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

Last updated: January 27, 2025
Sponsor: Bausch & Lomb Incorporated
Overall Status: Active - Not Recruiting

Phase

3

Condition

Hives (Urticaria)

Rash

Skin Wounds

Treatment

BTOS-HA

Lumify®

Clinical Study ID

NCT06803654
BL-CO01-LUMHA-1301
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Voluntarily provide written informed consent

  2. ≥18 years of age

  3. Able and willing to follow instructions, including participation in all trialassessments and visits

  4. History of vasoconstrictor (redness relief drops) use within the last 6 months, or adesire to use over the counter (OTC) vasoconstrictors for redness relief

  5. Able to self-administer eye drops satisfactorily

  6. A calculated best-corrected (if necessary) visual acuity of 0.3 logarithm of theminimum angle of resolution (logMAR) or better in each eye, as measured using anEarly Treatment Diabetic Retinopathy Study (ETDRS) chart

  7. At Visit 2 (Day 1), show a baseline redness score >1 in both eyes as scored by theinvestigator using the Investigator Ocular Redness Scale (range 0-4)

  8. Stable ocular health (defined as no ocular conditions requiring therapy or surgicalintervention during the study)

  9. If female and of childbearing potential (WOCBP):

  • Agree to have urine pregnancy testing performed at Day 1 (must be negative) andat exit visit, and

  • Must not be nursing or lactating, and

  • Must agree to use at least 1 medically acceptable form of birth control for atleast 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 ofinvestigational drug at Visit 4 (Day 29) NOTE: WOCBP include all females whohave experienced menarche and have not experienced menopause (as defined byamenorrhea for greater than 12 consecutive months) or have not undergonesuccessful surgical sterilization (hysterectomy, bilateral tubal ligation, orbilateral oophorectomy) NOTE: Acceptable forms of birth control include:

  • Mechanical (spermicide in conjunction with a barrier such as a diaphragm orcondom)

  • Hormonal contraceptive (oral, injectable, implantable, or transdermal)

  • Intrauterine device, or

  • Surgical sterilization of male partner at least 3 months prior to the firstdose of investigational drug at Visit 2 (Day 1) NOTE: For nonsexually activefemale subjects, abstinence may be regarded as an adequate method of birthcontrol when this is in line with the preferred and usual lifestyle of thesubject; however, if the subject becomes sexually active during the trial, shemust agree to use adequate birth control as defined above for the remainder ofthe trial

  1. If male and with female partner (WOCBP), must use at least 1 medically acceptableform of birth control

NOTE: Acceptable forms of birth control include:

  • True abstinence (when this is in line with the preferred and usual lifestyle of thesubject), 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 spermicidalfoam/gel/film/cream/suppository at least 14 days prior to the first dose ofinvestigational drug (Day 1) and for 1 month after the last dose of theinvestigational drug at Visit 4 (Day 29)

Exclusion

Exclusion Criteria:

  1. Known contraindications or sensitivity to the use of any of the investigationaldrug(s) or their components, or any other medications required by the protocol

  2. Ocular surgery within 3 months prior to screening or expected during the studyand/or a history of refractive surgery within the past 6 months

  3. Have the presence of an active ocular infection (bacterial, viral, or fungal) orpositive history of an ocular herpetic infection

  4. Use any of the following disallowed medications during the period indicated prior torandomization or planned use during the study:

  5. All topical ophthalmic agents including artificial tear products, eye whiteners (e.g., vasoconstrictors), ocular decongestants, ocular antihistamines, ocularcorticosteroids, dilating drops (excluding dilated ophthalmoscopy exam at Visit 2), and contact lenses: 5 days

  6. Systemic antihistamines or decongestants: 7 days

  7. Systemic corticosteroids or cancer chemotherapy, and/or any other systemicmedications which the investigator feels may confound study data, put thesubject at risk or interfere with subject's study participation: 14 days

  8. Have prior (within 7 days of beginning investigational drug) or currently activesignificant illness that could compromise participation, in the opinion of theinvestigator

  9. Have prior (within 30 days of beginning investigational drug) or anticipatedconcurrent use of an investigational drug or device during the study period

  10. Have an ocular or systemic condition or a situation which, in the investigator'sopinion, may put the subject at increased risk, confound study data, or interferesignificantly with the subject's study participation

  11. Have planned surgery (ocular or systemic) during the trial period or within 30 daysafter the study period

  12. Have a diagnosis of ocular hypertension or glaucoma at screening

  13. Nursing, lactating, pregnant, planning a pregnancy, or a positive urine pregnancytest at Visit 2 (Day 1)

Study Design

Total Participants: 574
Treatment Group(s): 2
Primary Treatment: BTOS-HA
Phase: 3
Study Start date:
March 26, 2025
Estimated Completion Date:
August 12, 2025