A preservative-free artificial tear formulation was associated with reduced ocular dryness symptoms after 1 month of use in a prospective, multicenter study conducted in Spain, although the study did not include a control group.
Researchers evaluated Systane Complete Preservative-Free eye drops (Alcon) in adults aged 18 to 65 years with mild to moderate ocular dryness symptoms, defined by Ocular Surface Disease Index (OSDI) scores of 13 to 32. Patients used the drops four times daily—on waking, at midday, in the afternoon, and about 2 hours before bedtime—for 4 weeks.
Among 101 enrolled patients, 86 completed baseline and final visits (mean age, 43 years; 78% women). Symptom scores improved throughout the study. Mean OSDI scores decreased from 23 at baseline to 8 at 1 month, while 5-Item Dry Eye Questionnaire (DEQ-5) scores declined from 10 to 4. Improvements were observed at each weekly assessment and were most pronounced at the final visit.
Subgroup analyses showed similar symptom improvement across age groups, although reductions in DEQ-5 scores plateaued at later visits among patients aged 46 to 65 years. The correlation between OSDI and DEQ-5 scores strengthened over time, increasing from 0.42 at baseline to 0.78 at study end.
Objective signs also improved. Mean conjunctival hyperemia scores decreased from 0.99 to 0.59, and limbal hyperemia from 0.74 to 0.36. The proportion of patients without conjunctival hyperemia increased from 22% to 39%, and those without limbal hyperemia from 32% to 56%. Improvements were also observed in blepharitis, meibomian gland dysfunction, and conjunctival staining. Corneal staining improved on the Oxford scale but not significantly on the Efron scale.
Exploratory analyses assessed associations between environmental conditions and clinical findings. At baseline, DEQ-5 scores and the environmental subscale of the OSDI were associated with sulfur dioxide levels, while no correlation was observed with total OSDI scores. At the final visit, DEQ-5 scores were associated with multiple environmental factors, including sulfur dioxide, ozone, nitric oxide, nitrogen dioxide, and wind speed. Associations between Efron scale findings and environmental variables also varied between visits. The authors noted that these findings were exploratory and should be interpreted cautiously.
The study had several limitations, including the absence of a control group, a short follow-up period, and a predominance of women in the sample. Environmental analyses were also based on relatively small sample sizes.
After 1 month of treatment, questionnaire scores decreased by approximately 50%, which the researchers attributed to improved tear film stability.
Disclosures: The study was partially funded by an Alcon Investigator Initiated Trial; researchers reported no conflicts of interest.
Source: Journal of Optometry
