Improving Tolerance and Compliance with Topical Immunomodulators Using Micro-Emulsion Lipid Layer Artificial Tears

Figures & data

Table 1 Demographic Data of Study Patients

Parameters	Sex (%)			Mean Age (y) ± SD	P-value
	Male	Female	P-value
Medication used
Cyclosporine	27.3	72.7	0.547*	73.6 ± 4.2	0.137°
Lifitegrast	18.2	81.8		67.1 ± 5.9
Timing of Rohto use
Before	26.3	73.7	0.403*	69.7 ± 6.8	0.866°
After	14.3	85.7		69.0 ± 5.8
DED medication status
At-risk group	11.8	88.2	0.171*	69.7 ± 6.7	0.843°
Conversion group	31.2	68.8		68.9 ± 5.8

Notes: *Chi-squared test, °t-test. Demographic data demonstrates that there were no statistical differences between males and females with regard to which medication they used, the order in which they used the medication or if they had stopped using the medication previously. Also, there were no significant differences in age between subjects based on the aforementioned factors.

Figure 1 Change in VAS scores. Mean VAS score differences across all patients and between time points, pre-treatment vs 2–3 week (p<0.001); pre-treatment vs 1-day (p<0.001); 1-day vs 2–3 week (p= 0.028).

Table 2 VAS Score Sub-Analysis

Parameters	VAS Prescore ± SD	P-value	VAS at 1-Day ± SD	P-value	VAS at 2–3 Wks ± SD	P-value
Medication used
Cyclosporine	6.6 ± 1.3	0.573*	2.9 ± 1.5	0.926*	2.1 ± 1.7	0.388*
Lifitegrast	7.0 ± 0.7		3.0 ± 0.8		1.5 ± 0.7
DED medication status
At-risk group	6.5 ± 0.9	0.255*	2.7 ± 1.0	0.459*	1.0 ± 0.7	0.050*
Conversion group	7.2 ± 0.9		3.2 ± 1.1		2.3 ± 1.3
Timing of Rohto use
Before	6.7 ± 0.9	0.712*	3.2 ± 0.9	0.494*	1.8 ± 1.0	0.611*
After	7.0 ± 1.0		2.7 ± 1.2		1.5 ± 1.0

Notes: *t-test. Analysis demonstrates that VAS scores were significantly different at the 2–3 week timepoint in subjects who never stopped taking medication (at-risk group) versus those that did previously stop (conversion group). There was also a statistically significant improvement (p<0.001) in VAS scores from baseline to the 1-day and 2-3 week time points across all parameters, regardless of medical therapy, timing of Rohto use, or whether patients were in the at-risk versus conversion group.

Figure 2 VAS scores by subject group. VAS scores over time for subjects in the at-risk (A) and conversion (B) groups.

Table 3 Ingredients in Rohto Dry-Aid^†

Active	Povidone 0.68%, Propylene glycol 0.3%
Inactive	Boric acid, Menthol, Calcium chloride, Edetate disodium, Magnesium sulfate, PEG-10 castor oil, Poloxamer, Polyaminopropyl biguanide, Polyoxyl stearate, Purified water, Sesame oil, Sodium borate

Notes: ^†Ingredients reported from National Institutes of Health US National Library of Medicine.⁴²

ROHTO DRY-AID- povidone, propylene glycol liquid [Drug Information]. Available from: https://dailymed.nlm.nih.gov. Accessed June 11, 2020. Accessed May 19, 2020.

 Google Scholar