Efficacy and safety of dual-polymer hydroxypropyl guar- and hyaluronic acid-containing lubricant eyedrops for the management of dry-eye disease: a randomized double-masked clinical study

Figures & data

Figure 1 Study design.

Abbreviations: HPG-HA, hydroxypropyl guar–hyaluronic acid; QID, quater in die (four times a day); SH, sodium hyaluronate.

Table 1 Demographic characteristics of patients overall and by treatment group (ITT set)

	HPG-HA (n=50)	SH (n=49)	Overall (n=99)
Mean age, years (SD)	61.7 (12.29)	56.7 (14.29)	59.2 (13.49)
Age-group, n (%)(years)
18–64	30 (60.0)	31 (63.3)	61 (61.6)
≥65	20 (40.0)	18 (36.7)	38 (38.4)
Sex
Female, n (%)	41 (82.0)	38 (77.6)	79 (79.8)
Race, n (%)
White	42 (84.0)	38 (77.6)	80 (80.8)
Black/African-American	3 (6.0)	5 (10.2)	8 (8.1)
Asian	3 (6.0)	0	3 (3.0)
Other	2 (4.0)	6 (12.2)	8 (8.1)

Abbreviations: HPG-HA, hydroxypropyl guar–hyaluronic acid; ITT, intent to treat; SH, sodium hyaluronate; SD, standard deviation.

Table 2 Descriptive statistics of TOSS, IDEEL treatment-satisfaction scores (effectiveness and inconvenience), and TFBUT at baseline and each study visit (ITT set)

	HPG-HA (n=50)	SH (n=49)
TOSS, mean (SD)
Baseline	5.3 (1.41)	5.0 (1.09)
Day 15	4.6 (1.64)	4.5 (1.94)
Day 42	4.1 (2.07)	4.1 (1.98)
Change from baselinea	−1.1 (1.79), n=48	−0.9 (1.43), n=49
IDEEL treatment-effectiveness
score, mean (SD)
Baseline	52.04 (29.60)	51.56 (28.64)
Day 15	62.00 (24.51)	56.76 (29.17)
Day 42	61.72 (25.35)	64.80 (25.63)
Change from baselinea	10.11 (28.15), n=47	12.76 (26.64), n=48
IDEEL treatment-inconvenience
score, mean (SD)
Baseline	83.42 (17.75)	81.90 (17.83)
Day 15	78.13 (17.23)	82.02 (14.64)
Day 42	73.05 (20.35)	84.11 (17.01)
Change from baselinea	−10.24 (16.3), n=47	2.53 (16.57), n=46
TFBUT, seconds, mean (SD)
Baseline	3.2 (2.01)	3.58 (2.22)
Day 15	3.22 (1.44)	3.71 (2.31)
Day 42	3.68 (2.36)	4.19 (3.43)
Change from baselinea	0.46 (1.72), n=48	0.61 (3.43), n=49

Notes:

a Change from baseline to day 42, calculated for each patient available at day 42 visit and then summarized. If a patient did not attend the visit or did not have the measurement taken (at baseline or day 42), then they were excluded from baseline calculation. IDEEL treatment-satisfaction scores range 0–100. TOSS is calculated from three staining areas of the ocular surface: corneal, nasal conjunctival, and temporal conjunctival. Each area is scored 0–5, with total patient scores of 0–15.

Abbreviations: HPG-HA, hydroxypropyl guar–hyaluronic acid; IDEEL, impact of dry eye on everyday life; ITT, intent to treat; SH, sodium hyaluronate; SD, standard deviation; TFBUT, tear-film breakup time; TOSS, total ocular surface staining.

Figure 2 Change from baseline at day 42 in TOSS by treatment group (ITT set).

Note: *Noninferiority of HPG-HA to SH lubricant eyedrops was demonstrated (UL of 95% CI for the treatment difference between the groups was <2).
Abbreviations: HPG-HA, hydroxypropyl guar–hyaluronic acid; ITT, intent to treat; LS, least square; SE, standard error; SH, sodium hyaluronate; TOSS, total ocular surface staining; UL, upper limit.

Figure 3 Change from baseline at day 42 in IDEEL treatment-satisfaction scores (effectiveness and inconvenience) by treatment group (ITT set).

Note: *A positive difference would have favored HPG-HA.
Abbreviations: HPG-HA, hydroxypropyl guar–hyaluronic acid; IDEEL, impact of dry eye on everyday life; ITT, intent to treat; LS, least square; SE, standard error; SH, sodium hyaluronate.

Figure 4 Change from baseline at day 42 in TFBUT by treatment group (ITT set).

Note: *A positive difference would have favored HPG-HA.
Abbreviations: HPG-HA, hydroxypropyl guar–hyaluronic acid; ITT, intent to treat; LS, least square; SE, standard error; SH, sodium hyaluronate; TFBUT, tear-film breakup time.

Table 3 Most frequently (incidence ≥1%) reported ocular treatment-emergent adverse events by system-organ class and preferred term in each treatment group (safety set)

	HPG-HA (n=50)	SH (n=49)
Eye disorders, n (%)	9 (18.0)	10 (20.4)
Abnormal sensation in eye	2 (4.0)	1 (2.0)
Dry eye	0	1 (2.0)
Eye irritation	5 (10.0)	3 (6.1)
Eye pain	0	1 (2.0)
Eyelid edema	0	1 (2.0)
Foreign-body sensation in eyes	0	2 (4.1)
Halo vision	1 (2.0)	0
Lacrimal disorder	0	1 (2.0)
Meibomian gland dysfunction	0	1 (2.0)
Ocular hyperemia	0	1 (2.0)
Ocular jaundice	0	1 (2.0)
Vision blurred	5 (10.0)	1 (2.0)
Visual acuity reduced	1 (2.0)	2 (4.1)
Nervous system disorders, n (%)	1 (2.0)	0
Burning sensation	1 (2.0)	0
Surgical and medical procedures, n (%)	0	1 (2.0)
Eyelid operation	0	1 (2.0)

Note: Adverse events coded using MedDRA version 18.0.

Abbreviations: HPG-HA, hydroxypropyl guar–hyaluronic acid; SH, sodium hyaluronate.