Trial Outcomes & Findings for Effectiveness of Intense Pulsed Light for Improving Dry Eye Syndrome (NCT NCT03396913)

Results Overview

Change of Tear breakup time (TBUT) in the study eye, from baseline to follow-up. TBUT is measured in seconds. Higher values mean better outcome.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

88 participants

Primary outcome timeframe

10 weeks

Results posted on

2020-12-09

Participant Flow

Participant milestones

Participant milestones
Measure	Sham+MGX Sham IPL followed by meibomian gland expression (control group)	IPL+MGX Patients treated with IPL followed by meibomian gland expression (study group)
Overall Study STARTED	43	45
Overall Study COMPLETED	43	39
Overall Study NOT COMPLETED	0	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Sham+MGX Sham IPL followed by meibomian gland expression (control group)	IPL+MGX Patients treated with IPL followed by meibomian gland expression (study group)
Overall Study Lost to Follow-up	0	6

Baseline Characteristics

Effectiveness of Intense Pulsed Light for Improving Dry Eye Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sham+MGX n=43 Participants Sham IPL followed by meibomian gland expression (control group)	IPL+MGX n=45 Participants Patients treated with IPL followed by meibomian gland expression (study group)	Total n=88 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	32 Participants n=7 Participants	61 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Age, Continuous	56.8 years STANDARD_DEVIATION 12.7 • n=5 Participants	54.2 years STANDARD_DEVIATION 14.3 • n=7 Participants	55.5 years STANDARD_DEVIATION 13.6 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	20 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	25 Participants n=7 Participants	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants	39 Participants n=7 Participants	77 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	43 participants n=5 Participants	45 participants n=7 Participants	88 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 weeks

Change of Tear breakup time (TBUT) in the study eye, from baseline to follow-up. TBUT is measured in seconds. Higher values mean better outcome.

Outcome measures

Outcome measures
Measure	Sham+MGX n=43 Participants Sham IPL followed by meibomian gland expression (control group)	IPL+MGX n=39 Participants Patients treated with IPL followed by meibomian gland expression (study group)
Change of Baseline Tear Breakup Time (TBUT)	0.75 seconds Standard Error 0.34	1.99 seconds Standard Error 0.36

SECONDARY outcome

Timeframe: 10 weeks

Change of self-assessed symptoms with the Ocular Surface Disease Index (OSDI) questionnaire, from baseline to follow-up. OSDI was collected per patient (one number per patient). The minimal number is 0 and the maximal number is 100. Higher scores mean worse outcome. A score of 0-12 is considered normal. A score of 13-22 is consistent with mild dry eye. A score of 23 to 32 is consistent with moderate dry eye. A score from 33 to 100 is consistent with severe dry eye.

Outcome measures

Outcome measures
Measure	Sham+MGX n=43 Participants Sham IPL followed by meibomian gland expression (control group)	IPL+MGX n=39 Participants Patients treated with IPL followed by meibomian gland expression (study group)
Change From Baseline Ocular Surface Disease Index (OSDI)	-25.9 score on a scale Standard Error 3.6	-29.89 score on a scale Standard Error 3.78

SECONDARY outcome

Timeframe: 10 weeks

Change of self-assessed symptoms on a visual analog scale (VAS) , from baseline to follow-up, in both eyes. Values were collected separately for each eye. Correlation between eyes was removed by statistical methods. Scores were 0 (minimum) to 100 (maximum). Higher scores = worse outcome. VAS scores are not validated for dry eye. Hence, it is not known how to correlate VAS values to severity levels of dry eye. However, one can make estimations from the literature of VAS in other conditions. For example, in patients with chronic musculoskeletal pain, in a VAS scale of 0 to 10 scores below 3.4 corresponded to mild pain, scores between 3.5 and 7.4 corresponded to moderate pain, and scores above 7.5 corresponded to severe pain. Using such results from other conditions, it is \*estimated\* that values between 0 and 34 correspond to mild symptoms, scores between 35 and 74 correspond to moderate symptoms, and scores above 75 correspond to severe symptoms.

Outcome measures

Outcome measures
Measure	Sham+MGX n=43 Participants Sham IPL followed by meibomian gland expression (control group)	IPL+MGX n=39 Participants Patients treated with IPL followed by meibomian gland expression (study group)
Change From Baseline Eye Dryness Score (EDS)	-25.9 score on a scale Standard Error 3.6	-32.96 score on a scale Standard Error 3.97

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 weeks

High resolution photos of the upper and lower eyelids in both eyes

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 weeks

The difference in the percentage of area loss of meibomian glands, as evaluated using meibography, between eyes in the study arm and eyes in the control arm

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 weeks

The difference in the proportion of eyes with normal TBUT (TBUT \> 10 sec) at follow-up, between study eyes in the study arm and study eyes in the control arm

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 weeks

The difference in the proportion of subjects with normal OSDI (OSDI \< 23) at FU, between study eyes in the study arm and study eyes in the control arm

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 weeks

The difference in the incidence of ocular adverse events, between subjects in the study arm and subjects in the control arm

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 weeks

The difference in the incidence of non ocular adverse events, between subjects in the study arm and subjects in the control arm

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 weeks

The difference in the incidence of unanticipated serious adverse events, between subjects in the study arm and subjects in the control arm

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 weeks

difference in the change of bio-microscopy examinations pre- and post- treatment, between subjects in the study arm and subjects in the control arm

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 weeks

The difference in the self-assessment of pain/discomfort during IPL administration, between subjects in the study arm and subjects in the control arm

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 weeks

The difference in the self-assessment of pain/discomfort during MGX, between subjects in the study arm and subjects in the control arm

Outcome measures

Outcome data not reported

Adverse Events

Sham+MGX

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

IPL+MGX

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sham+MGX n=43 participants at risk Sham IPL followed by meibomian gland expression (control group)	IPL+MGX n=45 participants at risk Patients treated with IPL followed by meibomian gland expression (study group)
General disorders Bronchitis	2.3% 1/43 • 10 weeks	0.00% 0/45 • 10 weeks
General disorders Hyperlipidemia	2.3% 1/43 • 10 weeks	— 0/0 • 10 weeks
General disorders Sinus infection	4.7% 2/43 • 10 weeks	0.00% 0/45 • 10 weeks
General disorders worsening of seasonal allergies	4.7% 2/43 • 10 weeks	0.00% 0/45 • 10 weeks
Eye disorders Allergic conjunctivitis	0.00% 0/43 • 10 weeks	2.2% 1/45 • 10 weeks
Eye disorders Bacterial conjunctivitis	0.00% 0/43 • 10 weeks	2.2% 1/45 • 10 weeks
Eye disorders Conjunctival telangiectasia	2.3% 1/43 • 10 weeks	0.00% 0/45 • 10 weeks
Skin and subcutaneous tissue disorders Blepharitis	0.00% 0/43 • 10 weeks	2.2% 1/45 • 10 weeks
Skin and subcutaneous tissue disorders Chalazion	2.3% 1/43 • 10 weeks	0.00% 0/45 • 10 weeks
Skin and subcutaneous tissue disorders Pain	0.00% 0/43 • 10 weeks	2.2% 1/45 • 10 weeks
Skin and subcutaneous tissue disorders Stye	2.3% 1/43 • 10 weeks	0.00% 0/45 • 10 weeks

Additional Information

Yair Manor, Clinical Director

Lumenis

Phone: +972-52-3763416

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place