Ocular RednessPhase 3NCT06538662
An Investigation of FID 123320 for the Reduction of Ocular Redness in Pediatric and Adult Populations
A Phase 3 study testing FID 123320 Ophthalmic Solution in people with Ocular Redness and Eye Irritation, run by Alcon Research at 10 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Ocular Redness, Eye Irritation
- What is being tested?
- FID 123320 Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 283 participants
- Where
- 10 sitesUnited States
- Study dates
- 7 Oct 2024to 3 Apr 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
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- Other protocol-defined inclusion criteria may apply.
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Andover Eye Associates
Andover, Massachusetts, 01810
NC Eye Associates, OD, PLLC
Apex, North Carolina, 27502
Canyon City Eyecare
Azusa, California, 91702
Vision Institute
Colorado Springs, Colorado, 80907
Butchertown Clinical Trials
Louisville, Kentucky, 40206
Total Eye Care PA
Memphis, Tennessee, 38119
Eye Research Foundation
Newport Beach, California, 92663
Alamo Pediatric Eye Center, PLLC
San Antonio, Texas, 78249
CORE, Inc.
Shelby, North Carolina, 28150
Advancing Vision Research, LLC
Smyrna, Tennessee, 37167
About this study
Official 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
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.
Read the detailed 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.
- Conditions
- Ocular Redness, Eye Irritation
- Being tested
- FID 123320 Ophthalmic Solution, Vehicle
- Keywords
- Reduction of ocular redness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FID 123320 Ophthalmic SolutionDrug
Investigational sterile aqueous solution
VehicleDrug
FID 123320 Ophthalmic Solution inactive ingredients
| Study group | Role | What they receive |
|---|---|---|
| FID 123320 Ophthalmic Solution - Adult Cohort | Experimental | 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). Receives: Drug: FID 123320 Ophthalmic Solution |
| Vehicle - Adult Cohort | Placebo comparator | 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). Receives: Drug: Vehicle |
| FID 123320 Ophthalmic Solution - Pediatric Cohort | Experimental | 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). Receives: Drug: FID 123320 Ophthalmic Solution |
| Vehicle - Pediatric Cohort | Placebo comparator | 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). Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1 (Visit 2) - Adult Cohort
Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale. This is a co-primary endpoint.
Measured: Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 15 minutes post-instillation
Mean change from baseline in investigator-assessed ocular redness at 10 hours (600 minutes) post-instillation on Day 1 (Visit 2) - Adult Cohort
Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale. This is a co-primary endpoint.
Measured: Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 10 hours (600 minutes) post-instillation
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)
Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale.
Measured: Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 1 hour (60 minutes) post-instillation
Secondary outcomes (7)
Mean change from baseline in the investigator-assessed ocular redness at 1 minute post-instillation on Day 1 (Visit 2) - Adult Cohort
Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale.
Measured: 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
Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale.
Measured: 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
Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale.
Measured: Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 12 hours (720 minutes) post-instillation
Mean change from baseline in the investigator-assessed ocular redness at 30 seconds post-instillation on Day 1 (Visit 2) - Adult Cohort
Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale.
Measured: Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 30 seconds post-instillation
Mean change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1 (Visit 2) - Pediatric Cohort
Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale. This endpoint is pre-specified for pediatric subjects in the age range of 12-17 years.
Measured: Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 1 minute post-instillation
Mean change from baseline in investigator-assessed ocular redness at 8 hours (480 minutes) post-instillation on Day 1 (Visit 2) - Pediatric Cohort
Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale. This endpoint is pre-specified for pediatric subjects in the age range of 12-17 years.
Measured: Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 8 hours (480 minutes) post-instillation
Mean change from baseline in investigator assessed ocular redness at 30 seconds post-instillation on Day 1 (Visit 2) - Pediatric Cohort
Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale. This endpoint is pre-specified for pediatric subjects in the age range of 12-17 years.
Measured: Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 30 seconds post-instillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start7 Oct 2024
- Primary completion27 Jan 2025
- Study completion3 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular RednessStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sr. Clinical Trial Lead, Pharma, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538662
- Sponsor's protocol ID
- DEW422-C003
- Status last verified
- Jan 2026
- First submitted
- 2 Aug 2024
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06538662
- Acronym / sponsor ID
- DEW422-C003
- Conditions
- Ocular Redness, Eye Irritation
- Keywords
- Reduction of ocular redness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 27 Jan 2025 (actual)
- Study completion
- 3 Apr 2025 (actual)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FID 123320 Ophthalmic Solution - Adult Cohort | Experimental | Drug: FID 123320 Ophthalmic Solution1 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 Cohort | Placebo comparator | Drug: Vehicle1 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 Cohort | Experimental | Drug: FID 123320 Ophthalmic Solution1 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 Cohort | Placebo comparator | Drug: Vehicle1 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). |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FID 123320 Ophthalmic SolutionInvestigational sterile aqueous solution | Drug | FID 123320 Ophthalmic Solution - Adult Cohort, FID 123320 Ophthalmic Solution - Pediatric Cohort |
| VehicleFID 123320 Ophthalmic Solution inactive ingredients | Drug | Vehicle - Adult Cohort, Vehicle - Pediatric Cohort |
Primary outcome
Mean change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1 (Visit 2) - Adult Cohort
Time frame: 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
Time frame: 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)
Time frame: 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.
7 secondary outcomes
Mean change from baseline in the investigator-assessed ocular redness at 1 minute post-instillation on Day 1 (Visit 2) - Adult Cohort
Time frame: 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
Time frame: 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
Time frame: Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 12 hours (720 minutes) post-instillation
Mean change from baseline in the investigator-assessed ocular redness at 30 seconds post-instillation on Day 1 (Visit 2) - Adult Cohort
Time frame: Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 30 seconds post-instillation
Mean change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1 (Visit 2) - Pediatric Cohort
Time frame: Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 1 minute post-instillation
Mean change from baseline in investigator-assessed ocular redness at 8 hours (480 minutes) post-instillation on Day 1 (Visit 2) - Pediatric Cohort
Time frame: Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 8 hours (480 minutes) post-instillation
Mean change from baseline in investigator assessed ocular redness at 30 seconds post-instillation on Day 1 (Visit 2) - Pediatric Cohort
Time frame: Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 30 seconds post-instillation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sr. Clinical Trial Lead, Pharma study director
Alcon Research, LLC
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FID 123320 Ophthalmic Solution in people with Ocular Redness and Eye Irritation, run by Alcon Research at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1 (Visit 2) - Adult Cohort (time frame: Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 15 minutes post-instillation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.