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

Dry Eye Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04172961
• Other study ID #: SUNTC-001
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: October 2022
• Source: Toyos Clinic
• Contact: Rachel McQuiddy
• Phone: 6153274015
• Email: rmcquiddy[@]toyosclinic.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• nanomicellular cyclosporine 0.09%
topical ophthalmic drop prior to elective surgery for eligible patients
• Lifitegrast
topical ophthalmic drop prior to elective surgery for eligible patients

Locations

Country	Name	City	State
United States	Toyos Clinic	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Toyos Clinic	Sun Pharmaceutical Industries Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in central corneal staining	use of fluorescein staining to count at slit lamp actual number of central cornea spk	90 days
Secondary	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
Secondary	change in corneal topography	variation in measurements of corneal topography	90 days
Secondary	change in Schirmers testing	change in Schirmers testing	90 days