Safety and Efficacy of a Polyethylene Glycol/Propylene Glycol Based Lubricant Eye Drop in Patients with Dry Eye

• Published in: Acta ophthalmologica (Oxford, England) England), 2015-10, Vol.93 (S255), p.n/a
• Main Authors: Labetoulle, M., Messmer, E., Ogundele, A., Mouriaux, F., Baudouin, C.
• Format: Article
• Language: English
• Subjects: Ophthalmology
• ISSN: 1755-375X; 1755-3768
• DOI: 10.1111/j.1755-3768.2015.0495

Purpose The objective of this study was to compare the efficacy and safety of a polyethylene glycol/propylene glycol based eye drop (PEG/PG; Systane® Ultra) to an osmoprotective‐carboxymethylcellulose based eye drop (CMC/O; Optive®) in patients with dry eye. Methods This was a multicenter, observer masked, parallel‐design study, subjects were randomized to PEG/PG or CMC/O QID for 35 days (Phase 1) and then as needed for 55 days (Phase 2). Eligible subjects were diagnosed with dry eye and exhibited signs and symptoms at screening. Supportive efficacy assessments included the total ocular staining score (TOSS) score change from baseline to Day 90 (15‐point Oxford scale). Results Demographic characteristics were similar between the PEG/PG (n = 46) and CMC/O groups (n = 48). The efficacy of PEG/PG was similar to CMC/O at Day 90 (LS mean treatment difference in TOSS score change from baseline to Day 90 of −0.10 units in favor of PEG/PG). In addition, ocular surface staining associated with dry eye decreased following treatment with PEG/PG with a mean TOSS score change from baseline at Day 90 of −2.7 units. No treatment‐related serious adverse events were reported. Five subjects discontinued due to treatment‐related AEs (2 PEG/PG and 3 CMC/O subjects). Conclusions PEG/PG based drop demonstrated comparable efficacy to the CMC/O based drop after 90 days treatment with a favorable safety profile in patients with dry eye.