A single vectored thermal pulsation treatment for meibomian gland dysfunction increases mean comfortable contact lens wearing time by approximately 4 hours per day

Figures & data

Figure 1 An abbreviated CONSORT flow diagram indicating the complete subject disposition throughout the trial.

Abbreviations: ITT, intent-to-treat; PP, per protocol.

Table 1 Demographics for treatment (VTP) and untreated control groups: ITT population

Group	Treatment (VTP) (n=29)	Untreated control (n=26)	All subjects (n=55)
Age (years), mean ± SD	40.0±13.1	43.5±15.9	41.7±14.5
Gender
% male	13.8	15.4	14.6
% female	86.2	84.6	85.4
Race
% Asian	20.7	23.1	21.8
% Black/African American	17.2	15.4	13.4
% White/Caucasian	58.6	61.5	60.0
% other race (multiracial)	3.4	0.0	1.8

Abbreviations: ITT, intent-to-treat; SD, standard deviation; VTP, vectored thermal pulsation.

Table 2 Summary of primary and secondary endpoints: ITT population

Group	Treatment (VTP)			Untreated control		VTP vs control	Crossover VTP
Visit	Baseline	1 month	3 months	Baseline	3 months	Change baseline to 3 months#	4 months
Number (n) of subjects	29	29	29	26	25		25
Meibomian gland score (0–45), mean (SD)	8.0 (3.5)	19.7 (9.2)	20.4 (9.1)	8.2 (4.2)	9.6 (5.7)	p<0.0001	22.4 (9.4)
SPEED score (0–28), mean (SD)	14.5 (4.8)	6.2 (4.2)	6.1 (4.6)	15.3 (4.5)	14.5 (5.3)	p<0.0001	7.4 (5.0)*

Notes:

# p-value based on two sample t-test; p<0.05 statistically significant.

* One crossover treatment subject did not complete all questions on SPEED questionnaire at 4 months (N=24 subjects in ITT population).

Abbreviations: ITT, intent-to-treat; SD, standard deviation; SPEED, Standard Patient Evaluation of Eye Dryness; VTP, vectored thermal pulsation.

Table 3 Summary of statistically significant additional exploratory analyses

Group	Treatment (VTP)			Untreated control		VTP vs control	Crossover VTP
Visit	Baseline	1 month	3 months	Baseline	3 months	Change baseline to 3 months	4 months
ITT population: number (n) of subjects	29	29	29	26	25		25
Topical OTC use (times/month), mean (SD)	56.3 (45.1)	39.8 (30.8)	26.0 (30.6)	44.1 (36.0)	42.2 (39.1)	p=0.02#	26.6 (25.5)
Total OSDI score (0–100), mean (SD)	39.6 (16.4)	15.7 (13.4)	13.4 (15.5)	40.8 (20.3)	37.5 (23.8)	p=0.0002#	13.8 (11.2)
Number of functional meibomian glands (0–15 glands), mean (SD)	1.9 (1.6)	6.9 (3.8)	7.1 (3.6)	2.1 (1.7)	2.5 (2.2)	p<0.0001#	7.9 (3.6)
Tear break-up time (0–20 seconds), mean (SD)	4.8 (2.7)	5.7 (3.5)	6.5 (4.0)	4.6 (2.0)	4.3 (1.7)	p=0.0005#	5.3 (2.4)
LWE severity score (0–3), mean (SD)	1.8 (1.2)	1.5 (1.1)	1.4 (1.0)	1.7 (1.2)	1.8 (1.1)	p=0.04‡	1.3 (1.0)
PP population: number (n) of subjects	25	25	25	24	24		24
Total conjunctival stain grade (0–18), mean (SD)	3.5 (3.0)	3.8 (3.2)	3.4 (3.3)	4.3 (3.6)	5.6 (4.5)	p=0.04‡	3.6 (3.7)
Temporal LIPCOF grade (0–3), mean (SD)	1.7 (1.3)	1.3 (1.3)	1.1 (1.2)	1.5 (1.1)	1.4 (1.0)	p=0.04‡	1.1 (1.0)

Notes:

# p-value based on two sample t-test.

‡ p-value based on Wilcoxon rank sum test; p<0.05, statistically significant. Bold font indicates statistical significance.

