New NovaTear Carbomer Gel Completes Clinical Validation Study
A 180-patient randomised controlled trial confirmed NovaTear's superior efficacy vs. leading competitor carbomer gels in severe dry eye syndrome management.
Conley Carey Biomedical announces the successful completion of a 180-patient randomised controlled trial (RCT) evaluating the efficacy and safety of NovaTear Carbomer Gel 0.2% in severe dry eye disease.
The study, conducted across three ophthalmic centres in China and one in Germany over a 12-week treatment period, compared NovaTear to the market-leading carbomer gel using OSDI score, tear break-up time, and corneal fluorescein staining as endpoints.
- OSDI score reduction: NovaTear 41.3% vs. competitor 32.7% (p=0.014)
- TBUT improvement: +3.2 seconds NovaTear vs. +1.9 seconds competitor (p=0.031)
- Adverse event rate: 2.2% NovaTear vs. 4.4% competitor
- Patient preference at 12 weeks: 68% preferred NovaTear
The full data set has been submitted to a peer-reviewed ophthalmic journal and is currently under review. A preprint is available on request from medical@conleycarey.com.
"These results give us the clinical evidence to approach hospital procurement committees and ophthalmology KOLs with confidence," said Dr. Mei Zhang. "We are now preparing a European regulatory dossier for NovaTear as a Class IIa medical device."
