. 2024 Jun 15;13(8):2083–2123. doi: 10.1007/s40123-024-00976-1

Table 4.

Summary of open-label studies evaluating LipiFlow to treat MGD

Author/design/country	Patients (eyes)/age, mean (SD)	Last FU	Study arms	MG function Mean (SD)	Patient-reported outcomes Mean (SD)	NIKBUT/TBUT Mean (SD)	Staining	Overall conclusion and safety
Liu 2023 [39] Prospective interventional China	N = 50 patients with MGD, LF: N = 25 patients (50 eyes), 36 (10) years; CL: N = 25 patients (50 eyes), 35 (6) years	3 months	Single 12-min LF Tx CL: warm eyelid with spontaneous steam eyelid masks for 20 min and massage for 15 min, 1x/day for 3 months	NR	MGE change from BL LF: − 0.46 (0.58)* CL: − 0.40 (0.49) MGSS change from BL LF: − 5.44 (3.23)* CL: − 3.28 (3.37)	NR	OSDI change from BL LF: − 17.4 (20.3)†* CL: -8.8 (13.5)	NR	NIKBUT change from BL LF:1.46 (2.18)* CL: 1.07 (2.33) TBUT change from BL LF:1.91 (0.87) CL: 1.49 (1.71)	NR	Corneal change from BL LF: − 0.52 (0.84)†* CL: − 0.18 (0.66)	LF improved MGD and was well tolerated AEs LF: N = 1 patient (slight irritation) CL: N = 10 patients (mild to severe pain/ discomfort). LF was significantly more comfortable than CL. No loss of VA or IOP > 21 mmHg
Novo-Diez 2022 [40] Prospective, single-center, open-label Spain	N = 21 patients with MGD exposed to adverse environmental humidity (42 eyes), 60 (9) years	12 months	Single 12-min LF Tx	MGYLS LF: 10.3 (1.5)	MGYLS LF: 12.2 (2.2)*	OSDI LF: 43.0 (23.9)	OSDI LF: 29.0 (22.2)*	TBUT LF: 4.2 (4.1)	TBUT LF: 4.3 (5.2)	Conjunct LF: 2 (2)	Conjunct LF: 0 (0)*	LF improves objective and subjective measures of MGD and the effects are sustained for ≥ 1 year AEs None. No significant changes in VA
Hu 2022 [19] Prospective, open-label, multicenter USA	N = 44 patients with MGD (88 eyes), 67 (8) years	Post-LF	Single 12-min LF Tx	–	–	–	–	–	–	Corneal LF: 3.1 (1.9) Conjunct LF: 3.4 (2.3)	Corneal LF: 3.9 (2.3)* Conjunct LF: 4.3 (2.9)* Note: the differences were considered statistically but not clinically significant	The LF Activator Clear enables efficient and confident positioning around the eyelids to ensure successful LF Tx when used as indicated AEs None. No safety-related concerns
Fallah 2021 [41] Prospective, open-label USA	N = 96 patients with MGD (192 eyes), age NR	3 months	Single 12-min LF Tx	NR	NR	OSDI LF: 35.7	OSDI LF: 30.1*	NR	NR	NR	NR	Significant improvement in subjective symptoms, but smaller than reported in previous studies AEs None
Chan 2021 [42] Prospective, observational Hong Kong	N = 16 patients with MGD (30 eyes), mean age NR	1 month	Single 12-min LF Tx	NR	NR	SPEED II LF: 12.9 (1.3)	SPEED II LF: 8.7 (0.7)*	NR	NR	NR	NR	LF Tx was effective in improving both objective and subjective measures of MGD. Safety NR
Li 2020 [43] Prospective, interventional China	N = 50 patients (50 eyes); N = 25 patients with OMGD (25 eyes), 37 (12) years; N = 25 patients with HMGD (25 eyes), 33 (10) years	3 months	Single 12-min LF Tx	MGSS LF/OMGD: xx¹ MGE LF/OMGD: xx¹	MGSS LF/OMGD: xx¹* MGE LF/OMGD: xx¹*	SPEED LF/OMDG: 12.0 (2.5) LF/HMGD: 12.1 (2.5) OSDI LF/OMDG: 22.9 (4.4) LF/HMGD: 24.1 (4.8)	SPEED LF/OMDG: 1.5 (1.3)† LF/HMGD: 5.2 (2.0) OSDI LF/OMDG: 1.7 (0.8)† LF/HMGD: 12.9 (4.1)	NIKBUT LF/OMDG: 3.2 (1.5) LF/HMGD: 3.2 (1.4)	NIKBUT LF/OMDG: 4.4 (1.4)*† LF/HMGD: 3.0 (1.1)	NR	NR	LF Tx was effective for OMGD and HMGD. It is more effective for OMGD. Safety NR
