"Efficacy and Safety of Brimonidine Tartrate Preservative-Free Formulation in Adults With Ocular Redness"

Last updated: August 1, 2024
Sponsor: Bausch & Lomb Incorporated
Overall Status: Completed

Phase

3

Condition

Skin Wounds

Hives (Urticaria)

Rash

Treatment

Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation

Lumify® (brimonidine tartrate ophthalmic solution 0.025%)

Clinical Study ID

NCT05360784
908
  • Ages > 18
  • All Genders

Study 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 formulation, or Lumify® (brimonidine tartrate ophthalmic solution 0.025%). Participants will be treated with study drug for approximately 4 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Be at least 18 years of age at the time of Informed Consent signing of either genderand any race or ethnicity;

  2. Provide written informed consent and sign the HIPAA form;

  3. Be willing and able to follow all instructions and attend all study visits;

  4. Have a history of vasoconstrictor (redness relief drops) use within the last 6months, or a desire to use OTC vasoconstrictors for redness relief;

  5. Be able to self-administer eye drops satisfactorily or have a subject's careprovider at home1 routinely available for this purpose;

  6. (If female and of childbearing potential) agree to have urine pregnancy testingperformed 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 control2throughout the study duration and for at least 14 days prior to the first dose ofstudy 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 haveexperienced menarche and have not experienced menopause (as defined by amenorrheafor greater than 12 consecutive months) and have not undergone successful surgicalsterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy);

  7. (If male and with female partner of childbearing potential) must use at least 1medically acceptable form of birth control3;

  8. A calculated best-corrected (if necessary) visual acuity of 0.3 logMAR or better ineach eye, as measured using an ETDRS chart;

  9. At Visit 1 (Baseline), show a baseline redness score >1 unit (ie, greater than 1unit) in both eyes on a 0 to 4 unit scale as scored by the Investigator using theInvestigator Ocular Redness Scale;

  10. Have stable ocular health (defined as no ocular conditions requiring therapy orsurgical intervention during the study).

Exclusion

Exclusion Criteria:

  1. Have 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. Have had ocular surgical intervention within 3 months prior to screening or duringthe study and/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 at any visit;

  4. Use any of the following disallowed medications during the period indicated prior toscreening and for the duration of the study:

  • All topical ophthalmic agents including artificial tear products, eye whiteners (e.g., vasoconstrictors), ocular decongestants, ocular antihistamines, ocularcorticosteroids, dilating drops, (excluding dilated ophthalmoscopy exam atVisit 1) and contact lenses: 5 days

  • Systemic antihistamines or decongestants: 7 days

  • Systemic corticosteroids or cancer chemotherapy, and/or any other systemicmedications which the investigator feels may confound study data, or interferewith subject's study participation: 14 days

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

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

  3. 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;

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

  5. Be currently breast feeding or planning to breast feed during the study period or isa female who is currently pregnant, is planning a pregnancy, or has a positive urinepregnancy test at Visit 1;

  6. Have a diagnosis of ocular hypertension or glaucoma at screening;

  7. Have symptoms that, in the opinion of the investigator, may be associated withCOVID-19 or in the last 14 days came into contact with someone diagnosed withCOVID-19.

Study Design

Total Participants: 380
Treatment Group(s): 2
Primary Treatment: Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation
Phase: 3
Study Start date:
May 13, 2022
Estimated Completion Date:
November 23, 2022

Connect with a study center

  • Bausch Site 04

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Bausch Site 05

    Louisville, Kentucky 40206
    United States

    Site Not Available

  • Bausch Site 01

    Andover, Massachusetts 01810
    United States

    Site Not Available

  • Bausch Site 03

    Shelby, North Carolina 28150
    United States

    Site Not Available

  • Bausch Site 02

    Memphis, Tennessee 33119
    United States

    Site Not Available

  • Bausch Site 06

    Clinton, Utah 84015
    United States

    Site Not Available

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