Comparative Efficacy of Lipid-Based vs. Aqueous-Based Artificial Tears in the Management of Evaporative Dry Eye: A Randomized Clinical Trial
DOI:
https://doi.org/10.71000/f57ncw09Keywords:
Artificial Tear,Dry Eye Disease,Evaporative Dry EyeAbstract
Purpose: This clinical trial aimed to determine whether a lipid-based artificial tear (Recuro) or an aqueous-based artificial tear (Softear) is more effective in alleviating symptoms of Evaporative Dry Eye (EDE).
Methods: This double-blind RCT was conducted at Mughal Eye Hospital, Lahore. Sample size (60 subjects, 30 subjects per group) was determined through G*Power. Subjects (18-55 years, all genders) received Recuro or Softear for 6 weeks, with allocation using block randomization (block size 4) done through Research Randomizer. The primary outcomes were the OSDI (Ocular Surface Disease Index) and the SANDE (Symptom Assessment in Dry Eye). The secondary outcomes were TBUT (Tear Break-Up Time), Schirmer's test I, and Meibomian gland expression.
Results: Data were processed using SPSS-23. Within and intergroup comparisons were done using paired and independent sample t-tests, respectively. The Recuro group achieved a greater mean reduction in OSDI (50.50 vs 30.43, p<0.001) and in SANDE scores (40.95 vs 32.63, p=0.037) compared to the Softear group. The Recuro group also demonstrated greater mean increments in TBUT (4.75 vs 3.92, p<0.001), Schirmer's test (6.16 vs 4.08, p<0.001), and Meibomian gland expression in both right (mean reduction: 5.48 vs 2.32, p<0.001) and left eyes (mean reduction: 6.02 vs 2.26, p<0.001). Both treatments were well-tolerated.
Conclusion: The P value analysis indicated statistical significance at less than 0.05, which demonstrates that Recuro artificial tears are more effective than Softeal tears in alleviating subjective and objective indicators of EDE.
Registration No: NCT06913387
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