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
446
mi
from 43215
Morrow, GA
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Artesia, California 90701
1968
mi
from 43215
Artesia, CA
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Brandon, Florida 33603
828
mi
from 43215
Brandon, FL
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Charlotte, North Carolina 28210
354
mi
from 43215
Charlotte, NC
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Charlotte, North Carolina
348
mi
from 43215
Charlotte, NC
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Chattanooga, Tennessee 37411
355
mi
from 43215
Chattanooga, TN
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Chicago, Illinois 60634
284
mi
from 43215
Chicago, IL
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Cleveland, Ohio 44115
127
mi
from 43215
Cleveland, OH
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High Point, North Carolina 27262
320
mi
from 43215
High Point, NC
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Hoffman Estates, Illinois
302
mi
from 43215
Hoffman Estates, IL
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Lebanon, Kentucky 40033
204
mi
from 43215
Lebanon, KY
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Louisville, Kentucky 40217
189
mi
from 43215
Louisville, KY
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Mt. Pleasant, South Carolina 29464
523
mi
from 43215
Mt. Pleasant, SC
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Parker, Colorado 80813
1152
mi
from 43215
Parker, CO
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Petaluma, California 94954
2109
mi
from 43215
Petaluma, CA
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Rancho Cardova, California 95670
2033
mi
from 43215
Rancho Cardova, CA
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Roswell, Georgia 30076
417
mi
from 43215
Roswell, GA
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San Antonio, Texas 78209
1135
mi
from 43215
San Antonio, TX
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Stuart, Florida 34994
896
mi
from 43215
Stuart, FL
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438
mi
from 43215
Washington, MO
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