Table 3.
Ocular surface assessments and outcomes.
| Author (Year) | Evaluation on ocular surface performed | Outcomes |
|---|---|---|
| Rossi et al. [32] | TBUT | The median value changed from 8 s at baseline to 10 s at the 6-month visit (P = 0.0001). |
| Hyperaemia score | No significant difference was noted between BAK and PQ. | |
| OSS | Punctate keratitis was observed in 70.5% of patients at baseline, and it decreased to 29.5% after 6 months (P < 0.001). | |
| Lopes et al. [33] | Hyperaemia score | Hyperaemia score decreased from 0.94 to 0.74. |
| Walimbe et al. [34] | TBUT | The TBUT significantly improved from 3.67 ± 1.60 s at baseline to 6.06 ± 3.39 s after 56 days of PF-LT treatment (P = 0.0001). |
| Hyperaemia score | The mean value was 0.48 ± 0.75 at baseline for PC-LT and decreased to 0.35 ± 0.48 with PF; this decrease was not statistically significant. | |
| Inferior corneal staining | The values for corneal staining significantly decreased from 0.85 ± 0.69 to 0.53 ± 0.60 after 56 days with PF-LT (P = 0.0033). | |
| Moussa et al. [35] | Hyperaemia score | Signs were found in all four (PC-BM, PC-LT, PQ-TV, and PF-TF) groups, although no significant difference was found between them. |
| OSS (Oxford scale) | Signs were found in all four (PC-BM, PC-LT, PQ-TV, and PF-TF) groups, although no significant difference was found between them. | |
| Rahmatnejad et al. [36] | Schirmer test | Better results were found for PC (SofZia) TV, although there was no significant difference between groups. |
| TBUT | During follow-up, patients already treated showed worse results (P = 0.002), although no significant difference was observed at the 2-month follow-up. | |
| Hyperaemia score | No significant difference was observed between eyes (BAK-preserved LT and SofZia-preserved TV) or between groups 1 and 2. | |
| OSS | No significant difference was found within groups for conjunctival or corneal staining. | |
| Wong et al. [37] | TBUT | Significant increase was observed after 1 (P = 0.003) and 3 (P = 0.017) months. |
| Hyperaemia score | Substantial reductions in hyperaemia score for both bulbar conjunctiva (P = 0.028) and palpebral conjunctiva (P = 0.001) were noted. | |
| OSS | All individual areas had a significant decrease compared to baseline (P < 0.05). | |
| Diagourtas et al. [38] | TBUT | The overall mean value decreased between baseline and final visits. No statistically significant difference was found among formulations. |
| Kumar et al. [20] | TBUT | The TBUT decreased during follow-up for both groups. Lower values were observed for the PC group (P < 0.043). |
| Hyperaemia score | After 2 weeks of treatment, significant values (P = 0.025) were found between both (PC-LT vs PF-LT) groups. No significant difference was found after the 12-week follow-up. | |
| Lee et al. [42] | Schirmer test | Significant difference was found between PGA users and those in the control group (P < 0.001). Better results were obtained in the control group. |
| TBUT | Significant difference was found between PGA users and those in the control group (P < 0.001). Better results were obtained in the control group. | |
| KEP | Significant difference was found between PGA users and those in the control group (P = 0.015). Better results were obtained in the control group. | |
| MG parameters | All parameters showed significant difference (P < 0.001). Better results were obtained in the control group. | |
| Zaleska-Żmijewska et al. [16] | Schirmer test | Schirmer test showed a significant difference between groups: preservative-containing medication (8.27 mm/5 min) and preservative-free medication (12.07 mm/5 min), and control (11.63 mm/5 min) (P < 0.05). |
| TBUT | The TBUT test results correlate with MMP-9 measures. Fifty percent of participants using BAK-containing medication and 10% of those receiving preservative-free treatment and those in the control group achieved a TBUT of <5 s (P < 0.05). | |
