An Investigation of FID 123320 for the Reduction of Ocular Redness in Pediatric and Adult Populations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

283 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-07

Study Completion Date

2025-04-03

Brief Summary

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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.

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Detailed Description

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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

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Ocular Redness Eye Irritation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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FID 123320 Ophthalmic Solution - Adult Cohort

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).

Group Type EXPERIMENTAL

FID 123320 Ophthalmic Solution

Intervention Type DRUG

Investigational sterile aqueous solution

Vehicle - Adult Cohort

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).

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

FID 123320 Ophthalmic Solution inactive ingredients

FID 123320 Ophthalmic Solution - Pediatric Cohort

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).

Group Type EXPERIMENTAL

FID 123320 Ophthalmic Solution

Intervention Type DRUG

Investigational sterile aqueous solution

Vehicle - Pediatric Cohort

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).

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

FID 123320 Ophthalmic Solution inactive ingredients

Interventions

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FID 123320 Ophthalmic Solution

Investigational sterile aqueous solution

Intervention Type DRUG

Vehicle

FID 123320 Ophthalmic Solution inactive ingredients

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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;

* 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;

Exclusion Criteria

* 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;

Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No