Clinical Efficacy of Two Topical Dry Eye Drops for Central Corneal Stain Clearing Over 90 Days
NCT ID: NCT04172961
Last Updated: 2022-10-20
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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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2020-02-01
2022-12-01
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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Nanomicellular Cyclosporine 0.09 prior to surgery
50 subjects receive nanomicellular cyclosporien 0.09% prior to elective ophthalmic surgery
nanomicellular cyclosporine 0.09%
topical ophthalmic drop prior to elective surgery for eligible patients
Lifitegrast 5.0%
50 subjects receive liftigrast 5.0% prior to elective ophthalmic surgery
Lifitegrast
topical ophthalmic drop prior to elective surgery for eligible patients
Interventions
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nanomicellular cyclosporine 0.09%
topical ophthalmic drop prior to elective surgery for eligible patients
Lifitegrast
topical ophthalmic drop prior to elective surgery for eligible patients
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Provision of signed and dated informed consent and HIPAA authorization .
3. Willingness to comply with study procedures and availabilty for duration of study.
4. Aged 18-85, male or female
5. Minimum of 5 central corneal superficial punctate keratitis spots.
6. Normal eyelid anatomy
7. highly effective contraception for at least 1 month prior to screening and agreement to use effective contraception during study participation and for an additional 4 weeks after study drug discontinuation.
8. Postmenopausal or surgical sterilization.
\-
Exclusion Criteria
2. Contact lens use within one month prior to screening
3. Unwilling to discontinue contact lens.
4. pregnancy or lactation.
5. topical or nasal vasoconstrictors within 14 days prior to screening or unable to refrain from same.
6. Ocular surgery or eyelid surgery within 6 months prior to screening
7. Subjects can be on the following medications if they have been on a stable dose for 12 weeks: loteprednol, tetracycline, omega 3, anticholinergics, anticonvulsants, antidepressants, retinoids, systemic immunosuppressives including oral steroids, non-steroidals, antihistamines, mast cell stabilizers, punctal plugs, corticotropin repository or glaucoma medications.
8. abstain from eyelast growth products containing prostaglandin
9. Must not have had penetrating intraocular surgery, refractive surgery, cornea transplant, eyelid surgery within 6 months prior to Visit 1
10. Febrile illness within 1 week
11. Treatment with another investigational drug or intervention within one month
12. History of herpetic keratitis.
13. Serious or severe disease or uncontrolled medical condition that in the judgment of the investigator could confound study study assessments or limit compliance.
14. Use of new prescription eyedrop within 90 days of screening.
15. Change in systemic medication within 90 days of screening
16. Anticipated relocation or extensive travel during study period. -
18 Years
85 Years
ALL
Yes
Sponsors
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Sun Pharmaceutical Industries Limited
INDUSTRY
Toyos Clinic
OTHER
Responsible Party
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Locations
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Toyos Clinic
Nashville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SUNTC-001
Identifier Type: -
Identifier Source: org_study_id
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