A Multicenter Randomized Double-Masked Study Comparing Preservative-free Brimonidine Tartrate Ophthalmic Solution 0.025% with LUMIFY® 0.025% for Ocular Redness in Adults
Abstract Introduction Ocular redness is common, can affect quality of life, and can be relieved by short-term use of topical adrenergic receptor (AR) agonists. Brimonidine tartrate ophthalmic solution 0.025% (LUMIFY® 0.025%) is the first α2-AR-selective agonist approved for ocular redness. The prese...
Saved in:
| Main Authors: | , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Adis, Springer Healthcare
2025-07-01
|
| Series: | Ophthalmology and Therapy |
| Subjects: | |
| Online Access: | https://doi.org/10.1007/s40123-025-01194-z |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849226551821860864 |
|---|---|
| author | Melissa Toyos Melinda DiVito Elisabeth M. Messmer Selina McGee Jared Peterson Assem Patel Guruprasad Pattar David G. Evans Patrick M. Vollmer Gina Wesley |
| author_facet | Melissa Toyos Melinda DiVito Elisabeth M. Messmer Selina McGee Jared Peterson Assem Patel Guruprasad Pattar David G. Evans Patrick M. Vollmer Gina Wesley |
| author_sort | Melissa Toyos |
| collection | DOAJ |
| description | Abstract Introduction Ocular redness is common, can affect quality of life, and can be relieved by short-term use of topical adrenergic receptor (AR) agonists. Brimonidine tartrate ophthalmic solution 0.025% (LUMIFY® 0.025%) is the first α2-AR-selective agonist approved for ocular redness. The preservative benzalkonium chloride (BAK) maintains ophthalmic solution sterility, reducing the risk of ocular infections, but may cause symptoms of ocular surface disease (OSD) in some patients. A BAK-free formulation of LUMIFY 0.025% (BTOS-PF 0.025%) could offer a solution for BAK-sensitive patients. Methods This randomized, active-controlled, multicenter study aimed to establish non-inferior efficacy of BTOS-PF 0.025% to LUMIFY 0.025% and compare safety. Randomized participants received either formulation instilled as a single drop four times daily, for 4 weeks. The primary endpoint was investigator-assessed ocular redness at 5, 15, 30, 60, 90, 120, 180, and 240 min post-instillation at visit 1 (day 1). Eight hierarchical secondary endpoints included additional post-instillation timepoints at visit 1 and visits 2 and 3 (days 14 and 28), and participant-assessed redness. Results BTOS-PF 0.025% was statistically non-inferior to LUMIFY 0.025% for ocular redness reduction across the eight timepoints at visit 1. Efficacy for both formulations was seen as early as 1 min and up to 8 h post-instillation. BTOS-PF 0.025% performed similarly to LUMIFY 0.025% after 14 and 28 days, rebound redness rates were low and similar, and total clearance of ocular redness and participant-evaluated redness were similar. The safety profile of both formulations was similar, with no severe or serious ocular events. Conclusions BTOS-PF 0.025% was non-inferior to LUMIFY 0.025% in reducing ocular redness in adults, was well-tolerated, and offers an alternative topical solution, without loss of efficacy or compromised safety, for patients who prefer a preservative-free formulation or are at increased risk of OSD. Clinical Trial Registration ClinicalTrials.gov identifier: NCT05360784. Date of registration: 29 April 2022. |
| format | Article |
| id | doaj-art-18efe9a9ffef4cd3a7d73d9b5eb71305 |
| institution | Kabale University |
| issn | 2193-8245 2193-6528 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Adis, Springer Healthcare |
| record_format | Article |
| series | Ophthalmology and Therapy |
