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Effectiveness of Intense Pulsed Light for Improving Dry Eye Syndrome

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ClinicalTrials.gov Identifier: NCT03396913
Recruitment Status : Completed
First Posted : January 11, 2018
Results First Posted : December 9, 2020
Last Update Posted : December 9, 2020
Sponsor:
Information provided by (Responsible Party):
Lumenis Be Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Dry Eye Syndrome
Interventions Device: IPL
Device: Sham IPL
Procedure: MGX
Enrollment 88
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sham+MGX IPL+MGX
Hide Arm/Group Description Sham IPL followed by meibomian gland expression (control group) Patients treated with IPL followed by meibomian gland expression (study group)
Period Title: Overall Study
Started 43 45
Completed 43 39
Not Completed 0 6
Reason Not Completed
Lost to Follow-up             0             6
Arm/Group Title Sham+MGX IPL+MGX Total
Hide Arm/Group Description Sham IPL followed by meibomian gland expression (control group) Patients treated with IPL followed by meibomian gland expression (study group) Total of all reporting groups
Overall Number of Baseline Participants 43 45 88
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 45 participants 88 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
29
  67.4%
32
  71.1%
61
  69.3%
>=65 years
14
  32.6%
13
  28.9%
27
  30.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 45 participants 88 participants
56.8  (12.7) 54.2  (14.3) 55.5  (13.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 45 participants 88 participants
Female
33
  76.7%
20
  44.4%
53
  60.2%
Male
10
  23.3%
25
  55.6%
35
  39.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 45 participants 88 participants
Hispanic or Latino
5
  11.6%
6
  13.3%
11
  12.5%
Not Hispanic or Latino
38
  88.4%
39
  86.7%
77
  87.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 43 participants 45 participants 88 participants
43 45 88
1.Primary Outcome
Title Change of Baseline Tear Breakup Time (TBUT)
Hide Description 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.
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham+MGX IPL+MGX
Hide Arm/Group Description:
Sham IPL followed by meibomian gland expression (control group)
Patients treated with IPL followed by meibomian gland expression (study group)
Overall Number of Participants Analyzed 43 39
Mean (Standard Error)
Unit of Measure: seconds
0.75  (0.34) 1.99  (0.36)
2.Secondary Outcome
Title Change From Baseline Ocular Surface Disease Index (OSDI)
Hide Description 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.
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham+MGX IPL+MGX
Hide Arm/Group Description:
Sham IPL followed by meibomian gland expression (control group)
Patients treated with IPL followed by meibomian gland expression (study group)
Overall Number of Participants Analyzed 43 39
Mean (Standard Error)
Unit of Measure: score on a scale
-25.9  (3.6) -29.89  (3.78)
3.Secondary Outcome
Title Change From Baseline Eye Dryness Score (EDS)
Hide Description 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.
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham+MGX IPL+MGX
Hide Arm/Group Description:
Sham IPL followed by meibomian gland expression (control group)
Patients treated with IPL followed by meibomian gland expression (study group)
Overall Number of Participants Analyzed 43 39
Mean (Standard Error)
Unit of Measure: score on a scale
-25.9  (3.6) -32.96  (3.97)
4.Other Pre-specified Outcome
Title Qualitative Assessment of Eyelid Appearance
Hide Description High resolution photos of the upper and lower eyelids in both eyes
Time Frame 10 weeks
Outcome Measure Data Not Reported
5.Other Pre-specified Outcome
Title Meiboscore
Hide Description 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
Time Frame 10 weeks
Outcome Measure Data Not Reported
6.Other Pre-specified Outcome
Title Percentage of Eyes With Normal Tear Break-Up Time (TBUT)
Hide Description 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
Time Frame 10 weeks
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Percentage of Subjects With Normal Ocular Surface Disease Index (OSDI)
Hide Description 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
Time Frame 10 weeks
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Incidence of Ocular Adverse Events
Hide Description The difference in the incidence of ocular adverse events, between subjects in the study arm and subjects in the control arm
Time Frame 10 weeks
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title Incidence of Non-ocular Adverse Events
Hide Description The difference in the incidence of non ocular adverse events, between subjects in the study arm and subjects in the control arm
Time Frame 10 weeks
Outcome Measure Data Not Reported
10.Other Pre-specified Outcome
Title Incidence of Unanticipated Serious Adverse Events
Hide Description The difference in the incidence of unanticipated serious adverse events, between subjects in the study arm and subjects in the control arm
Time Frame 10 weeks
Outcome Measure Data Not Reported
11.Other Pre-specified Outcome
Title Immediate Biomicroscopy
Hide Description difference in the change of bio-microscopy examinations pre- and post- treatment, between subjects in the study arm and subjects in the control arm
Time Frame 10 weeks
Outcome Measure Data Not Reported
12.Other Pre-specified Outcome
Title Pain/Discomfort During Intense Pulsed Light (IPL)
Hide Description The difference in the self-assessment of pain/discomfort during IPL administration, between subjects in the study arm and subjects in the control arm
Time Frame 10 weeks
Outcome Measure Data Not Reported
13.Other Pre-specified Outcome
Title Pain/Discomfort During Meibomian Gland Expression (MGX)
Hide Description The difference in the self-assessment of pain/discomfort during MGX, between subjects in the study arm and subjects in the control arm
Time Frame 10 weeks
Outcome Measure Data Not Reported
Time Frame 10 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sham+MGX IPL+MGX
Hide Arm/Group Description Sham IPL followed by meibomian gland expression (control group) Patients treated with IPL followed by meibomian gland expression (study group)
All-Cause Mortality
Sham+MGX IPL+MGX
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/45 (0.00%) 
Hide Serious Adverse Events
Sham+MGX IPL+MGX
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/45 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sham+MGX IPL+MGX
Affected / at Risk (%) Affected / at Risk (%)
Total   9/43 (20.93%)   4/45 (8.89%) 
Eye disorders     
Allergic conjunctivitis *  0/43 (0.00%)  1/45 (2.22%) 
Bacterial conjunctivitis *  0/43 (0.00%)  1/45 (2.22%) 
Conjunctival telangiectasia *  1/43 (2.33%)  0/45 (0.00%) 
General disorders     
Bronchitis * 1  1/43 (2.33%)  0/45 (0.00%) 
Hyperlipidemia * 1  1/43 (2.33%)  0/0 
Sinus infection * 1  2/43 (4.65%)  0/45 (0.00%) 
worsening of seasonal allergies *  2/43 (4.65%)  0/45 (0.00%) 
Skin and subcutaneous tissue disorders     
Blepharitis *  0/43 (0.00%)  1/45 (2.22%) 
Chalazion *  1/43 (2.33%)  0/45 (0.00%) 
Pain *  0/43 (0.00%)  1/45 (2.22%) 
Stye *  1/43 (2.33%)  0/45 (0.00%) 
1
Term from vocabulary, PT
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Yair Manor, Clinical Director
Organization: Lumenis
Phone: +972-52-3763416
EMail: yair.manor@lumenis.com
Layout table for additonal information
Responsible Party: Lumenis Be Ltd.
ClinicalTrials.gov Identifier: NCT03396913    
Other Study ID Numbers: LUM-VBU-M22-IPL-17-01
First Submitted: December 28, 2017
First Posted: January 11, 2018
Results First Submitted: September 6, 2020
Results First Posted: December 9, 2020
Last Update Posted: December 9, 2020