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
Overview
- Phase
- Phase 4
- Intervention
- nanomicellular cyclosporine 0.09%
- Conditions
- Dry Eye
- Sponsor
- Toyos Clinic
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- change in central corneal staining
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is able to read, understand and sign informed consent.
- •Provision of signed and dated informed consent and HIPAA authorization .
- •Willingness to comply with study procedures and availabilty for duration of study.
- •Aged 18-85, male or female
- •Minimum of 5 central corneal superficial punctate keratitis spots.
- •Normal eyelid anatomy
- •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.
- •Postmenopausal or surgical sterilization.
Exclusion Criteria
- •Known hypersensitivity or contraindication to investigational product.
- •Contact lens use within one month prior to screening
- •Unwilling to discontinue contact lens.
- •pregnancy or lactation.
- •topical or nasal vasoconstrictors within 14 days prior to screening or unable to refrain from same.
- •Ocular surgery or eyelid surgery within 6 months prior to screening
- •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.
- •abstain from eyelast growth products containing prostaglandin
- •Must not have had penetrating intraocular surgery, refractive surgery, cornea transplant, eyelid surgery within 6 months prior to Visit 1
- •Febrile illness within 1 week
Arms & Interventions
Nanomicellular Cyclosporine 0.09 prior to surgery
50 subjects receive nanomicellular cyclosporien 0.09% prior to elective ophthalmic surgery
Intervention: nanomicellular cyclosporine 0.09%
Lifitegrast 5.0%
50 subjects receive liftigrast 5.0% prior to elective ophthalmic surgery
Intervention: Lifitegrast
Outcomes
Primary Outcomes
change in central corneal staining
Time Frame: 90 days
use of fluorescein staining to count at slit lamp actual number of central cornea spk
Secondary Outcomes
- change in OSDI questionnaire with additional questions of dysgeusia, blurriness and sensation of burning(90 days)
- change in corneal topography(90 days)
- change in Schirmers testing(90 days)