Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
325 participants
INTERVENTIONAL
2018-09-28
2020-03-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SDN-037
SDN-037
twice daily
vehicle
Placebo
twice daily
Interventions
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SDN-037
twice daily
Placebo
twice daily
Eligibility Criteria
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Inclusion Criteria
2. Be able and willing to follow study instructions and complete all required visits
3. Females of childbearing potential must not be pregnant (as confirmed by a negative urine pregnancy test
4. Able to self-instill the IP or have a caregiver available to instil all doses of the IP
Exclusion Criteria
2. An acute ocular infection (bacterial, viral or fungal) or active ocular inflammation in the study eye
3. Any active corneal pathology noted in the study eye
4. Currently suffering from alcohol and/or drug abuse
18 Years
ALL
No
Sponsors
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Sun Pharma Advanced Research Company Limited
INDUSTRY
Responsible Party
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Locations
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SPARC Site 13
Chandler, Arizona, United States
SPARC Site 14
Mesa, Arizona, United States
SPARC Site 11
Prescott, Arizona, United States
SPARC Site 12
Sun City, Arizona, United States
SPARC site 01
Fayetteville, Arkansas, United States
SPARC Site 10
Santa Barbara, California, United States
SPARC Site 08
Colorado Springs, Colorado, United States
SPARC Site 06
Coral Springs, Florida, United States
SPARC Site 18
Fort Myers, Florida, United States
SPARC Site 16
Jacksonville, Florida, United States
SPARC Site 07
Miami, Florida, United States
SPARC Site 15
Paducah, Kentucky, United States
SPARC Site 05
Saint Joseph, Michigan, United States
SPARC Site 09
Henderson, Nevada, United States
SPARC Site 03
Poughkeepsie, New York, United States
SPARC Site 04
Winston-Salem, North Carolina, United States
SPARC Site 17
Fargo, North Dakota, United States
SPARC Site 19
Austin, Texas, United States
SPARC Site 2
Mission, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CLR_16_31
Identifier Type: -
Identifier Source: org_study_id
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