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



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 85
Updated:5/5/2014
Start Date:July 2013
End Date:July 2014
Contact:Daniel Magilavy, MD
Email:DMagilavy@Rigel.com
Phone:650-624-1372

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A Phase 2, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of 0.2% and 0.5% R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca

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.


Inclusion Criteria:

- A history of dry eye (based on the date of initial dry eye symptoms)

- Use of over-the-counter (OTC) and/or prescription eye drops for dry eye symptoms

- Corneal fluorescein staining score of at least 2 in the inferior region

Exclusion Criteria:

- History of, or a concurrent clinically significant illness, medical condition (other
than Keratoconjunctivitis Sicca or Sjögren's syndrome), or laboratory abnormality
that, in the Investigator's opinion, could affect the conduct of the study.

- Use of ophthalmic cyclosporine within 45 days of Visit 1.

- Use of any topical ophthalmic steroid within 2 weeks of Visit 1.

- Have worn contact lenses or anticipate using contact lenses during the study.

- Have a condition or be in a situation that the Investigator feels may put the subject
at significant risk, may confound the study results, or may interfere significantly
with the subject's participation in the study.

- Have a history of alcohol or substance abuse that, in the judgment of the
Investigator, may impair or risk the subject's full participation in the study.
We found this trial at
20
sites
Morrow, Georgia 30260
808
mi
from
Morrow, GA
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Artesia, California 90701
1163
mi
from
Artesia, CA
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Brandon, Florida 33603
1115
mi
from
Brandon, FL
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Charlotte, North Carolina 28210
958
mi
from
Charlotte, NC
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Charlotte, North Carolina
958
mi
from
Charlotte, NC
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Chattanooga, Tennessee 37411
721
mi
from
Chattanooga, TN
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Chicago, Illinois 60634
605
mi
from
Chicago, IL
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Cleveland, Ohio 44115
895
mi
from
Cleveland, OH
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High Point, North Carolina 27262
989
mi
from
High Point, NC
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Hoffman Estates, Illinois
593
mi
from
Hoffman Estates, IL
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Lebanon, Kentucky 40033
687
mi
from
Lebanon, KY
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Louisville, Kentucky 40217
658
mi
from
Louisville, KY
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Mt. Pleasant, South Carolina 29464
1067
mi
from
Mt. Pleasant, SC
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Parker, Colorado 80813
393
mi
from
Parker, CO
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Petaluma, California 94954
1347
mi
from
Petaluma, CA
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Rancho Cardova, California 95670
1272
mi
from
Rancho Cardova, CA
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Roswell, Georgia 30076
795
mi
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Roswell, GA
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San Antonio, Texas 78209
572
mi
from
San Antonio, TX
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Stuart, Florida 34994
1253
mi
from
Stuart, FL
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374
mi
from
Washington, MO
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