Safety and Efficacy Study of R932348 Ophthalmic Solution in Chronic Ocular Graft Versus Host Disease Patients(DROPS-2)
NCT ID: NCT02040623
Last Updated: 2016-10-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
35 participants
INTERVENTIONAL
2014-03-31
2016-07-31
Brief Summary
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* To investigate the safety and tolerability of R348 Ophthalmic Solutions administered for 12 weeks to subjects.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day
R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day
R348 Ophthalmic Solution, 0.5%
R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day
R348 Ophthalmic Solution, 0.5%
R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day
Placebo
Placebo Ophthalmic Solution 2 drops per eye twice a day
Placebo Ophthalmic Solution
Placebo Ophthalmic Solution 2 drops per eye twice a day
Interventions
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R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day
R348 Ophthalmic Solution, 0.5%
R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day
Placebo Ophthalmic Solution
Placebo Ophthalmic Solution 2 drops per eye twice a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects with post Allogeneic hematologic stem cell transplantation onset or worsening of dry eye symptoms for at least 1 month prior.
* Use of over-the-counter and/or prescription eye drops for dry eye symptoms within 1 month.
* Corneal fluorescein staining score of ≥ 2 in 1 region and ≥ 1 in at least 1 other region.
* Total lissamine green conjunctival staining score (according to a modified National Eye Institute grading system) of ≥ 2.
Exclusion Criteria
* Used topical ophthalmic cyclosporine within 45 days.
* Used any topical ophthalmic steroid within 2 weeks.
* Used autologous serum eye drops within 2 weeks.
18 Years
85 Years
ALL
No
Sponsors
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Rigel Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Rigel Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR
Rigel Pharmaceuticals,Inc.
Locations
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U. Miami - Bascom Palmer Eye Institute
Plantation, Florida, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
Countries
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Other Identifiers
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C-932348-004
Identifier Type: -
Identifier Source: org_study_id
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