| spelling | doaj-art-18efe9a9ffef4cd3a7d73d9b5eb713052025-08-24T11:11:44ZengAdis, Springer HealthcareOphthalmology and Therapy2193-82452193-65282025-07-011492283229910.1007/s40123-025-01194-zA Multicenter Randomized Double-Masked Study Comparing Preservative-free Brimonidine Tartrate Ophthalmic Solution 0.025% with LUMIFY® 0.025% for Ocular Redness in AdultsMelissa Toyos0Melinda DiVito1Elisabeth M. Messmer2Selina McGee3Jared Peterson4Assem Patel5Guruprasad Pattar6David G. Evans7Patrick M. Vollmer8Gina Wesley9Toyos ClinicBausch + LombDepartment of Ophthalmology, Ludwig-Maximilian UniversityBeSpoke VisionMountain View Eye CenterVita Eye ClinicThe Eye Care InstituteTotal Eye CareVita Eye ClinicComplete Eye Care of MedinaAbstract Introduction Ocular redness is common, can affect quality of life, and can be relieved by short-term use of topical adrenergic receptor (AR) agonists. Brimonidine tartrate ophthalmic solution 0.025% (LUMIFY® 0.025%) is the first α2-AR-selective agonist approved for ocular redness. The preservative benzalkonium chloride (BAK) maintains ophthalmic solution sterility, reducing the risk of ocular infections, but may cause symptoms of ocular surface disease (OSD) in some patients. A BAK-free formulation of LUMIFY 0.025% (BTOS-PF 0.025%) could offer a solution for BAK-sensitive patients. Methods This randomized, active-controlled, multicenter study aimed to establish non-inferior efficacy of BTOS-PF 0.025% to LUMIFY 0.025% and compare safety. Randomized participants received either formulation instilled as a single drop four times daily, for 4 weeks. The primary endpoint was investigator-assessed ocular redness at 5, 15, 30, 60, 90, 120, 180, and 240 min post-instillation at visit 1 (day 1). Eight hierarchical secondary endpoints included additional post-instillation timepoints at visit 1 and visits 2 and 3 (days 14 and 28), and participant-assessed redness. Results BTOS-PF 0.025% was statistically non-inferior to LUMIFY 0.025% for ocular redness reduction across the eight timepoints at visit 1. Efficacy for both formulations was seen as early as 1 min and up to 8 h post-instillation. BTOS-PF 0.025% performed similarly to LUMIFY 0.025% after 14 and 28 days, rebound redness rates were low and similar, and total clearance of ocular redness and participant-evaluated redness were similar. The safety profile of both formulations was similar, with no severe or serious ocular events. Conclusions BTOS-PF 0.025% was non-inferior to LUMIFY 0.025% in reducing ocular redness in adults, was well-tolerated, and offers an alternative topical solution, without loss of efficacy or compromised safety, for patients who prefer a preservative-free formulation or are at increased risk of OSD. Clinical Trial Registration ClinicalTrials.gov identifier: NCT05360784. Date of registration: 29 April 2022.https://doi.org/10.1007/s40123-025-01194-zBrimonidineBenzalkonium chlorideBrimonidine tartrate ophthalmic solution 0.025%HyperemiaLUMIFYOcular redness |
| spellingShingle | Melissa Toyos Melinda DiVito Elisabeth M. Messmer Selina McGee Jared Peterson Assem Patel Guruprasad Pattar David G. Evans Patrick M. Vollmer Gina Wesley A Multicenter Randomized Double-Masked Study Comparing Preservative-free Brimonidine Tartrate Ophthalmic Solution 0.025% with LUMIFY® 0.025% for Ocular Redness in Adults Ophthalmology and Therapy Brimonidine Benzalkonium chloride Brimonidine tartrate ophthalmic solution 0.025% Hyperemia LUMIFY Ocular redness |
| title | A Multicenter Randomized Double-Masked Study Comparing Preservative-free Brimonidine Tartrate Ophthalmic Solution 0.025% with LUMIFY® 0.025% for Ocular Redness in Adults |
| title_full | A Multicenter Randomized Double-Masked Study Comparing Preservative-free Brimonidine Tartrate Ophthalmic Solution 0.025% with LUMIFY® 0.025% for Ocular Redness in Adults |
| title_fullStr | A Multicenter Randomized Double-Masked Study Comparing Preservative-free Brimonidine Tartrate Ophthalmic Solution 0.025% with LUMIFY® 0.025% for Ocular Redness in Adults |
| title_full_unstemmed | A Multicenter Randomized Double-Masked Study Comparing Preservative-free Brimonidine Tartrate Ophthalmic Solution 0.025% with LUMIFY® 0.025% for Ocular Redness in Adults |