| OSS (Oxford scale) | Increased corneal and conjunctival staining in the BAK-containing group compared with untreated or preservative-free users | |
| Misiuk-Hojlo et al. [17] | TBUT | The TBUT significantly improved compared with that at baseline in 23.4% of patients at day 45 (D45) and in 30.7% of patients at day 90 (D90) (P = 0.0023 and P < 0.0001, respectively). |
| Hyperaemia (McMonnies scale) | Conjunctival hyperaemia decreased progressively, with 1.6% of patients having it at D90 (P < 0.0001). | |
| OSS (Oxford scale) | Conjunctival fluorescein staining showed marked improvement, with 3.2% of patients showing it at D90 (P < 0.0001). Corneal fluorescein staining significantly improved, with no staining in 90.3% of patients at D90 (P = 0.0001). | |
| Blepharitis | Blepharitis prevalence decreased significantly, with 0.8% of patients showing it at D90 (P < 0.0001). | |
| Lopes et al. [18] | Schirmer test | Schirmer test mean score of 5.09 ± 2.75 mm decreased to 4.36 ± 2.40 mm (P = 0.198, not statistically significant). |
| BUT (DEWS) | TF-BUT mean score of 6.68 ± 2.07 s decreased to 5.5 ± 2.15 s (P = 0.113, not statistically significant). | |
| GL test (Bijsterveld’s scale) | GL test (Bijsterveld index) mean score of 6.27 ± 2.72 decreased to 3.04 ± 1.25 (P < 0.001, statistically significant improvement). | |
| Kumar et al. [19] | Not performed | |
| El Ameen et al. [22] | BUT (K5M) | The text does not provide specific numerical values or P values for break-up time (BUT). Therefore, it is not possible to determine the exact changes in BUT or whether there were statistically significant differences among the treatment groups based on the information provided. |
| Conjunctival hyperaemia: limbal+bulbar (K5M) | Bulbar+limbal hyperaemia was significantly different when results from PC users when compared with those from PF-LT users. | |
| TMH (K5M) | The text mentions that there were no relevant between-group differences in the mean TMH. This suggests that the different treatments did not significantly affect tear meniscus height. | |
| Ha et al. [23] | Schirmer test | No significant difference was observed between groups (PC-PGA, PF-PGA, and control) |
| TBUT | Significant differences were found when comparing PC-PGA vs PF-PGA (P = 0.012) and PC-PGA vs control (P = 0.001). | |
| OSS (Oxford scale) | All groups showed significant differences between them: PC-PGA vs PF-PGA (P = 0.021); PC-PGA vs control (P = 0.001), and PF-PGA vs control (P = 0.001). | |
| Meibomian gland dropout (K5M) | No significant difference in MG dropout between groups. | |
| Meibum score | All groups showed significant differences between them: PC-PGA vs PF-PGA (P = 0.007); PC-PGA vs control (P = 0.001); and PF-PGA vs control (P = 0.031). | |
| Meibo-score | All groups showed significant differences between them: PC-PGA vs PF-PGA (P = 0.035); PC-PGA vs control (P = 0.001); and PF-PGA vs control (P = 0.027). | |
| Lid margin abnormality | Significant difference was found in PC-PGA vs PF-PGA and PC-PGA vs control (P = 0.015 and P = 0.021, respectively). No significant difference was found between PF-PGA and control. | |
| Lee et al. (2019) | Schirmer test | No statistically significant difference between the four TF groups. |
| TBUT | Significant differences between 24-month PF-TF and 24-month PC-TF users (P = 0.022) | |
| OSS (Oxford scale) | No statistically significant differences between the four TF groups | |
| MG dropout rate (LipiView II) | Significant differences between 6-month PF-TF and 24-month PC-TF and 24-month PF-TF users. There were also significant differences between 6-month PC-TF and 24-month PC-TF and 24-month PF-TF users. There were significant differences between 24-month PF-TF and 24-month PC-TF users. | |
| Lid margin abnormality | Significant differences between the 6-month PF-TF and 24-month PC-TF groups (P = 0.048) | |
| Meibum quality | No statistically significant difference between the four TF groups | |
