A Safety, Tolerability and Pharmacokinetics Study of R932348 Eye Drops in Patients With Dry Eye Disease
NCT ID: NCT01733992
Last Updated: 2014-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2012-11-30
2013-02-28
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
TRIPLE
Study Groups
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R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution, 0.2%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day.
R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution, 0.2% single and multiple ascending dose
Placebo
Placebo, single and multiple ascending dose
R348 Ophthalmic Solution, 0.5%
R348 Ophthalmic Solution, 0.5%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day.
R348 Ophthalmic Solution, 0.5%
R348 Ophthalmic Solution, 0.5%, single and multiple ascending dose
Placebo
Placebo, single and multiple ascending dose
R348 Ophthalmic Solution, 1.0%
R348 Ophthalmic Solution, 1.0%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day.
R348 Ophthalmic Solution, 1.0%
R348 Ophthalmic Solution, 1.0%, single and multiple ascending dose
Placebo
Placebo, single and multiple ascending dose
Placebo
Placebo, single (1 day) or multiple ascending dose (13 days) followed by a single dose on the fourteenth day.
Placebo
Placebo, single and multiple ascending dose
Interventions
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R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution, 0.2% single and multiple ascending dose
R348 Ophthalmic Solution, 0.5%
R348 Ophthalmic Solution, 0.5%, single and multiple ascending dose
R348 Ophthalmic Solution, 1.0%
R348 Ophthalmic Solution, 1.0%, single and multiple ascending dose
Placebo
Placebo, single and multiple ascending dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A corrected visual acuity in both eyes of 20/40 or better.
* An intraocular pressure of \< 21 mm Hg with a difference between eyes of \< 6 mm Hg.
Exclusion Criteria
* History or evidence of blepharitis requiring the use of antibiotics or eye scrubs within 2 months prior to the first dosing day.
* History of herpes simplex keratitis at any time.
* Current ocular allergy symptoms.
* Recent use of eye medications such as steroids or cyclosporine
* Refractive eye surgery within 12 months of the first dosing day.
* Other eye surgeries within 4 months of the first dosing day.
* Current use of contact lenses or discontinuation of contact lens use within 2 weeks of the first dosing day.
* Receipt of any blood or blood products within 90 days prior to the first dosing day.
* Participation in any clinical study within 30 days prior to the first dosing day.
* History of disease, or currently have a significant illness or abnormal laboratory finding as determined by your study doctor.
* Positive for hepatitis B, hepatitis C or HIV.
* Smoked regularly within 12 months of first dosing day.
* History of substance abuse, drug addiction or alcoholism.
18 Years
80 Years
ALL
No
Sponsors
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Rigel Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Gail Torkildsen, MD
Role: PRINCIPAL_INVESTIGATOR
Andover Eye Associates
Locations
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Andover Eye Associates
Andover, Massachusetts, United States
Countries
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Other Identifiers
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C-932348-002
Identifier Type: -
Identifier Source: org_study_id
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