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

NCT01733992 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2014-08-04

No results posted yet for this study

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

Interventions

DRUG

R348 Ophthalmic Solution, 0.2%

R348 Ophthalmic Solution, 0.2% single and multiple ascending dose

DRUG

R348 Ophthalmic Solution, 0.5%

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

DRUG

R348 Ophthalmic Solution, 1.0%

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

DRUG

Placebo

Placebo, single and multiple ascending dose

Sponsors & Collaborators

  • Rigel Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Gail Torkildsen, MD · Andover Eye Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01733992 on ClinicalTrials.gov