primary outcome:
Topical cyclosporine A therapy for dry eye syndrome
Our primary outcome was improvement of dry eye symptoms such as dryness, scratchiness, foreign body sensation, and burning at six months follow‐up, measured by patient questionnaires or clinician‐based assessments.Thirteen trials (involving 1556 participants) evaluated subjective symptoms of dry eye (Section 1 of Figure 9). The outcomes were reported as final mean score, mean change from baseline, or number of participants who improved the symptom. Only one trial, Rao 2010, reported sufficient data to permit calculation of a between‐group difference (mean difference (MD) −4.80, 95% confidence interval (CI) −6.41 to −3.19); this difference was in favor of CsA 0.05%. The remaining 12 trials had deficiencies in reporting (e.g. reporting P value or direction only), precluding the calculation of between‐group estimates of effect or meta‐analysis. The certainty of evidence was low, downgraded for risk of bias (−1) and imprecision (−1) summary of findings Table for the main comparison.Three trials (involving 1059 participants) evaluated subjective symptoms of dry eye (Section 1 of Figure 10). These trials reported P value or direction of effect only, thus we were unable to calculate between‐group effect estimate or perform a meta‐analysis.All four trials (involving 176 participants) used the Ocular Surface Disease Index (OSDI) to evaluate the symptoms of dry eye (Section 1 of Figure 12). These trials reported P value or direction of effect only, thus we were unable to calculate between‐group effect estimate or perform a meta‐analysis.Both trials (involving 105 participants) evaluated patient‐reported symptoms, but the results were reported as P value or direction of effect only (Section 1 of Figure 13). We were not able to calculate between‐group effect estimate or perform a meta‐analysis.Subjective symptoms of dry eye were assessed using the OSDI, visual analogue scale (VAS) of ocular discomfort, investigator global evaluations of efficacy, and National Eye Institute Visual Function Questionnaire (NEI‐VFQ‐25). Sufficient data were provided to combine these two trials in mean change in ocular discomfort at month 6 (Section 1 of Figure 14). Summary estimate showed a non‐statistically significant mean difference of −1.96 (95% CI −4.94 to 1.02) (Analysis 3.1; Figure 15). In Leonardi 2016, the proportion of participants who showed improvement in OSDI or VAS ≧ 30% was similar in both groups (RR 1.0, 95% CI 0.73 to 1.38 in OSDI; RR 0.83, 95% CI 0.59 to 1.19 in VAS). There were no significant between‐group differences in the mean change from baseline in OSDI score (MD −1.1, 95% CI −6.39 to 4.19) or NEI‐VFQ‐25 (MD 0.4, 95% CI −3.11 to 3.91). We downgraded the quality of evidence from high to moderate because details of masking were not clearly reported regarding these subjective outcomes.Two trials (involving 59 participants) reported subjective symptoms (Section 1 of Figure 18). These trials reported direction of effect only, thus we were unable to calculate between‐group effect estimate or perform a meta‐analysis.One trial (involving 30 participants) reported symptoms of dry eye in direction of effect only, thus we were unable to calculate between‐group effect estimate (Section 1 of Figure 19).