A Comparison of Efficacy and Safety of Two Lipid-Based Lubricant Eye Drops for the Management of Evaporative Dry Eye Disease

Figures & data

Figure 1 Study design.

Abbreviations: EOS, end of study; QID, four times daily; RFO-Ad, Refresh Optive Advance/Optive Plus; SYSB, Systane Balance; TFBUT, tear film break-up time.

Table 1 Demographic Characteristics of Patients by Treatment Groups–Randomized Set

	SYSB (N=117)	RFO-Ad (N=114)
Mean age, years (±SD)	56.7 (14.7)	55.6 (16.4)
Age group, n (%)
<65 years	78 (66.7)	72 (63.2)
≥65 years	39 (33.3)	42 (36.8)
Sex
Female, n (%)	90 (76.9)	92 (80.7)
Race, n (%)
White	81(69.2)	76 (66.7)
Black or African American	6 (5.1)	7 (6.1)
Asian	25 (21.4)	27 (23.7)
Multiracial	1 (0.9)	1 (0.9)
Other	4 (3.4)	3 (2.6)

Note: The randomized set consisted of all patients who were randomized to one of the study treatment arms.

Abbreviations: RFO-Ad, Refresh Optive Advance/Optive Plus; SD, standard deviation; SYSB, Systane Balance.

Figure 2 The change from baseline in TFBUT at Day 35 (test for non-inferiority, primary endpoint), by treatment group-PPS population.

Notes: Non-inferiority was deemed established if the lower limit of the 95% CI (equivalent to the 1-sided 97.5% CI) for the adjusted estimate of the difference (SYSB−RFO-Ad) was above −1.0 s.

Abbreviations: CI, confidence interval; LS, least squares; PPS, per-protocol set; RFO-Ad, Refresh Optive Advance/Optive Plus; SE, standard error; SYSB, Systane Balance; TFBUT, tear film break-up time.

Table 2 Summary of TFBUT, Global Ocular Discomfort VAS Score, and IDEEL Treatment-Satisfaction Scores (Effectiveness and Inconvenience) by Treatment Group at Each Study Visit- FAS Population

	SYSB N=117	RFO-Ad N=114
TFBUT, sec, Mean (SD)
Day 1	2.92 (1.14)	2.90 (1.15)
Day 15	3.65 (2.38)	3.41 (1.75) n=111
Day 35	3.91 (2.25)	3.76 (2.09) n=110
Change from baseline at Day 35	0.99 (1.93)	0.86 (1.62)
Global ocular discomfort VAS score (scale 0–100), Mean (SD)
Day 1	40.3 (27.56)	39.5 (25.96)
Day 15	33.2 (26.45)	33.2 (24.10) n=111
Day 35	30.4 (24.85)	30.6 (24.24) n=110
Change from baseline at Day 35	−9.9 (25.26)	−8.8 (26.11)
IDEEL Treatment Effectiveness score* (scale 0–100), Mean (SD)
Day 1	53.8 (29.56) n=105	49.8 (28.59) n=106
Day 15	61.7 (28.44) n=104	59.0 (24.63) n=103
Day 35	64.5 (25.76) n=105	61.8 (26.02) n=102
Change from baseline at Day 35	10.7 (32.00)	12.9 (31.64)
IDEEL Treatment Inconvenience score*, Mean (SD)
Day 1	81.2 (17.29) n=109	79.2 (15.77) n=108
Day 15	79.0 (17.73) n=108	75.3 (16.25) n=105
Day 35	79.1 (16.83) n=109	75.8 (17.50) n=104
Change from baseline at Day 35	−2.1 (21.33)	−2.8 (16.95)

Notes: Data values rounded off to the nearest two decimal points. FAS included all randomized subjects who had at least one post-baseline primary endpoint (ie, TFBUT) assessment. *Higher scores for Treatment effectiveness indicate greater satisfaction with treatment effectiveness; higher scores with Treatment-related Bother/Inconvenience indicated less treatment-related bother or inconvenience.

Abbreviations: FAS, full analysis set; IDEEL, impact of dry eye on everyday life; RFO-Ad, Refresh Optive Advance/Optive Plus; SD, standard deviation; SYSB, Systane Balance; VAS, visual analog scale; TFBUT, tear film break-up time.

Figure 3 Change from baseline in IDEEL treatment satisfaction scores (treatment effectiveness and treatment inconvenience scores) at Day 35, by treatment group-FAS population.

Note: P value<0.05 for a positive treatment difference (SYSB – RFO-Ad) would have favored SYSB.

Abbreviation: CI, confidence interval; FAS, full analysis set; IDEEL, impact of dry eye on everyday life; LS, least squares; RFO-Ad, Refresh Optive Advance/Optive Plus; SE, standard error; SYSB, Systane Balance.

Table 3 Proportion of Patients with Common Adverse Events (≥1.0% Incidence) by Preferred Term-Safety Analysis Set

Preferred Term	SYSB N=117 n (%)	RFO-Ad N=114 n (%)
Subjects with at least one AE(s)	14 (12.0)	16 (14.0)
Corneal dystrophy*	1 (0.9)	4 (3.5)
Conjunctival hyperaemia	1 (0.9)	3 (2.6)
Eye pain	0	3 (2.6)
Eye irritation	2 (1.7)	0
Posterior capsule opacification	0	2 (1.8)
Sinusitis	1 (0.9)	3 (2.6)
Vital dye staining cornea present	2 (1.7)	0
Oropharyngeal pain	0	2 (1.8)

Notes: *Corneal dystrophy was observed as corneal gutatta, a preexisting condition and was not considered to be related to study treatment. The safety analysis set included all subjects exposed to post-randomization study treatment.

Abbreviations: AE, adverse event; RFO-Ad, Refresh Optive Advance/Optive Plus; SYSB, Systane Balance.