Clinical Efficacy of Two Topical Dry Eye Drops for Central Corneal Stain Clearing Over 90 Days

Sponsor
Toyos Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04172961
Collaborator
Sun Pharmaceutical Industries Limited (Industry)
100
1
2
34
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
study medication will be provided in an unmarked box with tape externally covering any identifying language
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Nanomicellular Cyclosporine 0.09 prior to surgery

50 subjects receive nanomicellular cyclosporien 0.09% prior to elective ophthalmic surgery

Drug: nanomicellular cyclosporine 0.09%
topical ophthalmic drop prior to elective surgery for eligible patients
Other Names:
  • Cequa
  • Active Comparator: Lifitegrast 5.0%

    50 subjects receive liftigrast 5.0% prior to elective ophthalmic surgery

    Drug: Lifitegrast
    topical ophthalmic drop prior to elective surgery for eligible patients
    Other Names:
  • Xiidra
  • Outcome Measures

    Primary Outcome Measures

    1. change in central corneal staining [90 days]

      use of fluorescein staining to count at slit lamp actual number of central cornea spk

    Secondary Outcome Measures

    1. change in OSDI questionnaire with additional questions of dysgeusia, blurriness and sensation of burning [90 days]

      subjective improvement of symptoms and assessment of adverse events

    2. change in corneal topography [90 days]

      variation in measurements of corneal topography

    3. change in Schirmers testing [90 days]

      change in Schirmers testing

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    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. -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Toyos Clinic Nashville Tennessee United States 37215

    Sponsors and Collaborators

    • Toyos Clinic
    • Sun Pharmaceutical Industries Limited

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Toyos Clinic
    ClinicalTrials.gov Identifier:
    NCT04172961
    Other Study ID Numbers:
    • SUNTC-001
    First Posted:
    Nov 21, 2019
    Last Update Posted:
    Oct 5, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 5, 2021