A Two-Arm Multicenter Clinical Trial to Investigate Efficacy and Safety of FID123472 Ophthalmic Solution Compared With Vehicle in Adult Subjects With Ocular Redness
Alcon Research
Summary
The purpose of this study is to evaluate the efficacy and safety of an investigational ophthalmic solution in adults with ocular redness due to minor eye irritations.
Description
Eligible subjects will be expected to attend a total of 3 in-office study visits over a period of approximately 1 week. Subjects will receive a single dose of the study treatment in each eye on Day 1 (Visit 2). Eye redness will be assessed before and after instillations at prespecified timepoints.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Capable of giving signed informed consent and comply with the requirements listed in the Informed Consent Form. * Willing and able to follow all instructions and attend all study visits. * History of redness relief eyedrop use within the last 6 months, or an interest in using over-the-counter redness relief drops, or would benefit from the use of redness relief drops in the investigator's opinion. * Baseline investigator-assessed ocular redness score of greater than 1 on a 5-point scale in both eyes prior to randomization on Day 1 (Visit 2). * Other protocol-defined…
Interventions
- DrugApraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free
Investigational ophthalmic solution applied topically to the eye in a unit dose preservative free (UDPF) formulation
- DrugVehicle
Inactive ingredients of FID 123472 applied topically to the eye as an ophthalmic solution in a unit dose preservative free (UDPF) formulation
Location
- Contact Alcon Call Center for Trial LocationsFort Worth, Texas