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ORIGINAL RESEARCH

Cyclosporine A (0.05%) Ophthalmic Gel in the Treatment of Dry Eye Disease: A Multicenter, Randomized, Double-Masked, Phase III, COSMO Trial

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Pages 3183-3194 | Received 10 May 2022, Accepted 30 Aug 2022, Published online: 05 Dec 2023

Figures & data

Table 1 Baseline Characteristics of the Participants

Figure 1 Study flowchart.

Abbreviations: SS, safety set; FAS, full analysis set.
Figure 1 Study flowchart.

Figure 2 The proportion of subjects with at least a 1-point improvement in ICSS from baseline at day 14, 42, and 84 in the CyclAGel (n=315) and vehicle (n=312) groups. * P<0.025; ** P<0.0001.

Abbreviations: ICSS, inferior corneal staining score; NR/LOCF, not reached/last observation carried forward.
Figure 2 The proportion of subjects with at least a 1-point improvement in ICSS from baseline at day 14, 42, and 84 in the CyclAGel (n=315) and vehicle (n=312) groups. * P<0.025; ** P<0.0001.

Figure 3 Subgroup analyses for the proportion of subjects with at least a 1-point improvement in ICSSat day 84 from baseline. The squares represent the mean value, and the lines represent the 95% CI. Differences between groups with 95% CI including 0% are considered not statistically significant.

Abbreviations: CI, confidence interval; ICSS, inferior corneal staining score.
Figure 3 Subgroup analyses for the proportion of subjects with at least a 1-point improvement in ICSSat day 84 from baseline. The squares represent the mean value, and the lines represent the 95% CI. Differences between groups with 95% CI including 0% are considered not statistically significant.

Table 2 Changes from Baseline in DED Signs of the Study Eye at Days 14, 42, and 84

Table 3 Changes in Binocular Symptom Scores from Baseline at Days 14, 42, and 84

Figure 4 Changes from baseline in DED signs of the study eye at day 14, 42, and 84 in the CyclAGel (n=315) and vehicle (n=312) groups. (A) Inferior corneal staining score (ICSS); (B) Oxford scale scoring of corneal and conjunctival fluorescein staining; (C) break-up time (BUT); (D) Schirmer tear test. * P<0.05. ** P<0.01.

Figure 4 Changes from baseline in DED signs of the study eye at day 14, 42, and 84 in the CyclAGel (n=315) and vehicle (n=312) groups. (A) Inferior corneal staining score (ICSS); (B) Oxford scale scoring of corneal and conjunctival fluorescein staining; (C) break-up time (BUT); (D) Schirmer tear test. * P<0.05. ** P<0.01.

Table 4 Incidence of Treatment-Emergent Adverse Events (TEAEs)