Ocular RednessPhase 3NCT05360784
"Efficacy and Safety of Brimonidine Tartrate Preservative-Free Formulation in Adults With Ocular Redness"
A Phase 3 study testing Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation and Lumify® (brimonidine tartrate ophthalmic solution 0.025%) in people with Ocular Redness, run by Bausch & Lomb Incorporated at 6 sites in United States.
Trial summary
This is a multi-center, double-masked, randomized, active-controlled, parallel-group, efficacy and safety study that will enroll 386 participants at up to six clinical sites. Participants with ocular redness will be randomized to receive either brimonidine tartrate ophthalmic solution 0.025%, preservative-free… 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?
- Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation and Lumify® (brimonidine tartrate ophthalmic solution 0.025%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 6 sitesUnited States
- Study dates
- 13 May 2022to 23 Nov 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Be at least 18 years of age at the time of Informed Consent signing of either gender and any race or ethnicity;
- Provide written informed consent and sign the HIPAA form;
- Be willing and able to follow all instructions and attend all study visits;
- Have a history of vasoconstrictor (redness relief drops) use within the last 6 months, or a desire to use OTC vasoconstrictors for redness relief;
- Be able to self-administer eye drops satisfactorily or have a subject's care provider at home1 routinely available for this purpose;
- (If female and of childbearing potential) agree to have urine pregnancy testing performed at Visit 1 (must be negative) and at exit visit; must not be lactating; and must agree to use at least 1 medically acceptable form of birth control2 throughout the study duration and for at least 14 days prior to the first dose of study drug (Visit 1) and for 1 month after the last dose of investigational drug. Note: Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) and have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy);
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- (If male and with female partner of childbearing potential) must use at least 1 medically acceptable form of birth control3;
- A calculated best-corrected (if necessary) visual acuity of 0.3 logMAR or better in each eye, as measured using an ETDRS chart;
- At Visit 1 (Baseline), show a baseline redness score >1 unit (ie, greater than 1 unit) in both eyes on a 0 to 4 unit scale as scored by the Investigator using the Investigator Ocular Redness Scale;
- Have stable ocular health (defined as no ocular conditions requiring therapy or surgical intervention during the study).
Who cannot join
- Have known contraindications or sensitivity to the use of any of the investigational drug(s) or their components, or any other medications required by the protocol;
- Have had ocular surgical intervention within 3 months prior to screening or during the study and/or a history of refractive surgery within the past 6 months;
- Have the presence of an active ocular infection (bacterial, viral, or fungal) or positive history of an ocular herpetic infection at any visit;
- Use any of the following disallowed medications during the period indicated prior to screening and for the duration of the study:
- All topical ophthalmic agents including artificial tear products, eye whiteners (e.g., vasoconstrictors), ocular decongestants, ocular antihistamines, ocular corticosteroids, dilating drops, (excluding dilated ophthalmoscopy exam at Visit 1) and contact lenses: 5 days
- Systemic antihistamines or decongestants: 7 days
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- Systemic corticosteroids or cancer chemotherapy, and/or any other systemic medications which the investigator feels may confound study data, or interfere with subject's study participation: 14 days
- Have prior (within 7 days of beginning investigational drug) or currently active significant illness that could compromise participation, in the opinion of the investigator;
- Have prior (within 30 days of beginning investigational drug) or anticipated concurrent use of an investigational drug or device during the study period;
- Have an ocular or systemic condition or a situation which, in the investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation;
- Have planned surgery (ocular or systemic) during the trial period or within 30 days after the study period;
- Be currently breast feeding or planning to breast feed during the study period or is a female who is currently pregnant, is planning a pregnancy, or has a positive urine pregnancy test at Visit 1;
- Have a diagnosis of ocular hypertension or glaucoma at screening;
- Have symptoms that, in the opinion of the investigator, may be associated with COVID-19 or in the last 14 days came into contact with someone diagnosed with COVID-19.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Bausch Site 01
Andover, Massachusetts, 01810
Bausch Site 06
Clinton, Utah, 84015
Bausch Site 04
Colorado Springs, Colorado, 80907
Bausch Site 05
Louisville, Kentucky, 40206
Bausch Site 02
Memphis, Tennessee, 33119
Bausch Site 03
Shelby, North Carolina, 28150
About this study
Official title: The Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% Preservative-Free Formulation With Lumify® 0.025% in Adult Subjects With Ocular Redness
This is a multi-center, double-masked, randomized, active-controlled, parallel-group, efficacy and safety study that will enroll 386 participants at up to six clinical sites. Participants with ocular redness will be randomized to receive either brimonidine tartrate ophthalmic solution 0.025%, preservative-free formulation, or Lumify® (brimonidine tartrate ophthalmic solution 0.025%). Participants will be treated with study drug for approximately 4 weeks.
- Conditions
- Ocular Redness
- Being tested
- Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation, Lumify® (brimonidine tartrate ophthalmic solution 0.025%)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulationDrug
Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation. Participants will instill 1 drop of the assigned investigational drug in each eye 4 times a day approximately 4 hours apart for up to 4 consecutive weeks.
Lumify® (brimonidine tartrate ophthalmic solution 0.025%)Drug
Lumify® (brimonidine tartrate ophthalmic solution 0.025%). Participants will instill 1 drop of the assigned investigational drug in each eye 4 times a day approximately 4 hours apart for up to 4 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Brimonidine tartrate preservation-free | Experimental | Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation Receives: Drug: Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation |
| Lumify® | Active comparator | Lumify® (brimonidine tartrate ophthalmic solution 0.025%) Receives: Drug: Lumify® (brimonidine tartrate ophthalmic solution 0.025%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Redness
Ocular redness score evaluated by the investigator from 5 minutes to 240 minutes after investigational drug instillation (0-4 unit scale, where 0 = None and 4 = Extremely severe).
