The short-term physiological impact of switching reusable silicone hydrogel wearers into a hydrogel daily disposable multifocal

Figures & data

Table 1 Subject demographics

		Hyperopes
	Completed	Total dispensed	Total not dispensed	Total enrolled
Gender n (%)
Female	13 (92.9)	13 (92.9)	1 (100)	14 (93.3)
Male	1 (7.1)	1 (7.1)	0 (0.0)	1 (6.7)
Age
n	14	14	1	15
Mean	57.6	57.6	57.0	57.6
Std	7.43	7.43	-	7.16
Median	58.0	58.0	57.0	58.0
Min	45.0	45.0	57.0	45.0
Max	67.0	67.0	57.0	67.0
		Myopes
	Completed	Total dispensed	Total not dispensed	Total enrolled
Gender n (%)
Female	19 (76.0)	19 (76.0)	2 (100)	21 (77.8)
Male	6 (24.0)	6 (24.0)	0 (0.0)	6 (22.2)
Age
n	25	25	2	27
Mean	52.8	52.8	58.0	53.2
Std	6.33	6.33	8.49	6.46
Median	51.0	51.0	58.0	52.0
Min	43.0	43.0	52.0	43.0
Max	65.0	65.0	64.0	65.0

Abbreviations: Std, standard deviation; Min, minimum; Max, maximum.

Table 2 Habitual contact lenses

Habitual SiHy contact lenses	Number of hyperopes	Number of myopes	Total # of subjects
Acuvue Oasys for Presbyopia	–	3	3
Acuvue Oasys with Hydraclear Plus	–	4	4
Air Optix Aqua	2	2	4
Air Optix Aqua Multifocal	5	4	9
Air Optix Night and Day Aqua	–	1	1
Biofinity Multifocal	2	4	6
Clariti 1 Day Multifocal	1	1	2
Dailies Total 1	–	1	1
PureVision	1	1	2
PureVision Multifocal	2	2	4
PureVision 2	–	1	1
PureVision 2 for Presbyopia	1	1	2
Total	14	25	39

Table 3 Study lens parameters

Name	1-Day Acuvue^® Moist^® Multifocal Brand (Spherical Lenses)
Manufacturer	Johnson & Johnson Vision
Lens material	etafilcon A
Nominal base curve mm (at 22°C)	8.40
Nominal diameter mm (at 22°C)	14.3
Distance powers (D)	+4.00 to −6.00 in 0.25 D steps
Add power	Low, Mid, High
Water content	58%
Nominal center thickness mm (at −3.00 D)	0.084
Oxygen transmissibility (Dk/t)	25.5
Modality	Daily disposable

Table 4 Least square (LS) mean difference estimates and 95% confidence intervals (CI) of corneal thickness (µm) along horizontal meridian measured with OCT

Location	Subject group	LS-Mean difference	StdErr	Lower CI	Upper CI	Non-inferiority Met?	Equivalence Met?
Central (0–2 mm)	Hyperopes	3.643	2.3281	−2.000	9.286	Yes	Yes
	Myopes	3.560	1.7422	−0.663	7.783	Yes	Yes
	Overall	3.601	1.4539	0.077	7.126	Yes	Yes
Peri-central (2–5 mm)	Hyperopes	3.571	1.8633	−0.402	7.545	Yes	Yes
	Myopes	3.920	1.3943	0.947	6.893	Yes	Yes
	Overall	3.746	1.1636	1.264	6.227	Yes	Yes
Transitional (5–7 mm)	Hyperopes	4.714	2.4698	−0.744	10.172	Yes	Yes
	Myopes	4.560	1.8482	0.476	8.644	Yes	Yes
	Overall	4.637	1.5424	1.229	8.046	Yes	Yes
Peripheral (7–10 mm)	Hyperopes	3.000	5.0689	−7.722	13.722	Yes	Yes
	Myopes	6.400	3.7933	−1.624	14.424	Yes	Yes
	Overall	4.700	3.1656	−1.996	11.396	Yes	Yes

Notes: Alpha level=0.05. Non-inferiority is established if the upper confidence limit is less than 30 microns. Equivalence is established if the upper and lower confidence limits are between ±30 microns.

Abbreviations: LS-Means, least-square means (Day 28 - baseline); StdErr, standard error; CI, confidence limits.

Figure 1 Open-eye corneal thickness (LS mean±CI) across the cornea (OCT) in hyperopes (top) and myopes (bottom) (overall values are not shown to prevent crowding).

Table 5 Least square (LS) mean difference estimates and 95% confidence intervals (CI) of objective bulbar and limbal hyperemia by Oculus K5M

Type	Subject group	Alpha level	LS-Mean difference	StdErr	Lower CI	Upper CI	Non-inferiority Met?	Equivalence Met?
Bulbar redness	Hyperopes	0.05	−0.081	0.0533	−0.186	0.024	Yes	Yes
	Myopes	0.05	0.042	0.0384	−0.033	0.118	Yes	Yes
	Overall	0.05	−0.019	0.0328	−0.084	0.046	Yes	Yes
Limbal redness	Hyperopes	0.05	−0.012	0.0533	−0.117	0.093	Yes	Yes
	Myopes	0.05	0.037	0.0384	−0.039	0.112	Yes	Yes
	Overall	0.05	0.012	0.0328	−0.052	0.077	Yes	Yes

Notes: Non-inferiority is established if the upper confidence limit is less than 1 grade. Equivalence is established if the upper and lower confidence limits are between ±1 grade.

Abbreviations: LS-Mean, least-square means (Day 28 - Baseline); StdErr, standard error; CI, confidence limits.

Table 6 Least square (LS) mean difference estimates and 95% confidence intervals (CI) of graded lid wiper epitheliopathy

	Subject group	Alpha level	LS-Mean difference	StdErr	Lower CI	Upper CI	Non-inferiority Met?	Equivalence Met?
LWE	Hyperopes	0.05	0.107	0.2430	−0.385	0.600	Yes	Yes
	Myopes	0.05	0.300	0.1819	−0.068	0.668	Yes	Yes
	Overall	0.05	0.204	0.1518	−0.104	0.511	Yes	Yes

Notes: Non-inferiority is established if the upper confidence limit is less than 1 grade. Equivalence is established if the upper and lower confidence limits are between ±1 grade.

Abbreviations: LS-Mean, least-square means (Day 28 - Baseline); StdErr, standard error; CI, confidence limits.

Figure 2 Open-eye objective (Oculus K5M) bulbar (top) and limbal (bottom) hyperemia (LS mean±CI).

Figure 3 Frequency (%) of graded mean corneal staining area (%).