COMPLETED

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2025-05-22

Study Completion:2025-06-29

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06803654

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 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 at Visit 2 (Day 1), (defined as no ocular conditions requiring therapy or surgical intervention during the study).	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 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 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 (e.g., blepharitis, active ocular allergies, rosacea with peri-ocular involvement, uncontrolled diabetes, hypertension, or cardiovascular disease). 8. Have a diagnosis of ocular hypertension or glaucoma at screening 9. Any female who is nursing, lactating, pregnant, planning a pregnancy, or has a positive urine pregnancy test at Visit 2 (Day 1). 10. 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) * 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) 11. Any male who is unwilling to agree to use at least 1 medically acceptable form of birth control with female partner (FOCBP) * 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)

Inclusion Criteria

Exclusion 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. 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 at Visit 2 (Day 1), (defined as no ocular conditions requiring therapy or surgical intervention during the study).

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 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
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 (e.g., blepharitis, active ocular allergies, rosacea with peri-ocular involvement, uncontrolled diabetes, hypertension, or cardiovascular disease).
8. Have a diagnosis of ocular hypertension or glaucoma at screening
9. Any female who is nursing, lactating, pregnant, planning a pregnancy, or has a positive urine pregnancy test at Visit 2 (Day 1).
10. 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)
* 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)
11. Any male who is unwilling to agree to use at least 1 medically acceptable form of birth control with female partner (FOCBP)
* 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)

Contacts and Locations

Study Locations (Sites)

Site 102

Glendale, California, 91204

United States

Site 104

Newport Beach, California, 92663

United States

Site 111

Northbrook, Illinois, 60062

United States

Site 109

Pittsburg, Kansas, 66762

United States

Site 106

Louisville, Kentucky, 40206

United States

Site 103

Andover, Massachusetts, 01810

United States

Site 108

Garner, North Carolina, 27529

United States

Site 107

Shelby, North Carolina, 28150

United States

Site 112

Cranberry Township, Pennsylvania, 16066

United States

Site 101

Memphis, Tennessee, 38119

United States

Site 105

Smyrna, Tennessee, 37167

United States

Collaborators and Investigators

Sponsor: Bausch & Lomb Incorporated

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-22

Study Completion Date2025-06-29

Study Record Updates

Study Start Date2025-05-22

Study Completion Date2025-06-29

Terms related to this study

Additional Relevant MeSH Terms

Ocular Redness