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FID 123320

Phase 3

Ocular Redness | Small molecule | Ophthalmology |Alcon Inc.|Trials Updated: Jan 22, 2026

FID 123320 development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Jun 2024

FID 123320 target and mechanism

ModalitySmall molecule

Also known as FID 123320 Ophthalmic Solution, Apraclonidine Hydrochloride Ophthalmic Solution

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment283

FDA Designations

No designations recorded

FID 123320 clinical trials

FID 123320 · 1 trial · 2 indications

Phase 3 1
NCT06538662An Investigation of FID 123320 for the Reduction of Ocular Redness in Pediatric and Adult PopulationsOcular Redness
COMPLETED283 Analytics
PHASE3COMPLETED
An Investigation of FID 123320 for the Reduction of Ocular Redness in Pediatric and Adult Populations
Ocular RednessUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1 (Visit 2) - Adult Cohort
Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 15 minutes post-instillation

Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale. This is a co-primary endpoint.

Mean change from baseline in investigator-assessed ocular redness at 10 hours (600 minutes) post-instillation on Day 1 (Visit 2) - Adult Cohort
Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 10 hours (600 minutes) post-instillation

Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale. This is a co-primary endpoint.

Mean change from baseline in investigator-assessed ocular redness at 1 hour (60 minutes) post-instillation on Day 1 (Visit 2) - Pediatric Cohort (12-17 years)
Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 1 hour (60 minutes) post-instillation

Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale.

Secondary Endpoints

Mean change from baseline in the investigator-assessed ocular redness at 1 minute post-instillation on Day 1 (Visit 2) - Adult Cohort
Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 1 minute post-instillation
Mean change from baseline in the investigator-assessed ocular redness at 8 hours (480 minutes) post-instillation on Day 1 (Visit 2) - Adult Cohort
Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 8 hours (480 minutes) post-instillation
Mean change from baseline in the investigator-assessed ocular redness at 12 hours (720 minutes) post-instillation on Day 1 (Visit 2) - Adult Cohort
Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 12 hours (720 minutes) post-instillation
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
FID 123320 Ophthalmic Solution - Adult CohortEXPERIMENTAL1 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).
Vehicle - Adult CohortPLACEBO_COMPARATOR1 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).
FID 123320 Ophthalmic Solution - Pediatric CohortEXPERIMENTAL1 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).
Vehicle - Pediatric CohortPLACEBO_COMPARATOR1 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).

Interventions

NameTypeDescription
FID 123320 Ophthalmic SolutionDRUGInvestigational sterile aqueous solution
VehicleDRUGFID 123320 Ophthalmic Solution inactive ingredients
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Eligibility Criteria

Age Range5 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

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...

Countries:United States
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Frequently asked questions about FID 123320

What is FID 123320?

FID 123320 is an investigational small molecule developed by Alcon Inc. (ticker ALC) as an ophthalmic solution for reducing ocular redness. It is being studied in a Phase 3 clinical program and is not yet approved. The completed trial enrolled 283 participants, including pediatric and adult populations.

What is FID 123320 used for?

FID 123320 is being developed to reduce ocular redness, also described as eye irritation. Alcon Inc. is studying the ophthalmic solution in both pediatric and adult populations. The Phase 3 trial listed ocular redness and eye irritation as the conditions under investigation.

Who makes FID 123320?

FID 123320 is developed by Alcon Inc., which trades under the ticker ALC. Alcon is an ophthalmology-focused company, and FID 123320 is its investigational ophthalmic solution for ocular redness. The program has completed one Phase 3 trial in the United States.

What phase is FID 123320 in?

FID 123320 is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The study was randomized, double-blind, and placebo-controlled, enrolling 283 participants. FID 123320 remains investigational and has not been approved for marketing.

What clinical trials is FID 123320 in?

FID 123320 has been studied in the Phase 3 trial NCT06538662, titled an investigation of FID 123320 for the reduction of ocular redness in pediatric and adult populations. The trial is completed, enrolled 283 participants, and was conducted in the United States. It included participants aged 5 years and older.

Is FID 123320 the same as FID 123320 Ophthalmic Solution?

Yes, FID 123320 Ophthalmic Solution is another name for FID 123320. Both refer to the same investigational small molecule from Alcon Inc. that is being developed in a topical ophthalmic formulation for reducing ocular redness.