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| Name | Class |
|---|---|
| Sun Pharmaceutical Industries Limited | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nanomicellular Cyclosporine 0.09 prior to surgery | Experimental | 50 subjects receive nanomicellular cyclosporien 0.09% prior to elective ophthalmic surgery |
|
| Lifitegrast 5.0% | Active Comparator | 50 subjects receive liftigrast 5.0% prior to elective ophthalmic surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nanomicellular cyclosporine 0.09% | Drug | topical ophthalmic drop prior to elective surgery for eligible patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in central corneal staining | use of fluorescein staining to count at slit lamp actual number of central cornea spk | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| change in OSDI questionnaire with additional questions of dysgeusia, blurriness and sensation of burning | subjective improvement of symptoms and assessment of adverse events | 90 days |
| change in corneal topography |
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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.
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel McQuiddy | Contact | 6153274015 | rmcquiddy@toyosclinic.com | |
| Melissa Toyos, MD | Contact | 6153274015 | mtoyos@toyosclinic.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toyos Clinic | Recruiting | Nashville | Tennessee | 37215 | United States |
No plan to share individual date with other researchers
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| C575157 | lifitegrast |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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study medication will be provided in an unmarked box with tape externally covering any identifying language
| Lifitegrast | Drug | topical ophthalmic drop prior to elective surgery for eligible patients |
|
|
variation in measurements of corneal topography
| 90 days |
| change in Schirmers testing | change in Schirmers testing | 90 days |
| D000602 |
| Amino Acids, Peptides, and Proteins |