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Ocular RednessPhase 3NCT06803654

A Study Comparing the Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% With Sodium Hyaluronate Relative to Lumify in Adult Subjects With Ocular Redness

A Phase 3 study testing BTOS-HA and Lumify® in people with Ocular Redness, run by Bausch & Lomb Incorporated at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To demonstrate the efficacy of BTOS-HA as non inferior to Lumify for treating ocular redness in a population of adult subjects. 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?
BTOS-HA and Lumify®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
578 participants
Where
11 sitesUnited States
Study dates
22 May 2025to 29 Jun 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

  • Voluntarily provide written informed consent
  • ≥18 years of age
  • Able and willing to follow instructions, including participation in all trial assessments and visits
  • History of vasoconstrictor (redness relief drops) use within the last 6 months, or a desire to use over the counter (OTC) vasoconstrictors for redness relief
  • Able to self-administer eye drops satisfactorily
  • A calculated best-corrected (if necessary) visual acuity of 0.3 logarithm of the minimum angle of resolution (logMAR) or better in each eye, as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart
  • Show a baseline redness score >1 in both eyes as scored by the investigator using the Investigator Ocular Redness Scale (range 0-4)
  • Stable ocular health at Visit 2 (Day 1), (defined as no ocular conditions requiring therapy or surgical intervention during the study).

Who cannot join

  • 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
  • Ocular surgery within 3 months prior to screening and/or a history of refractive surgery within the past 6 months, and/ or planned surgery (ocular or systemic) during the trial period or within 30 days after the study period
  • Have the presence of an active ocular infection (bacterial, viral, or fungal) or positive history of an ocular herpetic infection
  • Use any of the following disallowed medications during the period indicated prior to randomization or planned use during 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 2), and contact lenses: 5 days
  • Systemic antihistamines or decongestants: 7 days
Show all 24Show fewer
  • Systemic corticosteroids or cancer chemotherapy, and/or any other systemic medications which the investigator feels may confound study data, put the subject at risk 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 (e.g., blepharitis, active ocular allergies, rosacea with peri-ocular involvement, uncontrolled diabetes, hypertension, or cardiovascular disease).
  • Have a diagnosis of ocular hypertension or glaucoma at screening
  • Any female who is nursing, lactating, pregnant, planning a pregnancy, or has a positive urine pregnancy test at Visit 2 (Day 1).
  • Any female of childbearing potential (FOCBP) who is unwilling to: a) agree to have urine pregnancy testing performed at Visit 2 (Day 1), and b) agree to use at least 1 medically acceptable form of birth control for at least 14 days prior to the first dose of study drug at Visit 2 (Day 1), throughout the study duration, and for 1 month after the last dose of investigational drug at Visit 4 (Day 29) NOTE: FOCBP include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy)
  • NOTE: Acceptable forms of birth control include:
  • Mechanical (spermicide in conjunction with a barrier such as a diaphragm or condom)
  • Hormonal contraceptive (oral, injectable, implantable, or transdermal)
  • Intrauterine device, or
  • Surgical sterilization of male partner at least 3 months prior to the first dose of investigational drug at Visit 2 (Day 1)
  • NOTE: For non-sexually active female subjects, abstinence may be regarded as an adequate method of birth control when this is in line with the preferred and usual lifestyle of the subject; however, if the subject becomes sexually active during the trial, she must agree to use adequate birth control as defined above for the remainder of the trial
  • Any male who is unwilling to agree to use at least 1 medically acceptable form of birth control with female partner (FOCBP)
  • NOTE: Acceptable forms of birth control include:
  • True abstinence (when this is in line with the preferred and usual lifestyle of the subject), or
  • Vasectomy at least 3 months prior to the first dose of study drug at Visit 2 (Day 1)
  • Without a vasectomy, must use condoms with spermicidal foam/gel/film/cream/suppository at least 14 days prior to the first dose of investigational drug at Visit 2 (Day 1) and throughout the study duration, and for 1 month after the last dose of the investigational drug at Visit 4 (Day 29)

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Site 103

    Andover, Massachusetts, 01810

  • Site 112

    Cranberry Township, Pennsylvania, 16066

  • Site 108

    Garner, North Carolina, 27529

  • Site 102

    Glendale, California, 91204

  • Site 106

    Louisville, Kentucky, 40206

  • Site 101

    Memphis, Tennessee, 38119

  • Site 104

    Newport Beach, California, 92663

  • Site 111

    Northbrook, Illinois, 60062

  • Site 109

    Pittsburg, Kansas, 66762

  • Site 107

    Shelby, North Carolina, 28150

  • Site 105

    Smyrna, Tennessee, 37167

Other trials in United States

About this study

Official title: A Randomized, Multicenter, Double-Masked, Active-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% With Sodium Hyaluronate Relative to Lumify in Adult Subjects With Ocular Redness

To demonstrate the efficacy of BTOS-HA as non inferior to Lumify for treating ocular redness in a population of adult subjects.

