Clinical Performance of Samfilcon A, a Unique Silicone Hydrogel Lens, on a 7-Day Extended Wear Basis

Figures & data

Table 1 Demographics of Eligible Dispensed Subjects

Characteristic	Samfilcon A (n = 403)	Balafilcon A (n = 402)	p-value
Age (years)
Mean ± SD	29.8 ± 6.2	29.2 ± 6.1	0.17^#
Gender: n (%)
Female	263 (65.3)	265 (65.9)	0.84^§
Male	140 (34.7)	137 (34.1)
Race: n (%)
White	326 (80.9)	328 (81.6)	0.63^§
Black/African American	33 (8.2)	30 (7.5)
Asian	15 (3.7)	19 (4.7)
Other	25 (6.2)	18 (4.5)
Refused to Answer	4 (1.0)	7 (1.7)

Notes: ^§Between-group p-value comparing category proportions based on chi-squared test. The test for race excluded subjects that refused to answer. ^#Between-group p-value comparing mean scores based on two-sample t-test.

Figure 1 Subject enrollment flow chart.

Table 2 Graded Slit Lamp Findings Over All Follow-Up Visits

Finding	Lens Group	Grade 0	Grade 1	Grade 2	Grade 3	Grade 4
		Number of Eyes (% of Eyes)
Epithelial Edema	Samfilcon A	5470 (99.5)	19 (0.35)	6 (0.11)	0 (0)	0 (0)
	Balafilcon A	5358 (99.4)	28 (0.52)	5 (0.09)	0 (0)	0 (0)
Epithelial Microcysts	Samfilcon A	5481 (99.8)	14 (0.25)	0 (0)	0 (0)	0 (0)
	Balafilcon A	5371 (99.6)	19 (0.35)	1 (0.02)	0 (0)	0 (0)
Limbal Injection	Samfilcon A	5154 (93.8)	314 (5.7)	20 (0.36)	7 (0.13)	0 (0)
	Balafilcon A	5027 (93.3)	345 (6.4)	12 (0.22)	7 (0.13)	0 (0)
Bulbar Injection	Samfilcon A	5019 (91.3)	434 (7.9)	34 (0.62)	8 (0.15)	0 (0)
	Balafilcon A	4922 (91.3)	437 (8.1)	26 (0.48)	6 (0.11)	0 (0)
Corneal Infiltrates	Samfilcon A	5459 (99.3)	19 (0.35)	13 (0.24)	3 (0.05)	1 (0.02)
	Balafilcon A	5378 (99.8)	7 (0.13)	4 (0.07)	2 (0.04)	0 (0)
Corneal Neovascularization	Samfilcon A	5349 (97.3)	146 (2.7)	0 (0)	0 (0)	0 (0)
	Balafilcon A	5229 (97.0)	162 (3.0)	0 (0)	0 (0)	0 (0)
Upper Lid Tarsal Conjunctival Abnormalities	Samfilcon A	4197 (76.4)	1204 (21.9)	80 (1.46)	12 (0.22)	2 (0.04)
	Balafilcon A	3945 (73.2)	1336 (24.8)	103 (1.91)	6 (0.11)	1 (0.02)
Corneal Staining	Samfilcon A	3781 (79.9)	918 (19.4)	30 (0.63)	6 (0.13)	0 (0)
	Balafilcon A	3523 (76.0)	1021 (22.0)	89 (1.92)	3 (0.06)	0 (0)

Note: Distribution is based on all individual follow-up eye visits (including both OD and OS) for all subjects.

Table 3 Subject-Wise Slit Lamp Findings Grade 2 or Greater Over All Follow-Up Visits

Finding	Number (Percent) of Subjects with Grade 2 or Greater Finding on Either Eye on at Least One Follow-Up Visit		^†,*p-value
	Samfilcon A (n = 402)	Balafilcon A (n = 400)
Epithelial Edema	4 (1.0)	4 (1.0)	> 0.99
Epithelial Microcysts	0 (0)	1 (0.3)	0.50
Limbal Injection	21 (5.2)	14 (3.5)	0.30
Bulbar Injection	33 (8.2)	23 (5.8)	0.21
Corneal Infiltrates	12 (3.0)	4 (1.0)	0.07
Corneal Neovascularization	0 (0)	0 (0)	NA
Upper Lid Tarsal Conjunctival Abnormalities	27 (6.7)	39 (9.8)	0.12
Corneal Staining^#	27 (6.7)	46 (11.6)	0.02*

Notes: ^†Between-treatment p-value comparing proportions based on Fisher’s exact test. ^#n = 401 for samfilcon A and 397 for balafilcon A for this parameter only. *Difference deemed significant at p < 0.05.

