Procedures
hyperemia, petechiae, conjunctival blood vessels
ADVERSE EVENTS, HYPEREMIA, CORNEA, PETECHIAE, LENS, SUBCONJUNCTIVAL HEMORRHAGE, CONJUNCTIVA
Once enrolled, participants were randomly assigned 1:1 to either NET/LAT or comparator BIM/TIM, both administered as one drop, once daily (QD) in both eyes in the evening between 20:00 and 22:00 h. Treatment continued with either NET/LAT or BIM/TIM for approximately 180 days (the safety endpoint). IOP measurements were taken at 08:00, 10:00, and 16:00 h at baseline and at Week 2 (Day 15), Week 6 (Day 43), and Month 3 (Day 90) using Goldmann applanation tonometry. One eye was termed the 'study' eye and the other the 'fellow eye'. The study eye was the eye with the higher IOP at 08:00 h on Visit 3; if both eyes had the same IOP at this visit, then the right eye was determined the study eye. Only the IOP values measured in the study eye were evaluated for efficacy. In each patient, both eyes received the study medication.At each study visit, assessments were conducted for some or all of the following: systemic safety (heart rate, blood pressure and clinical laboratory evaluations, including hematology and clinical chemistry), pregnancy testing (for women of childbearing potential), ETDRS corrected visual acuity, objective findings of biomicroscopic evaluations (i.e., anterior segment evaluations including evaluation of cornea, conjunctiva, lids and lens), cup-to-disc ratio measurements, dilated ophthalmoscopic examination, quality of life assessments (NEI VFQ-25 and SF-36), and ocular symptoms and adverse events (AEs). Visual field testing was performed at screening, Month 3, and Month 6. For participants who discontinued treatment, every possible effort was made to conduct a final visit that included all study visit examinations at Month 6. Biomicroscopic grading of conjunctival hyperemia was performed on a standardized, 4-point scale: 0 = none (normal; appears white with a small number of conjunctival blood vessels easily observed); 1 = mild (prominent pinkish-red colour of both the bulbar and palpebral conjunctiva); 2 = moderate (bright, scarlet red colour of the bulbar and palpebral conjunctiva); 3 = severe (“beefy red” with petechiae; dark red bulbar and palpebral conjunctiva with evidence of subconjunctival hemorrhage) [