Conditions
Ocular Redness
Being tested
BTOS-HA, Lumify®

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BTOS-HADrug

    Brimonidine tartrate ophthalmic solution 0.025% with sodium hyaluronate (BTOS-HA) administered as 1 topical ocular drop instilled into each eye (OU), 4 times daily (QID), approximately 4 hours apart

  • Lumify®Drug

    Brimonidine tartrate ophthalmic solution 0.025%, administered as 1 topical ocular drop instilled into each eye (OU), 4 times daily (QID), approximately 4 hours apart

Study groups in NCT06803654
Study groupRoleWhat they receive
Brimonidine tartrate ophthalmic solution 0.025% with sodium hyaluronate (BTOS-HA)ExperimentalNot described
Receives: Drug: BTOS-HA
Brimonidine tartrate ophthalmic solution 0.025%Active comparatorNot described
Receives: Drug: Lumify®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ocular redness score (0-4 unit scale, allowing half-unit increments) evaluated by the investigator at Visit 2 (Day 1)

    Ocular redness score (0-4 unit scale, allowing half-unit increments) evaluated by the investigator at Visit 2 (Day 1) prior to investigational drug instillation and after investigational drug instillation at 5(+1) minutes, 15(+1) minutes, 30(+1) minutes, 60(+10) minutes, 90(+10) minutes, 120(+15) minutes, 180(+15) minutes, 240(+15) minutes

    Measured: Assessed at Visit 2 (Day 1) prior to investigational drug instillation and after investigational drug instillation at 5(+1) minutes, 15(+1) minutes, 30(+1) minutes, 60(+10) minutes, 90(+10) minutes, 120(+15) minutes, 180(+15) minutes, 240(+15) minutes

Secondary outcomes (4)

  1. Change from pre-instillation ocular redness score (0-4 unit scale, allowing half-unit increments) evaluated by the investigator at Visit 2 (Day 1)

    Change from pre-instillation ocular redness score (0-4 unit scale, allowing half-unit increments) evaluated by the investigator at Visit 2 (Day 1) after investigational drug instillation evaluated hierarchically at: 1 (+0.5) minute, 360 (+15) minutes and 480 (+15) minutes

    Measured: Assessed at Visit 2 (Day 1) after investigational drug instillation evaluated hierarchically at: 1 (+0.5) minute, 360 (+15) minutes and 480 (+15) minutes

  2. Change from pre-instillation ocular redness score (0-4 unit scale, allowing half-unit increments) evaluated by the Investigator after investigational drug instillation evaluated hierarchically at Visit 3 (Day 15)

    Change from pre-instillation ocular redness score (0-4 unit scale, allowing half-unit increments) evaluated by the Investigator after investigational drug instillation evaluated hierarchically at Visit 3 (Day 15) 5 (+1) minutes and 15 (+1) minutes

    Measured: Assessed at Visit 3 (Day 15) 5 (+1) minutes and 15 (+1) minutes

  3. Change from pre-instillation ocular redness score (0-4 unit scale, allowing half-unit increments) evaluated by the Investigator after investigational drug instillation evaluated hierarchically at Visit 4 (Day 29)

    Change from pre-instillation ocular redness score (0-4 unit scale, allowing half-unit increments) evaluated by the Investigator after investigational drug instillation evaluated hierarchically at Visit 4 (Day 29) 5 (+1) minutes and 15 (+1) minutes

    Measured: Assessed at Visit 4 (Day 29) 5 (+1) minutes and 15 (+1) minutes

  4. Change from pre-instillation ocular redness score (0-4 unit scale, allowing half-unit increments) evaluated by the investigator after investigational drug instillation at Visit 2 (Day 1)

    Change from pre-instillation ocular redness score (0-4 unit scale, allowing half-unit increments) evaluated by the investigator after investigational drug instillation at Visit 2 (Day 1) evaluated hierarchically at 0.5 (+0.25) minute and 600 (+15) minutes

    Measured: Assessed at Visit 2 (Day 1) evaluated hierarchically at 0.5 (+0.25) minute and 600 (+15) minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2025
  2. Study start22 May 2025
  3. Primary completion29 Jun 2025
  4. Study completion29 Jun 2025

Resources

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
Single blind
Who is masked
Participant
Enrolment
578 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06803654
Sponsor's protocol ID
BL-CO01-LUMHA-1301
Status last verified
May 2026
First submitted
27 Jan 2025
Last updated
28 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BTOS-HA and Lumify® in people with Ocular Redness, run by Bausch & Lomb Incorporated at 11 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 24 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 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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?

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?

Ocular redness score (0-4 unit scale, allowing half-unit increments) evaluated by the investigator at Visit 2 (Day 1) (time frame: Assessed at Visit 2 (Day 1) prior to investigational drug instillation and after investigational drug instillation at 5(+1) minutes, 15(+1) minutes, 30(+1) minutes, 60(+10) minutes, 90(+10) minutes, 120(+15) minutes, 180(+15) minutes, 240(+15) minutes). 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 NCT06803654.

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 28 May 2026.

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