Trials / Completed
CompletedNCT06538662
An Investigation of FID 123320 for the Reduction of Ocular Redness in Pediatric and Adult Populations
A Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group Efficacy and Safety Study of FID 123320 Ophthalmic Solution for the Reduction of Ocular Redness in Pediatric and Adult Populations
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 283 (actual)
- Sponsor
- Alcon Research · Industry
- Sex
- All
- Age
- 5 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the safety and efficacy of FID 123320 Ophthalmic Solution compared to Vehicle for relieving redness of the eye due to minor eye irritations in pediatric and adult populations.
Detailed description
This study will enroll 2 cohorts: An adult cohort (Subjects 18 years and older of age from any race and ethnicity) and a pediatric cohort (Subjects 5 - 17 years of age from any race and ethnicity). The study will consist of 6 scheduled visits for each cohort: Screening and/or Baseline visit (Day -7 to -1, Visit 1), Eligibility verification/Randomization/1st Treatment visit on Day 1 (Visit 2), 2-week follow-up visit on Day 14 (Visit 3), 4-week follow-up visit on Day 28 (Visit 4), 8-week follow-up/Treatment discontinuation visit on Day 56 (Visit 5), and 7-day follow-up after treatment discontinuation/Exit visit on Day 63 (Visit 6). The primary endpoint will be collected at Day 1 (Visit 2). The expected study duration for each subject is approximately 10 weeks with approximately 8 weeks (56 days) of investigational product (IP) exposure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FID 123320 Ophthalmic Solution | Investigational sterile aqueous solution |
| DRUG | Vehicle | FID 123320 Ophthalmic Solution inactive ingredients |
Timeline
- Start date
- 2024-10-07
- Primary completion
- 2025-01-27
- Completion
- 2025-04-03
- First posted
- 2024-08-06
- Last updated
- 2026-01-22
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06538662. Inclusion in this directory is not an endorsement.