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

NCT04172961 | Unknown Phase 4 FDA Drug

• 1 other identifier: SUNTC-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• change in central corneal staining

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

  90 days

Secondary Outcomes (3)

• 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

Study Arms (2)

Nanomicellular Cyclosporine 0.09 prior to surgery

EXPERIMENTAL

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

Drug: nanomicellular cyclosporine 0.09%

Lifitegrast 5.0%

ACTIVE COMPARATOR

50 subjects receive liftigrast 5.0% prior to elective ophthalmic surgery

Drug: Lifitegrast

Interventions

nanomicellular cyclosporine 0.09% DRUG

topical ophthalmic drop prior to elective surgery for eligible patients

Also known as: Cequa

Nanomicellular Cyclosporine 0.09 prior to surgery

Lifitegrast DRUG

topical ophthalmic drop prior to elective surgery for eligible patients

Also known as: Xiidra

Lifitegrast 5.0%

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Treatment with another investigational drug or intervention within one month
• History of herpetic keratitis.
• Serious or severe disease or uncontrolled medical condition that in the judgment of the investigator could confound study study assessments or limit compliance.
• Use of new prescription eyedrop within 90 days of screening.
• Change in systemic medication within 90 days of screening

Sponsors & Collaborators

• Toyos Clinic: lead
• Sun Pharmaceutical Industries Limited: collaborator

Study Sites (1)

Toyos Clinic

Nashville, Tennessee, 37215, United States

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Cyclosporins; lifitegrast

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Rachel McQuiddy

CONTACT

6153274015; rmcquiddy@toyosclinic.com

Melissa Toyos, MD

CONTACT

6153274015; mtoyos@toyosclinic.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: study medication will be provided in an unmarked box with tape externally covering any identifying language
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 21, 2019
• Study Start: February 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)