A Multicenter, Randomized, Vehicle-Controlled Evaluation of the Efficacy and Safety of FID 123472 Ophthalmic Solution for the Reduction of Ocular Redness in Adult Subjects
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 caused by minor eye irritations.
Description
Eligible subjects will be expected to attend a total of 6 in-office study visits over a period of approximately 10 weeks. Subjects will receive a single dose of study treatment in each eye (either Apraclonidine 0.125% UDPF or Vehicle) on Day 1, after which subjects will be instructed to self-administer one drop in each eye twice daily at home for a total of approximately 8 weeks (Days 2-55), with the last dose administered on Day 56 in office. Subjects will then return for the final study visit on Day 63, following a 1-week treatment discontinuation. Eye redness will be assessed before and aft…
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 ocular redness score greater than 1 unit on a 5-point scale in both eyes prior to randomization. * Other protocol-defined inclusion criteria may apply. Key Excl…
Interventions
- DrugApraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free
Investigational ophthalmic solution applied topically to the eye in a unit dose preservative free formulation
- DrugVehicle
Inactive ingredients of FID 123472 applied topically to the eye as an ophthalmic solution in a unit dose preservative free formulation
Location
- Contact Alcon Call Center for Trial LocationsFort Worth, Texas