| Meibum expressibility | Significant differences between the 6-month PF-TF and 24-month PC-TF groups (P = 0.022) | |
| Meiboscale | Significant differences between the 6-month PF-TF and 24-month PF-TF and 24-month PC-TF groups. There were significant differences between the 6-month PC-TF and 24-month PC-TF and 24-month PF-TF groups. There were significant differences between the 24-month PF-TF and 24-month PC-TF groups. | |
| Sedlak et al. [25] | TP concentration | The TP concentration was higher in PC-LT, but only significant when compared with the control group (P < 0.001). The PF-LT group had a significantly higher TP level than the control group (P < 0.01). The TP value for the PC-BM group was significantly higher compared with the control group (P < 0.001), although no significant differences were noted when compared with the PF-LT and PC-LT groups. |
| Activity of superoxide dismutase | No significant differences between the control, PF-LT, and PF-TF groups. In the groups using PC medication, the results were significantly higher than in the control group (P < 0.001). | |
| Catalase | No significant differences between the control, PF-LT, and PF-TF groups. In the groups using PC medication, the results were significantly higher than in the control group (PC-LT, P < 0.5; PC-BM, P < 0.1). | |
| Glutathione peroxidase | There were statistically significant differences between the preservative-containing and preservative-free groups. Any of the groups showed significant differences in glutathione peroxidase activity when compared with the control group. | |
| Advanced oxidation protein products content | All the study groups showed significantly higher values than the control group (PF-LT, P < 0.05; PC-LT, P < 0.01; PF-TF, P < 0.01; PC-BM, P < 0.01). No significant difference between the medication groups. | |
| Total sulfhydryl | All the study groups showed significantly lower results than the control group (PF-LT, P < 0.05; PC-LT, P < 0.01; PF-TF, P < 0.05; PC-BM, P < 0.05). No significant differences between the medication groups. | |
| Total oxidant status | When compared with control, all groups showed higher results (PF-LT, P < 0.01; PC-LT, P < 0.001; PF-TF, P < 0.001; PC-BM, P < 0.001). | |
| Total antioxidant response | No significantly different results were found between the study and control groups. | |
| Oxidative stress index | Only patients using PF-LT obtained significantly higher results when compared with controls; for the rest, the results were as follows: PC-LT, P < 0.001; PF-TF, P < 0.01; PC-BM, P < 0.05. | |
| Kumar et al. [21] | Not performed | |
| Ruangvaravate et al. [26] | Schirmer test | The test results showed minimal improvement in the PF-TF group, with no statistically significant difference from baseline. There was also no statistically significant difference in clinical sign test results between the PC-TF and PF-TF groups. |
| TBUT | Significant increase in both groups at week 24 (PF-TF, P = 0.002; PC-TF, P = 0.004) | |
| OSS (Oxford score) | No significant difference was found when compared with baseline values or when compared between groups | |
| Conjunctival hyperaemia | No significant difference was found when compared with baseline values or when compared between groups | |
| Lid inflammation | No significant difference was found when compared with baseline values or when compared between groups | |
| Guo et al. [27] | Meibomian gland dropout (K5M) | MGL increased significantly at 9 and 12 months in the PC-PGA group (P < 0.001). No significant differences in MGL were found in the PF-PGA and PC-PGA + DQS groups at 9 or 12 months. |
| Erb et al. [28] | TBUT | Lower than 5 s for 10.8% and lower than 10 s for 52.3% of the eyes |
| OSS | No statistical difference between the individual therapy groups. The results were slightly better in treatment-naïve patients. | |
| Conjunctival hyperaemia | No statistical difference between the individual therapy groups. The results were slightly better in treatment-naïve patients. | |
