METHODS: In this randomized, double-blind interventional study, diabetics with DED aged 18 to 60 years were randomly assigned to TI or standard artificial tears (SAT). Baseline Ocular Surface Disease Index (OSDI), Schirmer I test (ST), tear break-up time (TBUT), and ocular Sjögren's International Collaborative Clinical Alliance (SICCA) score were compared 4 weeks after treatment.
RESULTS: A total of 160 participants (involving 320 eyes) received either TI (n=80) or SAT (n=80). After 4 weeks of treatment, a significant number of participants in both TI and SAT groups showed improvement in their OSDI score, 66% and 63%, respectively (P=0.0001), but were not significantly better than each other (P=0.453). However, most participants in both groups showed worsening of ST and TBUT (P>0.05). Most of the participants in both groups showed no change in their ocular SICCA score (P>0.05).
CONCLUSION: The study has shown a significant and similar improvement in the OSDI score for TI 1 unit/drop four times daily and SAT in treating diabetics with DED. Further research is required to understand the long-term effects of TI on the ocular surface.