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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Toyos Clinic
• Collaborator: Sun Pharmaceutical Industries Limited
• Treatments: Cyclosporine; Cyclosporins; Lifitegrast

Criteria

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. -