RHA® Redensity Eye Versus No-treatment for the Infra-Orbital Hollows

Phase 1a: Subjects who will be randomly assigned to the RHA® Redensity Eye group at Screening will receive their injection at Visit 1. Subjects will come to the site 12 weeks (primary endpoint) after the initial treatment. Afterwards, subjects will proceed directly to Phase 2. Subjects randomly assigned to the No-treatment control group at Screening will receive no treatment in Phase 1a of the study. They will come to the site 12 weeks (primary endpoint) after randomization. After completing all assessments, subjects will immediately begin Phase 1b (Visit 1b is on the same day as Visit at Week 12) and will receive their initial treatment with RHA® Redensity Eye. Phase 1b: Phase 1b is only applicable to subjects initially randomly assigned to the No-treatment control group. Once all evaluations applicable for Visit at Week 12 are completed, subjects will proceed directly to Visit 1b (on the same day). Evaluations completed at Week 12 will be used for Visit 1b and will become the new Baseline for Phase 1b. Subjects will receive their initial treatment with RHA® Redensity Eye at Visit 1b. Subjects will follow the same schedule as those initially randomly assigned to the RHA® Redensity Eye group: RHA® Redensity Eye will be administered on the same day (Visit 1b). Subjects will come to the site 12 weeks after their initial treatment. Afterwards, subjects will proceed to Phase 2. Phase 2 and Exit visit: Phase 2 will occur 12 weeks after receiving initial treatment with RHA® Redensity Eye for subjects in the RHA® Redensity Eye group and the No-treatment control group (after Phase 1b). All these subjects will come to the site 24 weeks, and 52 weeks after their initial treatment. All subjects will be followed for 52 weeks after their initial treatment with RHA® Redensity Eye. Subjects will be offered retreatment (52 weeks after their initial treatment). Retreatment will be administered if the TI deems it to be appropriate and the subject agrees. If the subject does not receive retreatment, Visit at 52 weeks after initial treatment will become the Exit visit. If the subject receives retreatment, the subjects will come to the site 12 weeks after retreatment for follow-up and safety assessments. This will be the Exit visit.