An Investigation of FID 123320 for the Reduction of Ocular Redness in Pediatric and Adult Populations
Ocular Redness · Eye Irritation
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Phase 3
- Age range
- 5 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 284 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
The purpose of this study is to assess the safety and efficacy of FID 123320 Ophthalmic Solution (Apraclonidine HCl 0.125%) compared to Vehicle for relieving redness of the eye due to minor eye irritations in pediatric and adult populations.
Read the full 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Double masked
Apraclonidine HCl 0.125% - 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).
Drug: Apraclonidine Hydrochloride Ophthalmic 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).
Drug: Vehicle
Apraclonidine HCl 0.125% - 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).
Drug: Apraclonidine Hydrochloride Ophthalmic 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).
Drug: Vehicle
Apraclonidine Hydrochloride Ophthalmic Solution DRUG
Investigational ophthalmic solution applied topically to the eye with a dropper bottle
Vehicle DRUG
Vehicle (inactive ingredients) applied topically to the eye with a dropper bottle
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 15 Minutes Post-Instillation on Day 1 - Adult Cohort
Time frame: Baseline (Day 1 pre-instillation); Minute 15 (Day 1 post-instillation)
Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). The change from baseline, calculated as post-instillation minus baseline scores, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint.
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 10 Hours (600 Minutes) Post-Instillation on Day 1 - Adult Cohort
Time frame: Baseline (Day 1 pre-instillation); Hour 10 (600 minutes) (Day 1 post-instillation)
Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). The change from baseline, calculated as post-instillation minus baseline scores, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint.
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 1 Hour (60 Minutes) Post-Instillation on Day 1 - Pediatric Cohort (12-17 Years)
Time frame: Baseline (Day 1 pre-instillation); Hour 1 (60 minutes) (Day 1 post-instillation)
Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). The change from baseline, calculated as post-instillation minus baseline scores, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint.
Secondary measures
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 1 Minute Post-Instillation on Day 1 - Adult Cohort
Time frame: Baseline (Day 1 pre-instillation); Minute 1 (Day 1 post-instillation)
Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). The change from baseline, calculated as post-instillation minus baseline scores, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint.
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 8 Hours (480 Minutes) Post-instillation on Day 1 - Adult Cohort
Time frame: Baseline (Day 1 pre-instillation); Hour 8 (480 minutes) (Day 1 post-instillation)
Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). The change from baseline, calculated as post-instillation minus baseline scores, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint.
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 12 Hours (720 Minutes) Post-Instillation on Day 1 - Adult Cohort
Time frame: Baseline (Day 1 pre-instillation); Hour 12 (720 minutes) (Day 1 post-instillation)
Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). The change from baseline, calculated as post-instillation minus baseline scores, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint.
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 30 Seconds Post-instillation on Day 1 (Visit 2) - Adult Cohort
Time frame: Baseline (Day 1 pre-instillation); Second 30 (Day 1 post-instillation)
Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). The change from baseline, calculated as post-instillation minus baseline scores, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint.
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 1 Minute Post-Instillation on Day 1 - Pediatric Cohort (12-17 Years)
Time frame: Baseline (Day 1 pre-instillation); Minute 1 (Day 1 post-instillation)
Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). The change from baseline, calculated as post-instillation minus baseline scores, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint.
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 8 Hours (480 Minutes) Post-Instillation on Day 1 - Pediatric Cohort (12-17 Years)
Time frame: Baseline (Day 1 pre-instillation); Hour 8 (480 minutes) (Day 1 post-instillation)
Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). The change from baseline, calculated as post-instillation minus baseline scores, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint.
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 30 Seconds Post-Instillation on Day 1 - Pediatric Cohort (12-17 Years)
Time frame: Baseline (Day 1 pre-instillation); Second 30 (Day 1 post-instillation)
Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). The change from baseline, calculated as post-instillation minus baseline scores, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (8)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
8 locations
Eye Research FoundationNewport Beach, California, United StatesStatus unknown
Vision InstituteColorado Springs, Colorado, United StatesStatus unknown
Butchertown Clinical TrialsLouisville, Kentucky, United StatesStatus unknown
Andover Eye AssociatesAndover, Massachusetts, United StatesStatus unknown
NC Eye Associates, OD, PLLCApex, North Carolina, United StatesStatus unknown
CORE, Inc.Shelby, North Carolina, United StatesStatus unknown
Total Eye Care PAMemphis, Tennessee, United StatesStatus unknown
Advancing Vision Research, LLCSmyrna, Tennessee, United StatesStatus unknown
Study team and timeline
- Lead sponsor
- Alcon Research
- Study start
- Oct 7, 2024 Actual
- Primary completion
- Jan 27, 2025 Actual
- Study completion
- Apr 3, 2025 Actual
- First posted
- Aug 6, 2024 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
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
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026