Godin 2018 [44] Prospective USA	N = 13 patients with Sjögren's disease (24 eyes), 62 years	1 year	Single 12-min LF Tx	NR	NR	OSDI LF: 40.4	OSDI LF: 47.6	TBUT LF: 3.8	TBUT LF: 7.5*	Corneal LF: 1.0 Conjunct LF: 1.5	Corneal LF: 0.48* Conjunct LF: 0.48*	LF Tx improved signs of DED and MGD in patients with symptomatic Sjögren's disease on maximum therapy. Safety NR
Zhao 2016 [50] Single-center, controlled, open-label Singapore	N = 46 patients with MG dropout; LF: N = 24 patients (24 eyes), 56 (13) years; CL: N = 22 patients (22 eyes), 56 (11) years	3 months	Single 12-min LF Tx plus daily manual lid massage and lid cleaning for 3 months CL: warm compress with towel 10 min/day BID plus daily manual lid massage and lid cleaning for 3 months	MGYLS LF: xx¹	MGYLS LF: xx¹*	SANDE LF: 45.6 (25.2) CL:52.4 (20.4)	SANDE % change from BL LF: − 30.5 (P < 0.05 vs. BL at 1 month but not 3 months) CL: − 15.9 (P < 0.05 vs. BL at 1 month but not 3 months)	TBUT LF: 2.4 (1.1) CL: 2.4 (1.3)	TBUT % change from BL LF: 89.2 (P < 0.05 vs. BL at 1 month but not 3 months) CL:63.0	NR	NR	In Asian patients, LF improved symptoms of MGD, and 1 session of LF was comparable to 3 months of BID lid warming, massage, and hygiene All LF Tx patients had transient eye redness and mild eyelid puffiness for a few min after Tx. No other AEs
Greiner 2016 [45] Prospective, observational, single-center USA	N = 20 patients with DED and MGD (40 eyes), 61 (11) years	3 years	Single 12-min LF Tx	MGSS LF: 4.5 MGYLS LF: 13.7% of glands studied	MGSS LF: 18.4* MGYLS LF: 53.7% of glands studied	SPEED LF: 13.4 OSDI LF: 26.0	SPEED LF: 9.5 (1.6)* OSDI LF: 22.5 (5.4) (P < 0.05 vs. BL at 1, 9 months, and 1 year but not 3 years)	TBUT LF: 4.1 (0.4)	TBUT LF: 4.5 (0.6) (P < 0.05 vs. BL at 1 month and 9 months but not 3 years)	Corneal LF: 0.4 (0.3) Conjunct LF:0.01 (0.03)	Corneal LF: 0.9 (0.6) Conjunct LF:0.8 (0.5)	The study reinforces the potential long-term (3 years) benefits of a single LF Tx. Safety NR
Blackie 2016 [11] Prospective, multicenter, open-label USA	N = 200 patients with MGD and evaporative dry eye (400 eyes); 56 (15) years; LF: 101 patients (202 eyes); CL: N = 99 patients (198 eyes); CO: N = 93 patients (186 eyes) in CL who were CO to LF	12 months (9 months for CO group)	Single 12-min LF Tx CL: warm compress with EyeGiene InstaWarmth and lid hygiene with OCuSOFT Lid Scrub Original 10 min/day BID for 3 months	MGSS LF: 6.2 (3.7) CL: 6.3 (3.7)	MGSS LF: 17.3 (9.1)* CL: 11.0 (at 3 months) CO: 18.4 (11.1)*	OSDI LF: 45.6 (21.2) CL: 51.8 (23.1)	OSDI LF: 21.6 (21.3)* CL: 31.3 (at 3 months) CO: 24.0 (23.2)*	NR	NR	NR	NR	LF Tx has sustained improvement in MG function and symptoms over 12 months AEs LF: N = 10 (N = 3 eye/eyelid discomfort/pain most common, others NR); CL: N = 8 (N = 3 eyelid skin dermatitis most common, others NR). All AEs transient, nonserious, and resolved with no Tx
