Un estudio aleatorizado, controlado con vehículo y doble enmascarado sobre la seguridad de la solución oftálmica IVMED-85 en adultos sanos

Inclusion Criteria:

• Subjects who meet all the following inclusion criteria at Visit 1 will be eligible to enroll in the study. Ocular criteria apply to both eyes.

  1. Age 18-49. -
  2. Ability to voluntarily provide written informed consent. -
  3. Being clinically healthy, as determined by the investigator. -
  4. Willing and able to comply with clinic visits and study-related procedures. -
  5. Willing and able to discontinue use of topical ocular medications, unless approved by investigator. Note: Artificial tears are allowed but must not be used within 30 minutes before or after administration of the study investigational product (IP). -
  6. BCVA better than or equal to 0.2 logarithm of the minimum angle of resolution (logMAR) (20/30 Snellen equivalent). -
  7. Corneal thickness 450 to 670 μm. -
  8. Intraocular pressure (IOP) ≤22 mmHg. -
  9. Willingness to not wear mascara for 6 weeks of the study. -
  10. Willingness to not swim in an indoor pool for 6 weeks of the study. -

Exclusion Criteria:

Subjects who meet any of the following criteria at Visit 1 will not be eligible to enroll in the study. Ocular criteria apply to either eye.

1. Participation in a clinical trial with the use of any investigational drug or treatment within 30 days prior to Visit 1 and duration of the study. -

2. Known copper allergy, sensitivity, or processing disorder (e.g., Wilson's disease). -

3. Presence of significant central corneal scarring or hydrops. -

4. History or presence of punctal stenosis or bloody discharge. -

5. History of or presence of nasolacrimal duct occlusion, nasolacrimal system trauma, nasolacrimal or eyelid cancer, ectropion or entropion, dacryocystitis, dacryoadenitis, chronic conjunctivitis, recurrent subconjunctival hemorrhage, trichiasis, distichiasis, or uncontrolled dry eye. -

6. Previous cornea, glaucoma, eyelid, strabismus (exotropia or esotropia), or intraocular surgeries. -

7. Current or previous ocular disorder, including but not limited to: strabismus (exotropia or esotropia), amblyopia, glaucoma, macular degeneration, cataract, retinal detachment or nystagmus, or abnormality of the central cornea, lens, iris, ciliary body, or central retina. -

8. Presence of any medical condition predisposing the subject to craniofacial anomalies, degenerative myopia, or abnormal ocular refractive anatomy (e.g., osteogenesis imperfecta or Stickler, Down, Ehlers-Danlos, Donnai-Barrow, Treacher-Collins, or Apert/Crouzon/ Pfeiffer syndrome). -

9. Active or recent (within 2 weeks prior to screening) bacterial, viral, or allergic conjunctivitis. -

10. Active allergies causing uncontrolled ocular and nasal symptoms. -

11. Active sinusitis. -

12. Current or previous hypothyroidism or hyperthyroidism. -

13. Ongoing or recent (within 3 months prior to screening) chronic use of eyedrops containing preservatives such as benzalkonium chloride (BAK), Purite, or Polyquad. -

14. History of uncontrolled gastroenteric reflux disease or deviated nasal septum. -

15. If a female of childbearing potential (FOCBP):

    1. Are pregnant or lactating.
    2. Are unwilling to use an effective form of contraception (e.g., hormonal, oral, transdermal, implant, injection, or abstinence) for the duration of the study. -

16. A male subject with a partner who is a FOCBP unwilling to use an effective form of contraceptives (e.g., barrier, hormonal, oral, transdermal, implant, injection, or abstinence) for either themselves or their partner, as appropriate, for the duration of the study. -