A Safety Study of IVMED-85 Ophthalmic Solution in Healthy Adults

Official title

A Randomized, Vehicle-Controlled, Double-Masked Study of the Safety of IVMED-85 Ophthalmic Solution in Healthy Adults

Overview

The purpose of this trial is to determine the safety of IVMED-85 eye drops in healthy adult subjects. Participants will be assigned to either the active or vehicle eyedrop group. The participants will receive eye drops twice daily for 6 weeks. Participants will not know which eyedrop they are taking.

Detailed description

Randomized, double-masked, controlled studies are the gold standard of clinical research. This is a randomized, vehicle-controlled, double-masked Phase 1 clinical study to assess the safety of IVMED-85 ophthalmic solution in healthy adult subjects. 36 subjects (ages 18-49) will be randomly and equally assigned to one of two treatment groups: vehicle ophthalmic solution or 0.20 mg/mL IVMED-85 ophthalmic solution.

All subjects will dose twice daily (BID), morning and evening, in both eyes for 6 weeks. Subjects will attend 3 clinic visits (screening/baseline, Day 21, and Day 42 at which safety will be assessed. If any treatment-related adverse events occur, additional visits to monitor for resolution and/or treatment, at the Investigator's discretion, with at least 1 such visit occurring months 3 after the last study visit.

In this study, the vehicle is the control treatment, chosen to help ensure that any effect observed in the IVMED-85 group is due to the active ingredient. IVMED-85 will be administered as an eye drop, a common route of administration.

Interventions

• Drug IVMED-85 ophthalmic solution
  IVMED-85 ophthalmic solution (0.20 mg/mL), administer twice a day (morning and evening) in both eyes
• Drug Vehicle Ophthalmic Solution
  Vehicle ophthalmic solution, administer twice a day (morning and evening) in both eyes

Primary outcome measures

• Visual acuity [Time frame: From enrollment to the end of treatment at 6 weeks]
• Change in eye assessments [Time frame: From enrollment to the end of treatment at 6 weeks]
• Punctal stenosis or Bloody discharge [Time frame: From enrollment to the end of treatment at 6 weeks]
• Change in ocular assessments [Time frame: From enrollment to the end of treatment at 6 weeks]

Eligibility criteria

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.

• Age 18-49. -
• Ability to voluntarily provide written informed consent. -
• Being clinically healthy, as determined by the investigator. -
• Willing and able to comply with clinic visits and study-related procedures. -
• 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). -
• BCVA better than or equal to 0.2 logarithm of the minimum angle of resolution (logMAR) (20/30 Snellen equivalent). -
• Corneal thickness 450 to 670 μm. -
• Intraocular pressure (IOP) ≤22 mmHg. -
• Willingness to not wear mascara for 6 weeks of the study. -
• 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.

• 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. -
• Known copper allergy, sensitivity, or processing disorder (e.g., Wilson's disease). -
• Presence of significant central corneal scarring or hydrops. -
• History or presence of punctal stenosis or bloody discharge. -
• 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. -
• Previous cornea, glaucoma, eyelid, strabismus (exotropia or esotropia), or intraocular surgeries. -
• 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. -
• 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). -
• Active or recent (within 2 weeks prior to screening) bacterial, viral, or allergic conjunctivitis. -
• Active allergies causing uncontrolled ocular and nasal symptoms. -
• Active sinusitis. -
• Current or previous hypothyroidism or hyperthyroidism. -
• Ongoing or recent (within 3 months prior to screening) chronic use of eyedrops containing preservatives such as benzalkonium chloride (BAK), Purite, or Polyquad. -
• History of uncontrolled gastroenteric reflux disease or deviated nasal septum. -
• If a female of childbearing potential (FOCBP):

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Total Eye Care, P.A. — Memphis

Identifiers

NCT: NCT07370584 · IVNA 22-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