Abstract
Purpose :
The NORTHERN LIGHTS study is a multicentre European study that assessed MC2-03 (CsA 0.03% and 0.06%) for the treatment of moderate-to-severe DED (objective was to evaluate safety and efficacy of MC2-03 after treatment for 6 months and a 3 month safety follow-up compared to vehicle and hypromellose lubricant once daily).
Methods :
The NORTHERN LIGHTS study is a randomized, double masked, 4 arm controlled multicentre European study that assessed MC2-03 (CsA 0.03% and 0.06%) for the treatment of moderate-to-severe DED. Candidates are evaluated for eligibility at a Screening Visit and, approximately 2 weeks later, a Baseline visit at more than 30 clinical centers across Europe. To qualify for the study, adult patients must have a corneal fluorescein staining (CFS) score ≥3 on the modified Oxford scale and global discomfort score ≥30. Each symptom was assessed using a Visual Analogue Scale (0-100) where 0% = no discomfort and 100% = maximal discomfort. The global VAS assessment of global discomfort was the average of 4 relevant symptoms: eye dryness, burning/stinging, pain and foreign body sensation. Symptoms were assessed in each eye.
Results :
263 patients were randomised. The overall mean age was 61.15 years (range 23 to 90 years), with 91% of the patients being females (n=232) of which a vast majority were post-menopausal.
57.6% of the patients had CFS 3 at baseline (n=147) compared to 42.4% with CFS 4 (n=108). In DED patients, punctate staining of the cornea is not normal and the presence of punctuate staining suggests the loss of epithelial cell membrane or junctional integrity. The modified Oxford grading system, a 7-point ordinal scale (0, 0.5, and 1 to 5), was used to evaluate CFS in this clinical study. In this system a grade 0 represents complete corneal clearing (absence of staining dots).
Mean VAS assessment score at baseline was 64.7. Looking at each of the 4 relevant symptoms assessed for patients enrolled, eye dryness had the highest score (> 73 for both eyes) and pain the lowest score (< 55 for both eyes).
A total of 25.9% of the patients had Sjögren’s syndrome (n=66). Among this specific group of patients, 58% had a CFS 4 at baseline (n=38).
Conclusions :
The NORTHERN LIGHTS study shows a typical distribution for the patients enrolled in the study.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.