1)

• Change in conjunctival lissamine green staining

  Baseline and Visits 4, 8 and 12

Other Outcomes (1)

• Change in Schirmer test

  Baseline and Visits 4, 8 and 12

Study Arms (4)

R348 Ophthalmic Solution, 0.2%

ACTIVE COMPARATOR

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%; Drug: Placebo

R348 Ophthalmic Solution, 0.5%

ACTIVE COMPARATOR

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%; Drug: Placebo

R348 Ophthalmic Solution, 1.0%

ACTIVE COMPARATOR

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%; Drug: Placebo

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

R348 Ophthalmic Solution, 0.2% DRUG

R348 Ophthalmic Solution, 0.2% single and multiple ascending dose

Also known as: R932348

R348 Ophthalmic Solution, 0.2%

R348 Ophthalmic Solution, 0.5% DRUG

R348 Ophthalmic Solution, 0.5%, single and multiple ascending dose

Also known as: R932348

R348 Ophthalmic Solution, 0.5%

R348 Ophthalmic Solution, 1.0% DRUG

R348 Ophthalmic Solution, 1.0%, single and multiple ascending dose

Also known as: R932348

R348 Ophthalmic Solution, 1.0%

Placebo DRUG

Placebo, single and multiple ascending dose

Placebo; R348 Ophthalmic Solution, 0.2%; R348 Ophthalmic Solution, 0.5%; R348 Ophthalmic Solution, 1.0%

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigel Pharmaceuticals: lead

Study Sites (1)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Keratoconjunctivitis Sicca

Condition Hierarchy (Ancestors)

Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases

Study Officials

• Gail Torkildsen, MD

  Andover Eye Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2012
• First Posted: November 27, 2012
• Study Start: November 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: August 4, 2014

Record last verified: 2014-07

Locations

US (1)