Satjawatcharaphong 2015 [51] Open-label USA	N = 32 patients with DED and MGD (64 eyes), 54 (15) years	Mean 52 days (range: 21–84 days)	Single 12-min LF Tx plus warm compress, massage, and eyelid hygiene were recommended BID until FU	MGSS LF: 17.3 (12.9)	MGSS LF: 29.0 (12.6)*	SPEED LF: 15.7 (5.5)	SPEED LF: 12.9 (5.7)*	NIKBUT LF: 6.1 (3.2)	NIKBUT LF: 7.6 (2.6)	Corneal LF: 1.8 (3.8) Conjunct LF: 1.4 (2.1)	Corneal LF: 2.8 (6.6) Conjunct LF: 2.8 (6.6)	Results identified factors that better select candidates for LF Tx (At BL: men, higher inferior conjunctival staining, greater number of unexpressible glands) AEs NR Bulbar redness after at-home therapy (N = NR)
Greiner 2013 [46] Prospective, single-center, observational, open-label USA	N = 18 patients with MGD and evaporative DED (36 eyes), 63 (12) years Note: This is a subgroup, long-term FU from Lane 2012 [14]	12 months	Single 12-min LF Tx	MGSS LF: 4.0 (3.4)	MGSS LF: 7.3 (4.6)*	SPEED 12.9 (3.8) OSDI LF: 22.2 (14.2)	SPEED 6.3 (5.5)* OSDI LF: 12.4 (14.6)*	TBUT LF: 4.9 (3.0)	TBUT LF: 6.0 (4.4)	NR	NR	LF Tx-induced improvement is sustained for up to 1 year. Safety NR
Korb 2013 [47] Case report USA	N = 1 patient (2 eyes) with NOMGD with significant MG dropout and truncation	7 months	Single 12-min LF Tx	MGYLS LF OD: 1 LF OS: 1	MGYLS LF OD: 4 LF OS: 4	SPEED LF OD: 24.0 LF OS: 28.0	SPEED LF OD: 6.0 LF OS: 6.0	TBUT LF OD: 4 LF OS: 4	TBUT LF OD: 7 LF OS: 9	NR	NR	LF Tx was effective in a patient with significant gland dropout and truncation, and glands were restored to functional health for ≥ 7 months AEs None, no discomfort
Greiner 2012 [48] Prospective, open-label USA	N = 21 patients with MGD and dry eye (42 eyes), 62 years	9 months	Single 12-min LF Tx	MGSS LF: 4.4 (4.0)	MGSS LF: 11.7 (5.9)*	SPEED LF: 12.9 (4.0) OSDI LF: 23.4 (14.4)	SPEED LF: 6.2 (4.0)* OSDI LF: 12.4 (15.3)*	TBUT LF: 9.6 (7.6)	TBUT LF: 7.1 (5.6)*	NR	NR	LF Tx improved signs and symptoms of DED and was maintained for 9 months. Safety NR
Friedland 2011 [49] Multicenter, open-label feasibility USA	N = 14 patients with moderate-to-severe dry eye and MGD, 54 (10) years; LF: N = 14 eyes; CL: N = 14 eyes	3 months	Single 12-min LF Tx CL: Single 12-min LF Tx plus heat and pressure with a handheld device (type NR) with MGX to assess whether all material was removed	MGSS LF: 3.4 (3.2) CL: 2.5 (2.3) MGYLS LF: 2.9 (2.8) CL: 2.1 (2.4)	MGSS LF: 9.9 (3.2)* CL: 9.2 (4.3)* MGYLS LF: 9.9 (3.1)* CL: 10.5 (4.9)*	SPEED LF: 16.2 (5.4) CL: 16.2 (5.4) OSDI LF: 37.0 (23.8) CL: 37.9 (21.4)	SPEED LF: 7.8 (4.8)* CL: 7.8 (4.8)* OSDI LF: 18.3 (14.0)* CL: 24.5 (26.5)*	TBUT LF: 5.2 (2.6) CL: 5.8 (3.4)	TBUT LF: 11.0 (6.3)* CL:11.8 (5.9)*	Corneal LF: 0.6 (0.8) CL:0.6 (0.7)	Corneal LF: 0.1 (0.3)* CL: 0.1 (0.3)*	LF Tx was highly effective at improving signs and symptoms of MGD and DED for 3 months AEs N = 3 (discomfort, chalazion unrelated to Tx, internal hordeola unrelated to Tx)
Korb 2010 [13] Case report USA	N = 1 patient with NOMGD (2 eyes)	3 months	Single 12-min LF Tx	MGYLS LF OD: 0 LF OS: 1	MGYLS LF OD: 6 LF OS: 6	SPEED LF OD: 20.0 LF OS: 19.0 OSDI LF OD: 70.8 LF OS: 66.7	SPEED LF OD: 3.0 LF OS: 4.0 OSDI LF OD: 18.8 LF OS: 14.6	TBUT LF OD: 5.2 LF OS: 4.5	TBUT LF OD: 10.7 LF OS: 13.8	NR	NR	LF Tx was effective at treating NOMGD for at least 3 months AEs None, no significant discomfort Note: this is the first published report of the use of LF

