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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FID 123320 Ophthalmic Solution - Adult Cohort | Experimental | 1 drop instilled in each eye at Visit 2 (Day 1), followed by one drop instilled in each eye twice a day (approximately 12 hours apart) Day 2 up to Visit 5 (Day 56), followed by 1 drop instilled in each eye at Visit 5 (Day 56). |
|
| Vehicle - Adult Cohort | Placebo Comparator | 1 drop instilled in each eye at Visit 2 (Day 1), followed by one drop instilled in each eye twice a day (approximately 12 hours apart) Day 2 up to Visit 5 (Day 56), followed by 1 drop instilled in each eye at Visit 5 (Day 56). |
|
| FID 123320 Ophthalmic Solution - Pediatric Cohort | Experimental | 1 drop instilled in each eye at Visit 2 (Day 1), followed by one drop instilled in each eye twice a day (approximately 12 hours apart) Day 2 up to Visit 5 (Day 56), followed by 1 drop instilled in each eye at Visit 5 (Day 56). |
|
| Vehicle - Pediatric Cohort | Placebo Comparator | 1 drop instilled in each eye at Visit 2 (Day 1), followed by one drop instilled in each eye twice a day (approximately 12 hours apart) Day 2 up to Visit 5 (Day 56), followed by 1 drop instilled in each eye at Visit 5 (Day 56). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FID 123320 Ophthalmic Solution | Drug | Investigational sterile aqueous solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1 (Visit 2) - Adult Cohort | Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale. This is a co-primary endpoint. | Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 15 minutes post-instillation |
| Mean change from baseline in investigator-assessed ocular redness at 10 hours (600 minutes) post-instillation on Day 1 (Visit 2) - Adult Cohort | Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale. This is a co-primary endpoint. | Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 10 hours (600 minutes) post-instillation |
| Mean change from baseline in investigator-assessed ocular redness at 1 hour (60 minutes) post-instillation on Day 1 (Visit 2) - Pediatric Cohort (12-17 years) | Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale. | Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 1 hour (60 minutes) post-instillation |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in the investigator-assessed ocular redness at 1 minute post-instillation on Day 1 (Visit 2) - Adult Cohort | Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale. | Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 1 minute post-instillation |
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Key Inclusion Criteria - Adult Cohort:
Key Inclusion Criteria - Pediatric Cohort:
Key Exclusion Criteria - Pediatric and Adult Cohorts
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| Name | Affiliation | Role |
|---|---|---|
| Sr. Clinical Trial Lead, Pharma | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canyon City Eyecare | Azusa | California | 91702 | United States | ||
| Eye Research Foundation |
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| Vehicle | Drug | FID 123320 Ophthalmic Solution inactive ingredients |
|
| Mean change from baseline in the investigator-assessed ocular redness at 8 hours (480 minutes) post-instillation on Day 1 (Visit 2) - Adult Cohort |
Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale. |
| Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 8 hours (480 minutes) post-instillation |
| Mean change from baseline in the investigator-assessed ocular redness at 12 hours (720 minutes) post-instillation on Day 1 (Visit 2) - Adult Cohort | Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale. | Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 12 hours (720 minutes) post-instillation |
| Mean change from baseline in the investigator-assessed ocular redness at 30 seconds post-instillation on Day 1 (Visit 2) - Adult Cohort | Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale. | Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 30 seconds post-instillation |
| Mean change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1 (Visit 2) - Pediatric Cohort | Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale. This endpoint is pre-specified for pediatric subjects in the age range of 12-17 years. | Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 1 minute post-instillation |
| Mean change from baseline in investigator-assessed ocular redness at 8 hours (480 minutes) post-instillation on Day 1 (Visit 2) - Pediatric Cohort | Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale. This endpoint is pre-specified for pediatric subjects in the age range of 12-17 years. | Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 8 hours (480 minutes) post-instillation |
| Mean change from baseline in investigator assessed ocular redness at 30 seconds post-instillation on Day 1 (Visit 2) - Pediatric Cohort | Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale. This endpoint is pre-specified for pediatric subjects in the age range of 12-17 years. | Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 30 seconds post-instillation |
| Newport Beach |
| California |
| 92663 |
| United States |
| Vision Institute | Colorado Springs | Colorado | 80907 | United States |
| Butchertown Clinical Trials | Louisville | Kentucky | 40206 | United States |
| Andover Eye Associates | Andover | Massachusetts | 01810 | United States |
| NC Eye Associates, OD, PLLC | Apex | North Carolina | 27502 | United States |
| CORE, Inc. | Shelby | North Carolina | 28150 | United States |
| Total Eye Care PA | Memphis | Tennessee | 38119 | United States |
| Advancing Vision Research, LLC | Smyrna | Tennessee | 37167 | United States |
| Alamo Pediatric Eye Center, PLLC | San Antonio | Texas | 78249 | United States |