Clinical trial NCT04172961: Clinical Efficacy of Two Topical Dry Eye Drops for Central Corneal Stain Clearing Over 90 Days
Official title: A Phase 4 Study to Assess the Clinical Efficacy of Nanomicellular Cyclosporine 0.09% Versus Lifitegrast 5.0% for Central Corneal Stain Clearing Over 90 Days
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dry Eye
Lead sponsor: Toyos Clinic
Sponsor class: OTHER
Collaborators: name: Sun Pharmaceutical Industries Limited
First posted: 2019-11-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be a randomized, double-blind prospective in 3 clinical sites to compare the efficacy of two currently approved topical ophthalmic drops in the clearing central corneal staining in 90 days prior to elective cataract or LASIK surgery.

Detailed description: The study will be a randomized, double-blind prospective study in 3 sites in the US to compare efficacy of improvement in central corneal staining with fluorescein dye evaluations at slit lamp exam, secondarily improvement in OSDI questionnaire with additional questions regarding dysgeusia, blurriness, and sensation of burning, improvements in corneal topography and improvements in Schirmer's testing. 100 study subjects 18-85 male or female will be enrolled in the Nashville, Beverly Hills and St. Louis areas who are generally healthy with central corneal staining and scheduled for uncomplicated phacoemulsification or uncomplicated LASIK.

Eligibility criteria: Inclusion Criteria:

1. Subject is able to read, understand and sign informed consent.
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.

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Exclusion Criteria:

1. Known hypersensitivity or contraindication to investigational product.
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. -

Primary outcomes:
measure: change in central corneal staining
timeFrame: 90 days
Secondary outcomes:
measure: change in OSDI questionnaire with additional questions of dysgeusia, blurriness and sensation of burning
timeFrame: 90 days
measure: change in corneal topography
timeFrame: 90 days
measure: change in Schirmers testing
timeFrame: 90 days
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Toyos Clinic
state: Tennessee
Study officials:
References: