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To Assess the Safety and Efficacy of R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca

NCT01900249 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2016-10-03

Study results available
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Summary

The purpose of this study is to determine whether 0.2% and 0.5% R348 Ophthalmic Solutions are safe and effective in the treatment of Patients with Keratoconjunctivitis Sicca.

Conditions

  • Keratoconjunctivitis Sicca

Interventions

DRUG

R348 Ophthalmic Solution, 0.2%

R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks.

DRUG

R348 Ophthalmic Solution, 0.5%

R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks.

DRUG

Placebo

Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks.

Sponsors & Collaborators

  • Rigel Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Daniel Magilavy, MD · Rigel Pharmaceuticals,Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-07-31
Completion
2014-07-31

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 NCT01900249 on ClinicalTrials.gov