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

Primary Purpose

Dry Eye

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

nanomicellular cyclosporine 0.09%

Lifitegrast

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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
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
Anticipated relocation or extensive travel during study period. -

Sites / Locations

Toyos ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nanomicellular Cyclosporine 0.09 prior to surgery

Lifitegrast 5.0%

Arm Description

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

50 subjects receive liftigrast 5.0% prior to elective ophthalmic surgery

Outcomes

Primary Outcome Measures

change in central corneal staining

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

Secondary Outcome Measures

change in OSDI questionnaire with additional questions of dysgeusia, blurriness and sensation of burning

subjective improvement of symptoms and assessment of adverse events

change in corneal topography

variation in measurements of corneal topography

change in Schirmers testing

Full Information

NCT ID

NCT04172961

First Posted

November 18, 2019

Last Updated

October 18, 2022

Sponsor

Toyos Clinic

Collaborators

Sun Pharmaceutical Industries Limited

1. Study Identification

Unique Protocol Identification Number

NCT04172961

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 1, 2020 (Actual)

Primary Completion Date

December 1, 2022 (Anticipated)

Study Completion Date

December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Toyos Clinic

Collaborators

Sun Pharmaceutical Industries Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

study medication will be provided in an unmarked box with tape externally covering any identifying language

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Nanomicellular Cyclosporine 0.09 prior to surgery

Arm Type

Experimental

Arm Description

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

Arm Title

Lifitegrast 5.0%

Arm Type

Active Comparator

Arm Description

50 subjects receive liftigrast 5.0% prior to elective ophthalmic surgery

Intervention Type

Drug

Intervention Name(s)

nanomicellular cyclosporine 0.09%

Other Intervention Name(s)

Cequa

Intervention Description

topical ophthalmic drop prior to elective surgery for eligible patients

Intervention Type

Drug

Intervention Name(s)

Lifitegrast

Other Intervention Name(s)

Xiidra

Intervention Description

topical ophthalmic drop prior to elective surgery for eligible patients

Primary Outcome Measure Information:

Title

change in central corneal staining

Description

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

Time Frame

90 days

Secondary Outcome Measure Information:

Title

change in OSDI questionnaire with additional questions of dysgeusia, blurriness and sensation of burning

Description

subjective improvement of symptoms and assessment of adverse events

Time Frame

90 days

Title

change in corneal topography

Description

variation in measurements of corneal topography

Time Frame

90 days

Title

change in Schirmers testing

Description

change in Schirmers testing

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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 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 Anticipated relocation or extensive travel during study period. -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rachel McQuiddy

Phone

6153274015

rmcquiddy@toyosclinic.com

First Name & Middle Initial & Last Name or Official Title & Degree

Melissa Toyos, MD

Phone

6153274015

mtoyos@toyosclinic.com

Facility Information:

Facility Name

Toyos Clinic

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37215

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rachel McQuiddy

Phone

615-327-4015

rmcquiddy@toyosclinic.com

First Name & Middle Initial & Last Name & Degree

Melissa Toyos, MD

Phone

6153274015

mtoyos@toyosclinic.com

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No plan to share individual date with other researchers

Learn more about this trial

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

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