Author/design/country

Patients (eyes)/age, mean (SD)

Last FU

Study arms

MG function
Mean (SD)

Patient-reported outcomes
Mean (SD)

NIKBUT/TBUT
Mean (SD)

Staining

Overall conclusion and safety

Pre

Post

Pre

Post

Pre

Post

Pre

Post

Liu 2023 [39]

Prospective interventional

China

N = 50 patients with MGD,

LF: N = 25 patients (50 eyes), 36 (10) years;

CL: N = 25 patients (50 eyes), 35 (6) years

3 months

Single 12-min LF Tx

CL: warm eyelid with spontaneous steam eyelid masks for 20 min and massage for 15 min, 1x/day for 3 months

MGE change from BL

LF: − 0.46 (0.58)*

CL: − 0.40 (0.49)

MGSS

change from BL

LF: − 5.44 (3.23)*

CL: − 3.28 (3.37)

OSDI change from BL

LF: − 17.4 (20.3)†*

CL: -8.8 (13.5)

NIKBUT change from BL

LF:1.46 (2.18)*

CL: 1.07 (2.33)

TBUT change from BL

LF:1.91 (0.87)

CL: 1.49 (1.71)

Corneal change from BL

LF: − 0.52 (0.84)†*

CL: − 0.18 (0.66)

LF improved MGD and was well tolerated

AEs

LF: N = 1 patient (slight irritation)

CL: N = 10 patients (mild to severe pain/ discomfort). LF was significantly more comfortable than CL. No loss of VA or IOP > 21 mmHg

Novo-Diez 2022 [40]

Prospective, single-center, open-label

Spain

N = 21 patients with MGD exposed to adverse environmental humidity (42 eyes), 60 (9) years

12 months

Single 12-min LF Tx

MGYLS

LF: 10.3 (1.5)

MGYLS

LF: 12.2 (2.2)*

OSDI

LF: 43.0 (23.9)

OSDI

LF: 29.0 (22.2)*

TBUT

LF: 4.2 (4.1)

TBUT

LF: 4.3 (5.2)

Conjunct

LF: 2 (2)

Conjunct

LF: 0 (0)*

LF improves objective and subjective measures of MGD and the effects are sustained for ≥ 1 year

AEs

None. No significant changes in VA

Hu 2022 [19]

Prospective, open-label, multicenter

USA

N = 44 patients with MGD (88 eyes), 67 (8) years

Post-LF

Single 12-min LF Tx

–

Corneal

LF: 3.1 (1.9)

Conjunct

LF: 3.4 (2.3)

Corneal

LF: 3.9 (2.3)*

Conjunct

LF: 4.3 (2.9)*

Note: the differences were considered statistically but not clinically significant

The LF Activator Clear enables efficient and confident positioning around the eyelids to ensure successful LF Tx when used as indicated

AEs

None. No safety-related concerns

Fallah 2021 [41]

Prospective, open-label

USA

N = 96 patients with MGD (192 eyes), age NR

3 months

Single 12-min LF Tx

OSDI

LF: 35.7

OSDI

LF: 30.1*

Significant improvement in subjective symptoms, but smaller than

reported in previous studies

AEs

None

Chan 2021 [42]

Prospective, observational

Hong Kong

N = 16 patients with MGD (30 eyes), mean age NR

1 month

Single 12-min LF Tx

SPEED II

LF: 12.9 (1.3)

SPEED II

LF: 8.7 (0.7)*

LF Tx was effective in improving both objective and subjective measures of MGD.