| OSD | Lid redness was the most common ocular sign among patients with OSD. The different ocular surface parameters showed no statistically significant difference between patients. | |
| Hagras et al. [29] | TBUT | The TBUT significantly worsened after PC-LT at 2 and 5 months (P < 0.001 and P = 0.026, respectively), but remained nonsignificant after PF-TF treatment. |
| Conjunctival hyperaemia | Significantly higher in PC-LT-treated eyes | |
| Corneal erosion | Significantly higher in PC-LT-treated eyes | |
| Seong et al. [30] | TBUT | Results when switching to PF-LT after 90 days were not significant (P = 0.369). |
| OSS | Significant differences were found in corneal and conjunctival staining after 90 days, with an improvement of P < 0.001 and P = 0.02, respectively. | |
| Hyperaemia: Bulbar injection+Limbal injection | Results for hyperaemia improved with both bulbar and limbal injections, although only bulbar injection obtained significant results (P = 0.025). | |
| Muz et al. [31] | Schirmer test | The results were better for PQ-preserved TV treatment with significant differences compared to BAK-preserved LT at baseline (P = 0.014) and also after 12 months (P = 0.015). |
| TBUT | The results were better for PQ-preserved TV treatment compared to BAK-preserved LT, but they were not significant after 12 months (P = 0.475). | |
| OSS (Oxford scale) | The results were similar with both medications, and the results were not significant. | |
| Wu et al. [41] | Schirmer test | After 4 months, the results between the PF-BM and PC-LT groups were not clinically significant (P = 0.0529). |
| NIKBUT (K5M) | Comparing the average NIKBUT after 4 months, the results were not clinically significant (P = 0.7749). | |
| OSS (Oxford scale) | After 4 months, the results between the PF-BM and PC-LT groups were not clinically significant (P = 0.5897). | |
| Conjunctival redness or hyperaemia score (R score) (K5M) | After 4 months, the results between the PF-BM and PC-LT groups for limbal temporal and bulbar temporal hyperaemia were not clinically significant (P = 0.1751 and P = 0.3309, respectively). Limbal nasal and bulbar nasal hyperaemia value compared between the PF-BM and PC-LT groups was clinically significant, with better results for the PF-BM group (P = 0.0035 and P = 0.0068, respectively). | |
| TMH (K5M) | The results were not significant between the PF-BM and PC-LT groups after 4 months (P = 0.4663). | |
| Kim et al. [39] | TBUT | The values decreased in both groups during the visits, although the results between them were not clinically significant (P = 0.458 at visit 4). |
| OSS (Oxford scale) | The values were similar in both groups at visit 3. No clinically significant results were obtained when the groups were compared (P = 0.399 for corneal staining; P = 0.292 for conjunctival staining). | |
| Hyperaemia value (Efron scale) | Only the bulbar hyperaemia value of the PF group at 12 weeks was significantly lower than that of the PC group (P = 0.037). | |
| Kim et al. [40] | TBUT | No significant difference between the PF-LT, PC-LT, and PF-TF groups at study completion. |
| OSS | There were significant differences with lower results in the PF-LT group alone. The results in the PF-TF and PC-LT groups remain the same, with no significant changes. | |
| Hyperaemia score | No significant differences between the PF-LT, PC-LT, and PF-TF groups at study completion. |
ANOVA analysis of variance, BAK benzalkonium chloride, BM bimatoprost, BUT break up time, DEWS dry eye workshop, GL green lisamine, K5M keratograph 5M, LT latanoprost, MG meibomian gland, MGL meibomian gland loss, NIKBUT not invasive break up time, OSD ocular surface disease, OSS ocular surface staining, PC preservative-container, PGA prostaglandin analogue, PF preservative-free, PQ polyquad, TBUT tear break up time, TMH tear meniscus height, TV travoprost, TF tafluprost, TP total protein, TF-BUT tear film break-up time, KEP keratoepitheliopathy.