Efficacy and Safety of FID 123472 Ophth… | Clinical Trial

Key information

Conditions

Ocular Hyperemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

About this study

Eligible subjects will be expected to attend a total of 3 in-office study visits over a period of approximately 1 week. Subjects will receive a single dose of the study treatment in each eye on Day 1 (Visit 2). Eye redness will be assessed before and after instillations at prespecified timepoints.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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 greater than 1 on a 5-point scale in both eyes 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.

Treatment and study plan

Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free

Drug

Investigational ophthalmic solution applied topically to the eye in a unit dose preservative free (UDPF) formulation

Other names: FID 123472, Apraclonidine 0.125% UDPF

Vehicle

Drug

Inactive ingredients of FID 123472 applied topically to the eye as an ophthalmic solution in a unit dose preservative free (UDPF) formulation

Primary outcomes

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.

Secondary outcomes

Change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1 (Visit 2)

Time frame: Baseline (Day 1 pretreatment); 1 minute 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).
Change from baseline in investigator-assessed ocular redness at 960 minutes (16 hours) post-instillation on Day 2 (Visit 3)

Time frame: Baseline (Day 1 pretreatment); 960 minutes (16 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Alcon Call Center

CONTACT

[email protected]

1-888-451-3937

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

A Two-Arm Multicenter Clinical Trial to Investigate Efficacy and Safety of FID123472 Ophthalmic Solution Compared With Vehicle in Adult Subjects With Ocular Redness

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Apr 15, 2026
Registry last updated: Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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