Safety NR

Li 2020 [43]

Prospective, interventional

China

N = 50 patients (50 eyes);

N = 25 patients with OMGD (25 eyes), 37 (12) years; N = 25 patients with HMGD (25 eyes), 33 (10) years

3 months

Single 12-min LF Tx

MGSS

LF/OMGD: xx¹

MGE

LF/OMGD: xx¹

MGSS

LF/OMGD: xx¹*

MGE

LF/OMGD: xx¹*

SPEED

LF/OMDG: 12.0 (2.5)

LF/HMGD: 12.1 (2.5)

OSDI

LF/OMDG: 22.9 (4.4)

LF/HMGD: 24.1 (4.8)

SPEED

LF/OMDG: 1.5 (1.3)*†

LF/HMGD: 5.2 (2.0)*

OSDI

LF/OMDG: 1.7 (0.8)*†

LF/HMGD: 12.9 (4.1)*

NIKBUT

LF/OMDG: 3.2 (1.5)

LF/HMGD: 3.2 (1.4)

NIKBUT

LF/OMDG: 4.4 (1.4)*†

LF/HMGD: 3.0 (1.1)

LF Tx was effective for OMGD and HMGD. It is more effective for OMGD.

Safety NR

Godin 2018 [44]

Prospective

USA

N = 13 patients with Sjögren's disease (24 eyes), 62 years

1 year

Single 12-min LF Tx

OSDI

LF: 40.4

OSDI

LF: 47.6

TBUT

LF: 3.8

TBUT

LF: 7.5*

Corneal

LF: 1.0

Conjunct

LF: 1.5

Corneal

LF: 0.48*

Conjunct

LF: 0.48*

LF Tx improved signs of DED and MGD in

patients with symptomatic Sjögren's disease

on maximum therapy.

Safety NR

Zhao 2016 [50]

Single-center, controlled, open-label

Singapore

N = 46 patients with MG dropout; LF: N = 24 patients (24 eyes), 56 (13) years;

CL: N = 22 patients (22 eyes), 56 (11) years

3 months

Single 12-min LF Tx plus daily manual lid massage and lid cleaning for 3 months

CL: warm compress with towel 10 min/day BID plus daily manual lid massage and lid cleaning for 3 months

MGYLS

LF: xx¹

MGYLS

LF: xx¹*

SANDE

LF: 45.6 (25.2)

CL:52.4 (20.4)

SANDE % change from BL

LF: − 30.5 (P < 0.05 vs. BL at 1 month but not 3 months)

CL: − 15.9 (P < 0.05 vs. BL at 1 month but not 3 months)

TBUT

LF: 2.4 (1.1)

CL: 2.4 (1.3)

TBUT % change from BL

LF: 89.2 (P < 0.05 vs. BL at 1 month but not 3 months)

CL:63.0

In Asian patients, LF improved symptoms of MGD, and 1 session of LF was comparable to 3 months of BID lid warming, massage, and hygiene

All LF Tx patients had transient eye redness and mild eyelid puffiness for a few min after Tx. No other AEs

Greiner 2016 [45]

Prospective, observational, single-center

USA

N = 20 patients with DED and MGD (40 eyes), 61 (11) years

3 years

Single 12-min LF Tx

MGSS

LF: 4.5

MGYLS

LF: 13.7% of glands studied

MGSS

LF: 18.4*

MGYLS

LF: 53.7% of glands studied

SPEED

LF: 13.4

OSDI

LF: 26.0

SPEED

LF: 9.5 (1.6)*

OSDI

LF: 22.5 (5.4) (P < 0.05 vs. BL at 1, 9 months, and 1 year but not 3 years)

TBUT

LF: 4.1 (0.4)

TBUT

LF: 4.5 (0.6) (P < 0.05 vs. BL at 1 month and 9 months but not 3 years)

Corneal

LF: 0.4 (0.3)

Conjunct

LF:0.01 (0.03)

Corneal

LF: 0.9 (0.6)

Conjunct

LF:0.8 (0.5)

The study reinforces the potential long-term (3 years) benefits of a single LF Tx.

