"Efficacy and Safety of Brimonidine Tartrate Preservative-Free Formulation in Adults With Ocular Redness"
Primary Purpose
Ocular Redness
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation
Lumify® (brimonidine tartrate ophthalmic solution 0.025%)
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Redness
Eligibility Criteria
Inclusion Criteria:
- Be at least 18 years of age at the time of Informed Consent signing of either gender and any race or ethnicity;
- Provide written informed consent and sign the HIPAA form;
- Be willing and able to follow all instructions and attend all study visits;
- Have a history of vasoconstrictor (redness relief drops) use within the last 6 months, or a desire to use OTC vasoconstrictors for redness relief;
- Be able to self-administer eye drops satisfactorily or have a subject's care provider at home1 routinely available for this purpose;
- (If female and of childbearing potential) agree to have urine pregnancy testing performed 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 control2 throughout the study duration and for at least 14 days prior to the first dose of study 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 have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) and have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy);
- (If male and with female partner of childbearing potential) must use at least 1 medically acceptable form of birth control3;
- A calculated best-corrected (if necessary) visual acuity of 0.3 logMAR or better in each eye, as measured using an ETDRS chart;
- At Visit 1 (Baseline), show a baseline redness score >1 unit (ie, greater than 1 unit) in both eyes on a 0 to 4 unit scale as scored by the Investigator using the Investigator Ocular Redness Scale;
- Have stable ocular health (defined as no ocular conditions requiring therapy or surgical intervention during the study).
Exclusion Criteria:
- Have 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;
- Have had ocular surgical intervention within 3 months prior to screening or during the study and/or a history of refractive surgery within the past 6 months;
- Have the presence of an active ocular infection (bacterial, viral, or fungal) or positive history of an ocular herpetic infection at any visit;
Use any of the following disallowed medications during the period indicated prior to screening and for the duration of 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 1) and contact lenses: 5 days
- Systemic antihistamines or decongestants: 7 days
- Systemic corticosteroids or cancer chemotherapy, and/or any other systemic medications which the investigator feels may confound study data, 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;
- Have planned surgery (ocular or systemic) during the trial period or within 30 days after the study period;
- Be currently breast feeding or planning to breast feed during the study period or is a female who is currently pregnant, is planning a pregnancy, or has a positive urine pregnancy test at Visit 1;
- Have a diagnosis of ocular hypertension or glaucoma at screening;
- Have symptoms that, in the opinion of the investigator, may be associated with COVID-19 or in the last 14 days came into contact with someone diagnosed with COVID-19.
Sites / Locations
- Bausch Site 04Recruiting
- Bausch Site 05Recruiting
- Bausch Site 01Recruiting
- Bausch Site 03Recruiting
- Bausch Site 02Recruiting
- Bausch Site 06Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Brimonidine tartrate preservation-free
Lumify®
Arm Description
Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation
Lumify® (brimonidine tartrate ophthalmic solution 0.025%)
Outcomes
Primary Outcome Measures
Ocular redness
Ocular redness score evaluated by the investigator prior to investigational drug instillation and after investigational drug instillation (0-4 unit scale, where 0 = Normal and 4 is the most redness).
Secondary Outcome Measures
Full Information
NCT ID
NCT05360784
First Posted
April 29, 2022
Last Updated
August 30, 2023
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT05360784
Brief Title
"Efficacy and Safety of Brimonidine Tartrate Preservative-Free Formulation in Adults With Ocular Redness"
Official Title
The Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% Preservative-Free Formulation With Lumify® 0.025% in Adult Subjects With Ocular Redness
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 13, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Redness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
386 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Brimonidine tartrate preservation-free
Arm Type
Experimental
Arm Description
Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation
Arm Title
Lumify®
Arm Type
Active Comparator
Arm Description
Lumify® (brimonidine tartrate ophthalmic solution 0.025%)
Intervention Type
Drug
Intervention Name(s)
Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation
Intervention Description
Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation. Participants will instill 1 drop of the assigned investigational drug in each eye 4 times a day approximately 4 hours apart for up to 4 consecutive weeks.
Intervention Type
Drug
Intervention Name(s)
Lumify® (brimonidine tartrate ophthalmic solution 0.025%)
Intervention Description
Lumify® (brimonidine tartrate ophthalmic solution 0.025%). Participants will instill 1 drop of the assigned investigational drug in each eye 4 times a day approximately 4 hours apart for up to 4 consecutive weeks.
Primary Outcome Measure Information:
Title
Ocular redness
Description
Ocular redness score evaluated by the investigator prior to investigational drug instillation and after investigational drug instillation (0-4 unit scale, where 0 = Normal and 4 is the most redness).
Time Frame
4 hours after instillation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be at least 18 years of age at the time of Informed Consent signing of either gender and any race or ethnicity;
Provide written informed consent and sign the HIPAA form;
Be willing and able to follow all instructions and attend all study visits;
Have a history of vasoconstrictor (redness relief drops) use within the last 6 months, or a desire to use OTC vasoconstrictors for redness relief;
Be able to self-administer eye drops satisfactorily or have a subject's care provider at home1 routinely available for this purpose;
(If female and of childbearing potential) agree to have urine pregnancy testing performed 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 control2 throughout the study duration and for at least 14 days prior to the first dose of study 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 have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) and have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy);
(If male and with female partner of childbearing potential) must use at least 1 medically acceptable form of birth control3;
A calculated best-corrected (if necessary) visual acuity of 0.3 logMAR or better in each eye, as measured using an ETDRS chart;
At Visit 1 (Baseline), show a baseline redness score >1 unit (ie, greater than 1 unit) in both eyes on a 0 to 4 unit scale as scored by the Investigator using the Investigator Ocular Redness Scale;
Have stable ocular health (defined as no ocular conditions requiring therapy or surgical intervention during the study).
Exclusion Criteria:
Have 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;
Have had ocular surgical intervention within 3 months prior to screening or during the study and/or a history of refractive surgery within the past 6 months;
Have the presence of an active ocular infection (bacterial, viral, or fungal) or positive history of an ocular herpetic infection at any visit;
Use any of the following disallowed medications during the period indicated prior to screening and for the duration of 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 1) and contact lenses: 5 days
Systemic antihistamines or decongestants: 7 days
Systemic corticosteroids or cancer chemotherapy, and/or any other systemic medications which the investigator feels may confound study data, 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;
Have planned surgery (ocular or systemic) during the trial period or within 30 days after the study period;
Be currently breast feeding or planning to breast feed during the study period or is a female who is currently pregnant, is planning a pregnancy, or has a positive urine pregnancy test at Visit 1;
Have a diagnosis of ocular hypertension or glaucoma at screening;
Have symptoms that, in the opinion of the investigator, may be associated with COVID-19 or in the last 14 days came into contact with someone diagnosed with COVID-19.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Donatello
Phone
5853385306
Email
Daniel.Donatello@bausch.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Donatello
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Bausch Site 04
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 05
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 01
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 03
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 02
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
33119
Country
United States
Individual Site Status
Recruiting
Facility Name
Bausch Site 06
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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"Efficacy and Safety of Brimonidine Tartrate Preservative-Free Formulation in Adults With Ocular Redness"
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