Ocular HyperemiaPhase 3NCT07578363
An Investigation of FID 123472 Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness in Adults
A Phase 3 study testing Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free in people with Ocular Hyperemia, run by Alcon Research at 5 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of an investigational ophthalmic solution in adults with ocular redness caused by minor eye irritations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Hyperemia
- What is being tested?
- Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 178 participants
- Where
- 5 sitesUnited States
- Study dates
- 27 Sep 2026to Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 ocular redness score of 0.5 unit or higher in at least one eye at Visit 1 and greater than 1 unit on a 5-point scale in both eyes prior to randomization at Visit 2.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Known contraindications or sensitivity to the use of any of the study treatment(s) or their components, or any other medication required by the protocol.
- Ocular surgical interventions 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 parameters.
- Use of prohibited medications, devices, or treatments as specified in the 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Oculus Research, Inc.
Garner, North Carolina, 27529
- Recruiting
Piedmont Eye Center
Lynchburg, Virginia, 24501
- Recruiting
Total Eye Care PA
Memphis, Tennessee, 38119
- Not yet recruiting
Wyse Eyecare
Northbrook, Illinois, 60062
- Not yet recruiting
CORE, Inc.
Shelby, North Carolina, 28150
About this study
Official title: A Multicenter, Randomized, Vehicle-Controlled Evaluation of the Efficacy and Safety of FID 123472 Ophthalmic Solution for the Reduction of Ocular Redness in Adult Subjects
The purpose of this study is to evaluate the efficacy and safety of an investigational ophthalmic solution in adults with ocular redness caused by minor eye irritations.
Read the detailed description
Eligible subjects will be expected to attend a total of 6 in-office study visits over a period of approximately 10 weeks. Subjects will receive a single dose of study treatment in each eye (either Apraclonidine 0.125% UDPF or Vehicle) on Day 1, after which subjects will be instructed to self-administer one drop in each eye twice daily at home for a total of approximately 8 weeks (Days 2-55), with the last dose administered on Day 56 in office. Subjects will then return for the final study visit on Day 63, following a 1-week treatment discontinuation. Eye redness will be assessed before and after instillation at prespecified timepoints.
- Conditions
- Ocular Hyperemia
- Being tested
- Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free, Vehicle
- Keywords
- Ocular Redness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative FreeDrug
Also called FID 123472, Apraclonidine 0.125% UDPF
Investigational ophthalmic solution applied topically to the eye in a unit dose preservative free formulation
VehicleDrug
Inactive ingredients of FID 123472 applied topically to the eye as an ophthalmic solution in a unit dose preservative free formulation
| Study group | Role | What they receive |
|---|---|---|
| Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free | Experimental | One drop in each eye on Day 1, followed by one drop in each eye twice daily (approximately 12 hours apart, but not less than 11.5 hours apart) beginning the day following Day 1 up until the day prior to Day 56. On the day of Day 56, subjects will receive the last dose in-office. Receives: Drug: Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free |
| Vehicle | Placebo comparator | One drop in each eye on Day 1, followed by one drop in each eye twice daily (approximately 12 hours apart, but not less than 11.5 hours apart) beginning the day following Day 1 up until the day prior to Day 56. On the day of Day 56, subjects will receive the last dose in-office. Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on 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.
Measured: Baseline (Day 1 pretreatment); 15 minutes post-instillation (Day 1)
Change from baseline in investigator-assessed ocular redness at 600 minutes post-instillation on 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.
Measured: Baseline (Day 1 pretreatment); 600 minutes post-instillation (Day 1)
Secondary outcomes (4)
Change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on 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).
Measured: Baseline (Day 1 pretreatment); 1 minute post-instillation (Day 1)
Change from baseline in investigator-assessed ocular redness at 720 minutes post-instillation on 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).
Measured: Baseline (Day 1 pretreatment); 720 minutes post-instillation (Day 1)
Change from baseline in investigator-assessed ocular redness at 30 seconds post-instillation on 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).
Measured: Baseline (Day 1 pretreatment); 30 seconds post-instillation (Day 1)
Number of subjects who achieve prespecified improvements from baseline in investigator-assessed ocular redness score in both eyes at 30 seconds post-instillation on 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). The 30-second score will be compared to the baseline score. The number of subjects with improvements as prespecified in the protocol will be reported.