Measured: Assessed at 5, 15, 30, 60, 90,120,180, 240 minutes post instillation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start13 May 2022
- Primary completion23 Nov 2022
- Study completion23 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ocular RednessStudies of the same condition, open and under way.
- 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
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Donatello, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360784
- Sponsor's protocol ID
- 908
- Status last verified
- Jun 2023
- First submitted
- 29 Apr 2022
- Last updated
- 26 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Toyos M, DiVito M, Messmer EM, McGee S, Peterson J, Patel A, Pattar G, Evans DG, Vollmer PM, Wesley G. A Multicenter Randomized Double-Masked Study Comparing Preservative-free Brimonidine Tartrate Ophthalmic Solution 0.025% with LUMIFY(R) 0.025% for Ocular Redness in Adults. Ophthalmol Ther. 2025 Sep;14(9):2283-2299. doi: 10.1007/s40123-025-01194-z. Epub 2025 Jul 25.
PubMed 40711722
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% Preservative-Free Formulation With Lumify® 0.025% in Adult Subjects With Ocular Redness
- ClinicalTrials.gov ID
- NCT05360784
- Acronym / sponsor ID
- 908
- Conditions
- Ocular Redness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 13 May 2022 (actual)
- Primary completion
- 23 Nov 2022 (actual)
- Study completion
- 23 Nov 2022 (actual)
- First posted
- 4 May 2022 (actual)
- Results
- Posted 26 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, double-masked, randomized, active-controlled, parallel-group, efficacy and safety study that will enroll 386 participants at up to six clinical sites. Participants with ocular redness will be randomized to receive either brimonidine tartrate ophthalmic solution 0.025%, preservative-free formulation, or Lumify® (brimonidine tartrate ophthalmic solution 0.025%). Participants will be treated with study drug for approximately 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brimonidine tartrate preservation-free | Experimental | Drug: Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulationBrimonidine tartrate ophthalmic solution 0.025% preservative-free formulation |
| Lumify® | Active comparator | Drug: Lumify® (brimonidine tartrate ophthalmic solution 0.025%)Lumify® (brimonidine tartrate ophthalmic solution 0.025%) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Be at least 18 years of age at the time of Informed Consent signing of either gender and any race or ethnicity;
- Provide written informed consent and sign the HIPAA form;
- Be willing and able to follow all instructions and attend all study visits;
- Have a history of vasoconstrictor (redness relief drops) use within the last 6 months, or a desire to use OTC vasoconstrictors for redness relief;
- Be able to self-administer eye drops satisfactorily or have a subject's care provider at home1 routinely available for this purpose;
Key exclusion criteria (14 listed)
- Have known contraindications or sensitivity to the use of any of the investigational drug(s) or their components, or any other medications required by the protocol;
- Have had ocular surgical intervention within 3 months prior to screening or during the study and/or a history of refractive surgery within the past 6 months;
- Have the presence of an active ocular infection (bacterial, viral, or fungal) or positive history of an ocular herpetic infection at any visit;
- Use any of the following disallowed medications during the period indicated prior to screening and for the duration of the study:
- Have prior (within 7 days of beginning investigational drug) or currently active significant illness that could compromise participation, in the opinion of the investigator;
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 |
|---|---|---|
| Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulationBrimonidine tartrate ophthalmic solution 0.025% preservative-free formulation. Participants will instill 1 drop of the assigned investigational drug in each eye 4 times a day approximately 4 hours apart for up to 4 consecutive weeks. | Drug | Brimonidine tartrate preservation-free |
| Lumify® (brimonidine tartrate ophthalmic solution 0.025%)Lumify® (brimonidine tartrate ophthalmic solution 0.025%). Participants will instill 1 drop of the assigned investigational drug in each eye 4 times a day approximately 4 hours apart for up to 4 consecutive weeks. | Drug | Lumify® |
Primary outcome
Ocular Redness
Time frame: Assessed at 5, 15, 30, 60, 90,120,180, 240 minutes post instillation.
Ocular redness score evaluated by the investigator from 5 minutes to 240 minutes after investigational drug instillation (0-4 unit scale, where 0 = None and 4 = Extremely severe).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40711722Toyos M, DiVito M, Messmer EM, McGee S, Peterson J, Patel A, Pattar G, Evans DG, Vollmer PM, Wesley G. A Multicenter Randomized Double-Masked Study Comparing Preservative-free Brimonidine Tartrate Ophthalmic Solution 0.025% with LUMIFY(R) 0.025% for Ocular Redness in Adults. Ophthalmol Ther. 2025 Sep;14(9):2283-2299. doi: 10.1007/s40123-025-01194-z. Epub 2025 Jul 25.
- Individual participant dataSharing planned: Undecided
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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.
Daniel Donatello study director
Bausch & Lomb Incorporated
6 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 Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation and Lumify® (brimonidine tartrate ophthalmic solution 0.025%) in people with Ocular Redness, run by Bausch & Lomb Incorporated at 6 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 10 inclusion and 14 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 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. 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?
Yes. Results are posted in the registry (first posted 26 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ocular Redness (time frame: Assessed at 5, 15, 30, 60, 90,120,180, 240 minutes post instillation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05360784, which also lists 1 linked publication.
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 26 Aug 2024.