Safety NR

Blackie 2016 [11]

Prospective, multicenter, open-label

USA

N = 200 patients with MGD and evaporative dry eye (400 eyes); 56 (15) years;

LF: 101 patients (202 eyes);

CL: N = 99 patients (198 eyes);

CO: N = 93 patients (186 eyes) in CL who were CO to LF

12 months (9 months for CO group)

Single 12-min LF Tx

CL: warm compress with EyeGiene InstaWarmth

and lid hygiene with OCuSOFT Lid Scrub

Original 10 min/day BID for 3 months

MGSS

LF: 6.2 (3.7)

CL: 6.3 (3.7)

MGSS

LF: 17.3 (9.1)*

CL: 11.0 (at 3 months)

CO: 18.4 (11.1)*

OSDI

LF: 45.6 (21.2)

CL: 51.8 (23.1)

OSDI

LF: 21.6 (21.3)*

CL: 31.3 (at 3 months)

CO: 24.0 (23.2)*

LF Tx has sustained improvement in MG function and symptoms over 12 months

AEs

LF: N = 10 (N = 3 eye/eyelid discomfort/pain most common, others NR);

CL: N = 8 (N = 3 eyelid skin dermatitis most common, others NR). All AEs transient, nonserious, and resolved with no Tx

Satjawatcharaphong 2015 [51]

Open-label

USA

N = 32 patients with DED and MGD (64 eyes), 54 (15) years

Mean 52 days (range: 21–84 days)

Single 12-min LF Tx plus warm

compress, massage, and eyelid hygiene were recommended

BID until FU

MGSS

LF: 17.3 (12.9)

MGSS

LF: 29.0 (12.6)*

SPEED

LF: 15.7 (5.5)

SPEED

LF: 12.9 (5.7)*

NIKBUT

LF: 6.1 (3.2)

NIKBUT

LF: 7.6 (2.6)

Corneal

LF: 1.8 (3.8)

Conjunct

LF: 1.4 (2.1)

Corneal

LF: 2.8 (6.6)

Conjunct

LF: 2.8 (6.6)

Results identified factors that better select candidates for LF Tx (At BL: men, higher inferior conjunctival staining, greater number of unexpressible glands)

AEs

Bulbar redness after at-home therapy (N = NR)

Greiner 2013 [46]

Prospective, single-center, observational, open-label

USA

N = 18 patients with MGD and evaporative DED (36 eyes), 63 (12) years

Note: This is a subgroup, long-term FU from Lane 2012 [14]

12 months

Single 12-min LF Tx

MGSS

LF: 4.0 (3.4)

MGSS

LF: 7.3 (4.6)*

SPEED

12.9 (3.8)

OSDI

LF: 22.2 (14.2)

SPEED

6.3 (5.5)*

OSDI

LF: 12.4 (14.6)*

TBUT

LF: 4.9 (3.0)

TBUT

LF: 6.0 (4.4)

LF Tx-induced improvement is sustained for up to 1 year.

Safety NR

Korb 2013 [47]

Case report

USA

N = 1 patient (2 eyes) with NOMGD with significant MG dropout and truncation

7 months

Single 12-min LF Tx

MGYLS

LF OD: 1

LF OS: 1

MGYLS

LF OD: 4

LF OS: 4

SPEED

LF OD: 24.0

LF OS: 28.0

SPEED

LF OD: 6.0

LF OS: 6.0

TBUT

LF OD: 4

LF OS: 4

TBUT

LF OD: 7

LF OS: 9

LF Tx was effective in a patient with significant gland dropout and truncation, and glands were restored to functional health for ≥ 7 months

AEs

None, no discomfort

Greiner 2012 [48]

Prospective, open-label

USA

N = 21 patients with MGD and dry eye (42 eyes), 62 years

9 months

Single 12-min LF Tx

MGSS

LF: 4.4 (4.0)

MGSS

LF: 11.7 (5.9)*

SPEED

LF: 12.9 (4.0)

OSDI

LF: 23.4 (14.4)

SPEED

LF: 6.2 (4.0)*

OSDI

LF: 12.4 (15.3)*

TBUT

LF: 9.6 (7.6)

TBUT

LF: 7.1 (5.6)*

LF Tx improved signs and symptoms of DED and was maintained for 9 months.