Measured: Baseline (Day 1 pretreatment); 30 seconds post-instillation (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start27 Sep 2026
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular HyperemiaStudies 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
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, Pharma, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578363
- Sponsor's protocol ID
- DEW261-C003
- Status last verified
- Oct 2026
- First submitted
- 5 May 2026
- Last updated
- 16 Oct 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 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Vehicle-Controlled Evaluation of the Efficacy and Safety of FID 123472 Ophthalmic Solution for the Reduction of Ocular Redness in Adult Subjects
- ClinicalTrials.gov ID
- NCT07578363
- Acronym / sponsor ID
- DEW261-C003
- Conditions
- Ocular Hyperemia
- Keywords
- Ocular Redness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 11 May 2026 (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 evaluate the efficacy and safety of an investigational ophthalmic solution in adults with ocular redness caused by minor eye irritations.
Detailed description
Eligible subjects will be expected to attend a total of 6 in-office study visits over a period of approximately 10 weeks. Subjects will receive a single dose of study treatment in each eye (either Apraclonidine 0.125% UDPF or Vehicle) on Day 1, after which subjects will be instructed to self-administer one drop in each eye twice daily at home for a total of approximately 8 weeks (Days 2-55), with the last dose administered on Day 56 in office. Subjects will then return for the final study visit on Day 63, following a 1-week treatment discontinuation. Eye redness will be assessed before and after instillation at prespecified timepoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free | Experimental | Drug: Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative FreeOne drop in each eye on Day 1, followed by one drop in each eye twice daily (approximately 12 hours apart, but not less than 11.5 hours apart) beginning the day following Day 1 up until the day prior to Day 56. On the day of Day 56, subjects will receive the last dose in-office. |
| Vehicle | Placebo comparator | Drug: VehicleOne drop in each eye on Day 1, followed by one drop in each eye twice daily (approximately 12 hours apart, but not less than 11.5 hours apart) beginning the day following Day 1 up until the day prior to Day 56. On the day of Day 56, subjects will receive the last dose in-office. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 ocular redness score of 0.5 unit or higher in at least one eye at Visit 1 and greater than 1 unit on a 5-point scale in both eyes prior to randomization at Visit 2.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (7 listed)
- Known contraindications or sensitivity to the use of any of the study treatment(s) or their components, or any other medication required by the protocol.
- Ocular surgical interventions 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 parameters.
- Use of prohibited medications, devices, or treatments as specified in the protocol.
- Out of range vital signs (blood pressure and/or pulse rate) as defined in the study protocol.
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 |
|---|---|---|
| Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative FreeAlso: FID 123472, Apraclonidine 0.125% UDPFInvestigational ophthalmic solution applied topically to the eye in a unit dose preservative free formulation | Drug | Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free |
| VehicleInactive ingredients of FID 123472 applied topically to the eye as an ophthalmic solution in a unit dose preservative free formulation | Drug | Vehicle |
Primary outcome
Change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1
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 600 minutes post-instillation on Day 1
Time frame: Baseline (Day 1 pretreatment); 600 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.
4 secondary outcomes
Change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1
Time frame: Baseline (Day 1 pretreatment); 1 minute post-instillation (Day 1)
Change from baseline in investigator-assessed ocular redness at 720 minutes post-instillation on Day 1
Time frame: Baseline (Day 1 pretreatment); 720 minutes post-instillation (Day 1)
Change from baseline in investigator-assessed ocular redness at 30 seconds post-instillation on Day 1
Time frame: Baseline (Day 1 pretreatment); 30 seconds post-instillation (Day 1)
Number of subjects who achieve prespecified improvements from baseline in investigator-assessed ocular redness score in both eyes at 30 seconds post-instillation on Day 1
Time frame: Baseline (Day 1 pretreatment); 30 seconds post-instillation (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- EducationalLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Ocular Hyperemia
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BL1107 Response and Intensity Guided Dosing for Hyperemia Resolution Trial
Dry Eye Disease
RecruitingPhase 4
Evaluating Injection With the Use of Brimonidine Tartrate Ophthalmic 0.025% on Patients Using Netarsudil 0.02%/Latanoprost 0.005% to Treat Glaucoma
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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.
Clinical Trial Lead, Pharma study director
Alcon Research, LLC
5 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 Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free in people with Ocular Hyperemia, run by Alcon Research at 5 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alcon Call Center (1-888-451-3937, alcon.medinfo@alcon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1 (time frame: Baseline (Day 1 pretreatment); 15 minutes post-instillation (Day 1)). The study lists 2 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 16 Oct 2026.