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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dry Eye
• Intervention / Treatment: Drug: nanomicellular cyclosporine 0.09%; Drug: Lifitegrast

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Rachel McQuiddy; Phone Number: 6153274015; Email: rmcquiddy@toyosclinic.com
• Study Contact Backup: Name: Melissa Toyos, MD; Phone Number: 6153274015; Email: mtoyos@toyosclinic.com

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Recruiting
      • Toyos Clinic
      • Contact: Melissa Toyos, MD; Phone Number: 6153274015; Email: mtoyos@toyosclinic.com
      • Contact: Rachel McQuiddy; Phone Number: 615-327-4015; Email: rmcquiddy@toyosclinic.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	variation in measurements of corneal topography	90 days
change in Schirmers testing	change in Schirmers testing	90 days

Collaborators and Investigators

• Sponsor: Toyos Clinic
• Collaborators: Sun Pharmaceutical Industries Limited

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: November 18, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 21, 2019

Study Record Updates

• Last Update Posted (Actual): October 20, 2022
• Last Update Submitted That Met QC Criteria: October 18, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Antifungal Agents; Pharmaceutical Solutions; Calcineurin Inhibitors; Ophthalmic Solutions; Cyclosporine; Cyclosporins; Lifitegrast
• Other Study ID Numbers: SUNTC-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plan to share individual date with other researchers

Drug and device information, study documents

• 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