NCT07531043 · Alcon Research
Efficacy and Safety of FID 123472 Ophthalmic Solution for Ocular Redness in Adults
What this study is about
The purpose of this study is to evaluate the effectiveness and safety of an experimental ophthalmic solution in adults with ocular redness due to minor eye irritations.
View original scientific description
The purpose of this study is to evaluate the efficacy and safety of an investigational ophthalmic solution in adults with ocular redness due to minor eye irritations.
Interventions
DRUG
Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free
Investigational ophthalmic solution applied topically to the eye in a unit dose preservative free (UDPF) formulation
DRUG
Vehicle
Inactive ingredients of FID 123472 applied topically to the eye as an ophthalmic solution in a unit dose preservative free (UDPF) formulation
Primary outcome measures
Change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1 (Visit 2)
Time frame: Baseline (Day 1 pretreatment); 15 minutes post-instillation (Day 1)
Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges 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). Change from baseline, calculated as post-instillation minus baseline score, 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.
Change from baseline in investigator-assessed ocular redness at 840 minutes (14 hours) post-instillation on Day 2 (Visit 3)
Time frame: Baseline (Day 1 pretreatment); 840 minutes (14 hours) post-instillation (Day 2)
Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges 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). Change from baseline, calculated as post-instillation minus baseline score, 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Capable of giving signed informed consent and comply with the requirements listed in the Informed Consent Form.
- Willing and able to follow all instructions and attend all study visits.
- History of redness relief eyedrop use within the last 6 months, or an interest in using over-the-counter redness relief drops, or would benefit from the use of redness relief drops in the investigator's opinion.
- Baseline investigator-assessed ocular redness score of 0.5 or higher in at least one eye at Visit 1 when applicable and a score of greater than 1.0 in both eyes on a 5-point scale prior to randomization on Day 1 (Visit 2).
- Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
- Known contraindications or sensitivity to the use of any of the investigational product(s) or their components, or any other medication required by the protocol.
- Ocular surgical intervention within 6 months prior to Visit 1 or during the study.
- Any ocular condition that, in the opinion of the investigator, may compromise the subject's safety or study specific parameters.
- Use of any of the prohibited medications or devices as specified in the study protocol.
- Out-of-range vital signs (blood pressure and/or pulse rate) as defined in the study protocol.
- Abnormal intraocular pressure.
- Other protocol-defined exclusion criteria may apply.
Where
- Los Angeles, California
- Newport Beach, California
- Pittsburg, Kansas
- Louisville, Kentucky
- Andover, Massachusetts
- Apex, North Carolina
- Cranberry Township, Pennsylvania
- Smyrna, Tennessee
- Fort Worth, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 16, 2026 · Source of record for eligibility and locations