| title_short | A Multicenter Randomized Double-Masked Study Comparing Preservative-free Brimonidine Tartrate Ophthalmic Solution 0.025% with LUMIFY® 0.025% for Ocular Redness in Adults |
| title_sort | multicenter randomized double masked study comparing preservative free brimonidine tartrate ophthalmic solution 0 025 with lumify r 0 025 for ocular redness in adults |
| topic | Brimonidine Benzalkonium chloride Brimonidine tartrate ophthalmic solution 0.025% Hyperemia LUMIFY Ocular redness |
| url | https://doi.org/10.1007/s40123-025-01194-z |
| work_keys_str_mv | AT melissatoyos amulticenterrandomizeddoublemaskedstudycomparingpreservativefreebrimonidinetartrateophthalmicsolution0025withlumify0025forocularrednessinadults AT melindadivito amulticenterrandomizeddoublemaskedstudycomparingpreservativefreebrimonidinetartrateophthalmicsolution0025withlumify0025forocularrednessinadults AT elisabethmmessmer amulticenterrandomizeddoublemaskedstudycomparingpreservativefreebrimonidinetartrateophthalmicsolution0025withlumify0025forocularrednessinadults AT selinamcgee amulticenterrandomizeddoublemaskedstudycomparingpreservativefreebrimonidinetartrateophthalmicsolution0025withlumify0025forocularrednessinadults AT jaredpeterson amulticenterrandomizeddoublemaskedstudycomparingpreservativefreebrimonidinetartrateophthalmicsolution0025withlumify0025forocularrednessinadults AT assempatel amulticenterrandomizeddoublemaskedstudycomparingpreservativefreebrimonidinetartrateophthalmicsolution0025withlumify0025forocularrednessinadults AT guruprasadpattar amulticenterrandomizeddoublemaskedstudycomparingpreservativefreebrimonidinetartrateophthalmicsolution0025withlumify0025forocularrednessinadults AT davidgevans amulticenterrandomizeddoublemaskedstudycomparingpreservativefreebrimonidinetartrateophthalmicsolution0025withlumify0025forocularrednessinadults AT patrickmvollmer amulticenterrandomizeddoublemaskedstudycomparingpreservativefreebrimonidinetartrateophthalmicsolution0025withlumify0025forocularrednessinadults AT ginawesley amulticenterrandomizeddoublemaskedstudycomparingpreservativefreebrimonidinetartrateophthalmicsolution0025withlumify0025forocularrednessinadults AT melissatoyos multicenterrandomizeddoublemaskedstudycomparingpreservativefreebrimonidinetartrateophthalmicsolution0025withlumify0025forocularrednessinadults AT melindadivito multicenterrandomizeddoublemaskedstudycomparingpreservativefreebrimonidinetartrateophthalmicsolution0025withlumify0025forocularrednessinadults AT elisabethmmessmer multicenterrandomizeddoublemaskedstudycomparingpreservativefreebrimonidinetartrateophthalmicsolution0025withlumify0025forocularrednessinadults AT selinamcgee multicenterrandomizeddoublemaskedstudycomparingpreservativefreebrimonidinetartrateophthalmicsolution0025withlumify0025forocularrednessinadults AT jaredpeterson multicenterrandomizeddoublemaskedstudycomparingpreservativefreebrimonidinetartrateophthalmicsolution0025withlumify0025forocularrednessinadults AT assempatel multicenterrandomizeddoublemaskedstudycomparingpreservativefreebrimonidinetartrateophthalmicsolution0025withlumify0025forocularrednessinadults AT guruprasadpattar multicenterrandomizeddoublemaskedstudycomparingpreservativefreebrimonidinetartrateophthalmicsolution0025withlumify0025forocularrednessinadults AT davidgevans multicenterrandomizeddoublemaskedstudycomparingpreservativefreebrimonidinetartrateophthalmicsolution0025withlumify0025forocularrednessinadults AT patrickmvollmer multicenterrandomizeddoublemaskedstudycomparingpreservativefreebrimonidinetartrateophthalmicsolution0025withlumify0025forocularrednessinadults AT ginawesley multicenterrandomizeddoublemaskedstudycomparingpreservativefreebrimonidinetartrateophthalmicsolution0025withlumify0025forocularrednessinadults |