A Randomized, Vehicle-Controlled, Double-Masked Study of the Safety of IVMED-85 Ophthalmic Solution in Healthy Adults
iVeena Delivery Systems, Inc.
Summary
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.
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 w…
Eligibility
- Age range
- 18–49 years
- Sex
- All
- Healthy volunteers
- Yes
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 admin…
Interventions
- DrugIVMED-85 ophthalmic solution
IVMED-85 ophthalmic solution (0.20 mg/mL), administer twice a day (morning and evening) in both eyes
- DrugVehicle Ophthalmic Solution
Vehicle ophthalmic solution, administer twice a day (morning and evening) in both eyes
Location
- Total Eye Care, P.A.Memphis, Tennessee