Ocular RednessPhase 3NCT06444529
A Double-Masked Comparison of FID 123320 Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness
A Phase 3 study testing Apraclonidine Hydrochloride Ophthalmic Solution in people with Ocular Redness, run by Alcon Research at 5 sites in United States.
Trial summary
The purpose of this study is to assess the safety and efficacy of Apraclonidine Hydrochloride Ophthalmic Solution 0.125% when compared to Vehicle, in relieving redness of the eye due to minor eye irritations. This study will be conducted in the United States. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Redness
- What is being tested?
- Apraclonidine Hydrochloride Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 5 sitesUnited States
- Study dates
- 21 Aug 2024to 8 Jan 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 18 years and older
- All sexes
- No healthy volunteers
- 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;
- History of redness relief drop use within the last 6 months, or a desire to use over-the-counter (OTC) eye drops for redness relief;
- Females capable of becoming pregnant: Agree to urine pregnancy tests and the use of medically acceptable forms of birth control throughout the study;
- Ocular health within normal limits, including best-corrected visual acuity (BCVA) of 20/40 or better in each eye as measured using a Snellen chart;
- Ocular redness at baseline as specified in the protocol;
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Known contraindications or sensitivities to the use of any of the investigational drug(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;
- Ocular conditions that, in the opinion of the investigator, could affect the subject's safety or study parameters (i.e., could affect ocular redness, intraocular pressure, or eyelid position);
- Disallowed medications or devices as specified in the protocol;
- Planned surgery (ocular or systemic) during the study period or within 30 days after the study period;
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 16066
Emerson Clinical Research Institute, Inc.
Falls Church, Virginia, 22046
Oculus Research, Inc.
Garner, North Carolina, 27529
Global Research Management
Glendale, California, 91204
Piedmont Eye Center
Lynchburg, Virginia, 24502
About this study
Official title: A Double-Masked Comparison of Apraclonidine Hydrochloride Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness
The purpose of this study is to assess the safety and efficacy of Apraclonidine Hydrochloride Ophthalmic Solution 0.125% when compared to Vehicle, in relieving redness of the eye due to minor eye irritations. This study will be conducted in the United States.
Read the detailed description
The study will consist of six (6) scheduled visits: Screening and/or Baseline Visit (Day -7 to -1), Eligibility Confirmation/Randomization/1st Treatment Visit (Day 1), Week 2 Follow-Up Visit (Day 14), Week 4 Follow-Up Visit (Day 28), Week 8 Follow-Up/Treatment Discontinuation Visit (Day 56) and Exit Visit (Day 63). The expected individual duration of participation in the study is approximately 10 weeks with approximately 56 days of exposure to the investigational product.
- Conditions
- Ocular Redness
- Being tested
- Apraclonidine Hydrochloride Ophthalmic Solution, Vehicle
- Keywords
- Eye redness, Irritated eyes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apraclonidine Hydrochloride Ophthalmic SolutionDrug
Also called FID 123320
Investigational ophthalmic solution applied topically to the eye with a dropper bottle
VehicleDrug
Vehicle (inactive ingredients) applied topically to the eye with a dropper bottle
| Study group | Role | What they receive |
|---|---|---|
| Apraclonidine Hydrochloride Ophthalmic Solution | Experimental | One drop in each eye on Day 1, followed by 2 drops in each eye on Day 2 onward for approximately 8 weeks Receives: Drug: Apraclonidine Hydrochloride Ophthalmic Solution |
| Vehicle | Placebo comparator | One drop in each eye on Day 1, followed by 2 drops in each eye on Day 2 onward for approximately 8 weeks 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
Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe). This endpoint is co-primary with the 10 hours post-instillation endpoint.
Measured: Day 1: Pretreatment; 15 minutes post-treatment
Mean change from baseline in investigator-assessed ocular redness at 10 hours (600 minutes) post-instillation on Day 1
Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe). This endpoint is co-primary with the 15 minutes post-instillation endpoint.
Measured: Day 1: Pretreatment; 10 hours (600 minutes) post-treatment
Secondary outcomes (3)
Mean change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1
Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe).
Measured: Day 1: Pretreatment; 1 minute post-treatment
Mean change from baseline in investigator-assessed ocular redness at 8 hours (480 minutes) post-instillation on Day 1
Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe).
