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

Bausch + Lomb

Status and phase: Not yet enrolling; Phase 3

Conditions: Ocular Redness

Treatments: Drug: Lumify®; Drug: BTOS-HA

Study type: Interventional

Funder types: Industry

Identifiers

NCT06803654

BL-CO01-LUMHA-1301

Details and patient eligibility

About

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

Enrollment: 574 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Voluntarily provide written informed consent

2. ≥18 years of age

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

4. 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

5. Able to self-administer eye drops satisfactorily

6. 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

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

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

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

   • Agree to have urine pregnancy testing performed at Day 1 (must be negative) and at exit visit, and
   • Must not be nursing or lactating, and
   • Must 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: WOCBP 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 nonsexually 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

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

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 (Day 1) and for 1 month after the last dose of the investigational drug at Visit 4 (Day 29)

Exclusion criteria

1. 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

2. Ocular surgery within 3 months prior to screening or expected during the 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) or positive history of an ocular herpetic infection

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

   1. 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
   2. Systemic antihistamines or decongestants: 7 days
   3. 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

5. Have prior (within 7 days of beginning investigational drug) or currently active significant illness that could compromise participation, in the opinion of the investigator

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

7. 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

8. Have planned surgery (ocular or systemic) during the trial period or within 30 days after the study period

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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574 participants in 2 patient groups

Brimonidine tartrate ophthalmic solution 0.025% with sodium hyaluronate (BTOS-HA)

Experimental group

Treatment:

Drug: BTOS-HA

Brimonidine tartrate ophthalmic solution 0.025%

Active Comparator group

Treatment:

Drug: Lumify®