Abbreviations: ITT, intent-to-treat; LIPCOF, lid parallel conjunctival folds; LWE, lid wiper epitheliopathy; OSDI, Ocular Surface Disease Index Questionnaire; OTC, over-the-counter; PP, per protocol; SD, standard deviation; VTP, vectored thermal pulsation.

Figure 2 The mean change in comfortable contact lens wear time from baseline to 3 months post-single VTP treatment.

Abbreviations: CL, contact lens; SD, standard deviation; VTP, vectored thermal pulsation.

Table 4 Summary of contact lens wear analyses by protocol revision: ITT population

Group	Treatment (VTP)			Untreated control		VTP vs control	Crossover VTP
Visit	Baseline	1 month	3 months	Baseline	3 months	Change baseline to 3 months#	4 months
Protocol	Revision 1
Number (n) of subjects	7	7	7	8	7		7
Total CL wear time/day (hours), mean (SD)	10.9 (1.6)	12.6 (2.3)	12.3 (1.7)	8.8 (2.5)	8.7 (3.7)	p=0.1	9.9 (3.2)
Comfortable CL wear time/day (hours), mean (SD) % comfortable wear/total	3.1 (1.1)	8.3 (4.0)	7.4 (2.6)	2.9 (1.1)	2.6 (1.3)	p=0.005	7.0 (3.0)
CL wear time, mean (SD)	29.9 (11.5)	67.6 (30.5)	63.1 (26.4)	35.5 (16.3)	30.9 (11.5)	p=0.008	71.2 (19.5)
Protocol	Revision 2
Number (n) of subjects	22	22	22	18	18		18
Total CL wear time/day (hours), mean (SD)	12.3 (3.4)	12.2 (3.2)	12.3 (3.3)	10.8 (3.1)	10.7 (3.5)	p=0.8	10.9 (2.8)
Comfortable CL wear time/day (hours), mean (SD) % comfortable wear/total	6.2 (3.5)	9.8 (3.9)	9.7 (4.0)	5.0 (3.5)	4.7 (2.9)	p=0.0002	8.4 (2.9)
CL wear time, mean (SD)	49.9 (22.5)	79.6 (21.1)	78.0 (21.7)	48.0 (31.5)	46.6 (24.0)	p=0.0002	76.9 (16.5)

Notes:

# p-value based on two sample t-test; p<0.05 statistically significant. Bold font indicates statistical significance.

Abbreviations: ITT, intent-to-treat; CL, contact lens; SD, standard deviation; VTP, vectored thermal pulsation.

Figure 3 DMI images from four different study subjects.

Notes: The images indicate different degrees of gland atrophy and three different DMI illumination methods. (A) Upper left eyelid using reflective infra-red illumination. (B) Lower left eyelid using infra-red transillumination. (C) Lower left eyelid using infra-red transillumination. (D) Lower left eyelid using the merged reflective illumination and infra-red transillumination.
Abbreviation: DMI, Dynamic Meibomian Imaging.

Figure 4 The mean change in OTC drop use frequency from baseline to 3 months post-single VTP treatment.

Abbreviations: OTC, over-the-counter; SD, standard deviation; VTP, vectored thermal pulsation.

Figure 5 The mean change in OSDI total and component scores from baseline to 3 months post-single VTP treatment.

Abbreviations: OSDI, Ocular Surface Disease Index; SD, standard deviation; VTP, vectored thermal pulsation.

Figure S1 Blinking exercises.

Note: Perform 10 repetitions every hour for a minimum of 10 times per day every day.