Status:
COMPLETED
An Investigation of FID 123320 for the Reduction of Ocular Redness in Pediatric and Adult Populations
Lead Sponsor:
Alcon Research
Conditions:
Ocular Redness
Eye Irritation
Eligibility:
All Genders
5+ years
Phase:
PHASE3
Brief 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 adul...
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). T...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria - Adult Cohort:
- Capable of giving signed informed consent;
- Willing and able to follow all instructions and attend all study visits;
- Able to self-administer eye drops in the opinion of the investigator;
- Have a history of vasoconstrictor (redness relief drop) use within the last 6 months, have an interest in using over-the-counter (OTC) vasoconstrictor eye drops for redness relief, or would benefit from the use of redness relief drops in the opinion of the investigator;
- Ocular health within normal limits, including distance best corrected visual acuity of 20/40 or better in each eye as measured using a Snellen chart;
- Stable ocular health (defined as no ocular conditions requiring therapy or surgical intervention) during the study;
- Other protocol-defined inclusion criteria may apply.
- Key Inclusion Criteria - Pediatric Cohort:
- All pediatric subjects: Parent or legal guardian signs informed consent;
- Pediatric subject ages 7-17: Sign an assent form;
- Subject and parent/legal guardian/care giver: Willing and able to follow all instructions and attend all study visits;
- Able to self-administer eye drops satisfactorily or have a subject's care provider or parent/legal guardian at home routinely available for this purpose;
- Ocular health within normal limits; best-corrected visual acuity of 20/40 or better in each eye as measured using a Snellen chart;
- Stable ocular health (defined as no ocular conditions requiring therapy or surgical intervention) during the study;
- Other protocol-specified inclusion criteria may apply.
- Key Exclusion Criteria - Pediatric and Adult Cohorts
- Known contraindications or sensitivity to the use of any of the investigational drug(s) or their components, or any other medication required by the protocol;
- Ocular surgical intervention within 6 months prior to Visit 1 (Day -7 to Day -1) or during the study;
- History of lid surgery;
- Ocular condition that, in the opinion of the investigator, could affect the subject's safety or study parameters;
- Other protocol-specified exclusion criteria may apply.
Exclusion
Key Trial Info
Start Date :
October 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2025
Estimated Enrollment :
283 Patients enrolled
Trial Details
Trial ID
NCT06538662
Start Date
October 7 2024
End Date
April 3 2025
Last Update
April 10 2025
Active Locations (10)
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1
Canyon City Eyecare
Azusa, California, United States, 91702
2
Eye Research Foundation
Newport Beach, California, United States, 92663
3
Vision Institute
Colorado Springs, Colorado, United States, 80907
4
Butchertown Clinical Trials
Louisville, Kentucky, United States, 40206