Safety NR

Friedland 2011 [49]

Multicenter, open-label feasibility

USA

N = 14 patients with moderate-to-severe dry eye and MGD, 54 (10) years;

LF: N = 14 eyes;

CL: N = 14 eyes

3 months

Single 12-min LF Tx

CL: Single 12-min LF Tx plus heat and pressure with a handheld device (type NR) with MGX to assess whether all material was removed

MGSS

LF: 3.4 (3.2)

CL: 2.5 (2.3)

MGYLS

LF: 2.9 (2.8)

CL: 2.1 (2.4)

MGSS

LF: 9.9 (3.2)*

CL: 9.2 (4.3)*

MGYLS

LF: 9.9 (3.1)*

CL: 10.5 (4.9)*

SPEED

LF: 16.2 (5.4)

CL: 16.2 (5.4)

OSDI

LF: 37.0 (23.8)

CL: 37.9 (21.4)

SPEED

LF: 7.8 (4.8)*

CL: 7.8 (4.8)*

OSDI

LF: 18.3 (14.0)*

CL: 24.5 (26.5)*

TBUT

LF: 5.2 (2.6)

CL: 5.8 (3.4)

TBUT

LF: 11.0 (6.3)*

CL:11.8 (5.9)*

Corneal

LF: 0.6 (0.8)

CL:0.6 (0.7)

Corneal

LF: 0.1 (0.3)*

CL: 0.1 (0.3)*

LF Tx was highly effective at improving signs and symptoms of MGD and DED for 3 months

AEs

N = 3 (discomfort, chalazion unrelated to Tx, internal hordeola unrelated to Tx)

Korb 2010 [13]

Case report

USA

N = 1 patient with NOMGD (2 eyes)

3 months

Single 12-min LF Tx

MGYLS

LF OD: 0

LF OS: 1

MGYLS

LF OD: 6

LF OS: 6

SPEED

LF OD: 20.0

LF OS: 19.0

OSDI

LF OD: 70.8

LF OS: 66.7

SPEED

LF OD: 3.0

LF OS: 4.0

OSDI

LF OD: 18.8

LF OS: 14.6

TBUT

LF OD: 5.2

LF OS: 4.5

TBUT

LF OD: 10.7

LF OS: 13.8

LF Tx was effective at treating NOMGD for at least 3 months

AEs

None, no significant discomfort

Note: this is the first published report of the use of LF

Units of measure are as follows: MGSS = points, score 0–45; MGYLS = number of functional glands; NIKBUT = seconds; OSDI = points, score 0–100; SANDE = visual analog scale score, 0–100; SPEED = points, score 0–28; staining = scale score; TBUT = seconds

Notes: Treatment manufacturers are as follows: EyeGiene^® InstaWarmth™ patch (Eyedetec Medical Inc, Danville, CA); OCuSOFT^® Lid Scrub™ Original (OCuSOFT, Rosenberg, TX)

AEs adverse events, BID 2 times per day, BL baseline, conjunct conjunctival, CL control, CO crossover group, DED dry eye disease, FU follow-up, HMGD hyposecretory meibomian gland disease, IOP intraocular pressure, LF LipiFlow, MGD meibomian gland disease, MGE meibomian gland expressibility score, MGSS meibomian gland secretion score (secretion quality, max 45 points), MGX manual gland expression, MGYLS meibomian glands yielding liquid secretion (glands with secretion capacity), min minutes, NIKBUT noninvasive keratograph break-up time, NOMGD nonobvious obstructive meibomian gland disease, NR not reported, OD right eye, OS left eye, OMGD obstructive meibomian gland disease, OSDI ocular surface disease index, pre pretreatment, post post-treatment, SANDE Symptom Assessment in Dry Eye, SD standard deviation, SPEED standard patient evaluation of eye dryness, TBUT tear break-up time, Tx treatment, VA visual acuity

¹Data only presented in a figure. We did not extrapolate the data from the figure to avoid presenting estimated data

^*P < 0.05 vs. baseline

^†P < 0.05 vs. comparator