Abbreviation: NA, not applicable.

Table 4 Subject-Wise Ungraded Slit Lamp Findings Over All Follow-Up Visits

Finding	Number (Percent) of Subjects with Finding on Either Eye on At Least One Follow-up Visit		^†,*p-value
	Samfilcon A (n = 402)	Balafilcon A (n = 400)
New Corneal Scars	8 (2.0)	2 (0.5)	0.11
Corneal Striae	2 (0.5)	0 (0)	0.50
Conjunctivitis	18 (4.5)	18 (4.5)	> 0.99
External Adnexa Abnormalities	11 (2.7)	14 (3.5)	0.55
Other Anterior Segment Abnormalities	59 (15)	38 (9.5)	0.03*

Notes: ^†Between-treatment p-value comparing proportions based on Fisher’s exact test. *Difference deemed significant at p < 0.05.

Table 5 Symptom/Complaint Scores Over All Follow-Up Visits (Dispensed Eyes)

Symptom/Complaint	Mean Score ± Sdev
	n	Samfilcon A	n	Balafilcon A
Burning/Stinging Upon Insertion	400	95.8 ± 7.3	398	93.9 ± 10.0
Ease of Handling/Insertion	400	95.9 ± 7.7	398	94.7 ± 8.4
Vision Upon Insertion	400	96.3 ± 6.0	398	94.5 ± 8.7
Comfort Upon Insertion	400	95.2 ± 7.1	398	92.2 ± 10.3
Ease of Handling/Removal	400	96.1 ± 6.7	399	94.9 ± 8.1
Lens Cleanness Upon Removal	400	91.7 ± 10.2	399	88 ± 13.3
Overall Comfort	402	90.8 ± 10.0	400	86 ± 14.2
Comfort at End of Day	402	87.9 ± 12.4	400	83 ± 16.3
Lens Handling	400	95.7 ± 7.4	399	94.5 ± 8.4
Dryness	402	85.4 ± 13.9	400	80.1 ± 16.9
Itchiness	402	92.7 ± 9.5	400	91.3 ± 11.9
Redness	402	92.9 ± 10.3	400	93.5 ± 9.8
Vision	402	95.2 ± 7.2	400	92.4 ± 10.0
Vision in Low Light	402	94.6 ± 7.6	400	92.5 ± 10.3
Vision at End of Day	402	92.7 ± 9.8	400	90.2 ± 11.9
Overall Impression	402	91.3 ± 9.9	400	86.6 ± 14.0

Notes: For each symptom, the score for each subject was obtained as follows: (1) the average score across OD and OS was calculated for each visit; (2) the mean of these per-visit averages was then calculated across all follow-up visits at which the subject presented data on the symptom.

Table 6 Subject-Wise Symptom/Complaint Unfavorable Findings Over All Follow-Up Visits

Symptom/Complaint	Number/Total (Percent) of Subjects Reporting an Unfavorable Finding on Either Eye on at Least One Follow-up Visit		^†,*p-value
	Samfilcon A	Balafilcon A
Burning/Stinging Upon Insertion	17/400 (4.3)	28/398 (7.0)	0.09
Ease of Handling/Insertion	15/400 (3.8)	12/398 (3.0)	0.70
Vision Upon Insertion	9/400 (2.3)	12/398 (3.0)	0.52
Comfort Upon Insertion	17/400 (4.3)	27/398 (6.8)	0.13
Ease of Handling/Removal	11/400 (2.8)	16/399 (4.0)	0.34
Lens Cleanness Upon Removal	23/400 (5.8)	47/399 (12)	0.003*
Overall Comfort	42/402 (10)	74/400 (19)	0.001*
Comfort at End of Day	48/402 (12)	81/400 (20)	0.002*
Lens Handling	6/400 (1.5)	10/399 (2.5)	0.33
Dryness	55/402 (14)	108/400 (27)	<0.0001*
Itchiness	49/402 (12)	53/400 (13)	0.67
Redness	54/402 (13)	41/400 (10)	0.19
Vision	23/402 (5.7)	38/400 (9.5)	0.046*
Vision in Low Light	20/402 (5.0)	36/400 (9.0)	0.03*
Vision at End of Day	25/402 (6.2)	41/400 (10)	0.04*
Overall Impression	27/402 (6.7)	50/400 (12)	0.006*

Notes: Unfavorable findings are defined as those with a reported score < 50. The reported tally is based upon subjects that presented data for that symptom on at least one follow-up visit. ^†Between-treatment p-value comparing proportions based on Fisher’s exact test. *Difference deemed significant at p < 0.05.