Measured: Day 1: Pretreatment; 8 hours (480 minutes) post-treatment
Mean change from baseline in investigator-assessed ocular redness at 12 hours (720 minutes) post-instillation on Day 1
Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe).
Measured: Day 1: Pretreatment; 12 hours (720 minutes) post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start21 Aug 2024
- Primary completion14 Nov 2024
- Study completion8 Jan 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
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Principal Clinical Trial Lead, Pharma, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444529
- Sponsor's protocol ID
- DEW422-C001
- Status last verified
- Oct 2025
- First submitted
- 31 May 2024
- Last updated
- 23 Oct 2025
- 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 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Masked Comparison of Apraclonidine Hydrochloride Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness
- ClinicalTrials.gov ID
- NCT06444529
- Acronym / sponsor ID
- DEW422-C001
- Conditions
- Ocular Redness
- Keywords
- Eye redness, Irritated eyes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- 14 Nov 2024 (actual)
- Study completion
- 8 Jan 2025 (actual)
- First posted
- 5 Jun 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 Apraclonidine Hydrochloride Ophthalmic Solution 0.125% when compared to Vehicle, in relieving redness of the eye due to minor eye irritations. This study will be conducted in the United States.
Detailed description
The study will consist of six (6) scheduled visits: Screening and/or Baseline Visit (Day -7 to -1), Eligibility Confirmation/Randomization/1st Treatment Visit (Day 1), Week 2 Follow-Up Visit (Day 14), Week 4 Follow-Up Visit (Day 28), Week 8 Follow-Up/Treatment Discontinuation Visit (Day 56) and Exit Visit (Day 63). The expected individual duration of participation in the study is approximately 10 weeks with approximately 56 days of exposure to the investigational product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apraclonidine Hydrochloride Ophthalmic Solution | Experimental | Drug: Apraclonidine Hydrochloride Ophthalmic SolutionOne drop in each eye on Day 1, followed by 2 drops in each eye on Day 2 onward for approximately 8 weeks |
| Vehicle | Placebo comparator | Drug: VehicleOne drop in each eye on Day 1, followed by 2 drops in each eye on Day 2 onward for approximately 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 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;
- History of redness relief drop use within the last 6 months, or a desire to use over-the-counter (OTC) eye drops for redness relief;
- Females capable of becoming pregnant: Agree to urine pregnancy tests and the use of medically acceptable forms of birth control throughout the study;
Key exclusion criteria (6 listed)
- Known contraindications or sensitivities to the use of any of the investigational drug(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;
- Ocular conditions that, in the opinion of the investigator, could affect the subject's safety or study parameters (i.e., could affect ocular redness, intraocular pressure, or eyelid position);
- Disallowed medications or devices as specified in the protocol;
- Planned surgery (ocular or systemic) during the study period or within 30 days after the study period;
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 Hydrochloride Ophthalmic SolutionAlso: FID 123320Investigational ophthalmic solution applied topically to the eye with a dropper bottle | Drug | Apraclonidine Hydrochloride Ophthalmic Solution |
| VehicleVehicle (inactive ingredients) applied topically to the eye with a dropper bottle | Drug | Vehicle |
Primary outcome
Mean change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1
Time frame: Day 1: Pretreatment; 15 minutes post-treatment
Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe). This endpoint is co-primary with the 10 hours post-instillation endpoint.
Mean change from baseline in investigator-assessed ocular redness at 10 hours (600 minutes) post-instillation on Day 1
Time frame: Day 1: Pretreatment; 10 hours (600 minutes) post-treatment
Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe). This endpoint is co-primary with the 15 minutes post-instillation endpoint.
3 secondary outcomes
Mean change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1
Time frame: Day 1: Pretreatment; 1 minute post-treatment
Mean change from baseline in investigator-assessed ocular redness at 8 hours (480 minutes) post-instillation on Day 1
Time frame: Day 1: Pretreatment; 8 hours (480 minutes) post-treatment
Mean change from baseline in investigator-assessed ocular redness at 12 hours (720 minutes) post-instillation on Day 1
Time frame: Day 1: Pretreatment; 12 hours (720 minutes) post-treatment
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 23 Oct 2025.
- 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.
Principal 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 Hydrochloride Ophthalmic Solution in people with Ocular Redness, 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 8 inclusion and 6 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 23 Oct 2025. 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?
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 (time frame: Day 1: Pretreatment; 15 minutes post-treatment). 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 23 Oct 2025.