An interventional study of Intense Pulsed Light (IPL) therapy and Sham therapy in Dry Eye and Meibomian Gland Dysfunction, sponsored by Lumenis Be Ltd.. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-21.
Sponsored by Lumenis Be Ltd. · Not applicable, Interventional, and Treatment
Among 14 studies in Dry Eye Syndromes with a site in Israel — none open to participants now, none under way, none of them phase 3. Dry Eye Syndromes · Israel.
Among the 14 studies in Dry Eye Syndromes with a site in Israel, this one is the 10th largest by enrollment of the 13 interventional ones that give a count, is the only one that started in 2018, is one of 9 with no phase, and was the 8th registered.
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
Browse Dry Eye Syndromes studies →None of the 14 studies in Dry Eye Syndromes with a site in Israel is open now.
Of the 116 Dry Eye Syndromes studies recruiting now, 73 (63%) set no upper age limit and 24 (21%) stop at 75 or younger; 7 take children under 18; 29 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
14 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 2 · Phase 3 2
First in 2007; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 24 is below the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Median enrollment 30 across the 13 interventional studies, 54 across the 1 observational. Of the 10 that completed or were terminated, 3 (30%) have results posted.
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11 of 14 have an industry lead sponsor. The 10 most frequent:
Lumenis Be Ltd. is the lead sponsor of 32 studies on the registry; 5 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Lumenis Be Ltd. has 6 studies filed under Dry Eye Syndromes — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 14 studies in Dry Eye Syndromes with a site in Israel, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The aim of the current study is to examine the contribution of intense pulsed light (IPL) for relieving signs and symptoms of dry eye due to meibomian gland dysfunction. The effect of IPL will be examined in a study designed as a randomized controlled trial. In the study arm, subjects will undergo 4 treatment sessions, consisting of IPL pulses immediately followed by expression of the meibomian glands. In the control arm, subjects will undergo the same treatments, except that the IPL pulses will be disabled. For each subject, the duration of the study will be 10 weeks, as explained in the detailed description,
Outcome measures (tear break-up time, tear film osmolarity, meibomian gland assessment, number of meibomian glands yielding liquid secretion in lower eyelid , meibography, self-assessed symptoms and close up photos of the lid margins) will be measured at baseline. All subjects will receive 4 treatments at 2 weeks intervals. In each treatment session, a subject allocated to the study group will be treated with IPL administered in the malar region, from tragus to tragus including the nose, 2-3 mm below the lower eyelids. Immediately following the IPL administration, the meibomian glands will be manually expressed from both eyelids. Subjects in the control arm will receive exactly the same treatment, except that the IPL administration will be sham. A single follow-up will occur at 10 weeks after the baseline (or 4 weeks after the 4th treatment session). At the follow-up, the changes in the outcome measures will be evaluated, and compared between the two arms.
For each subject, the duration of the study will be 10 weeks: 1st treatment at baseline; 2nd treatment at 2 weeks after baseline; 3rd treatment at 4 weeks after baseline; 4th treatment at 6 weeks after baseline; and a single follow-up at 10 weeks after baseline).
Statistically significant differences between the two arms will support the study hypothesis that IPL treatment itself provides relief to both signs and symptoms of dry eye disease.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects with receive 10-15 intense pulsed light (IPL) pulses on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and up to 3 mm from the lid margin of the lower eyelid. Following the administration of IPL pulses, subjects will undergo meibomian gland expression.
Device: Intense Pulsed Light (IPL) therapy
Participants will undergo a sham treatment that will mimic the intense pulsed light (IPL) therapy. The tip of the IPL lightguide will be placed in 10-15 locations on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and up to 3 mm from the lid margin of the lower eyelid, but IPL pulses will not be actually delivered. Following this sham procedure, subjects will undergo meibomian gland expression.
Device: Sham therapy
Intense pulsed light therapy is a non-invasive and non-laser light treatment that is FDA-approved for various conditions in dermatology. Subjects will receive a total of 4 treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications on 10-15 IPL pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression. Meibomian gland expression will be implemented by squeezing the meibomian glands with the aid of two Q-tips positioned on either side of the meibomian glands, or with a meibomian gland expressor forceps.
Subjects will receive a total of 4 treatments over the course of the study, at intervals of 2 weeks. Each treatment will include a sham application of IPL on 10-15 locations in the malar region and close to the lower eyelids, followed by meibomian gland expression. Meibomian gland expression will be implemented by squeezing the meibomian glands with the aid of two Q-tips positioned on either side of the meibomian glands, or with a meibomian gland expressor forceps.
Change of baseline TBUT
Change of Tear break up time in the study eye, from baseline to follow-up
Time frame: 10 weeks
Change from baseline MGA
Change of Meibomian gland secretion score, from baseline to follow-up, in both eyes
Time frame: 10 weeks
Change from baseline OSDI
Change of self-assessed symptoms with the OSDI questionnaire, from baseline to follow-up, in both eyes
Time frame: 10 weeks
Change from baseline MGYLS
Change of the number of meibomian glands yielding liquid secretion, from baseline to the follow-up
Time frame: 10 weeks
Change from baseline TFO
Change of the tear film osmolarity, from baseline to the follow-up
Time frame: 10 weeks
Change from baseline Meiboscore
Change of the Meiboscore evaluated with meibography, from baseline to the follow-up
Time frame: 10 weeks
Percentage of study eyes with normal TBUT
Percentage of study eyes with TBUT \> 10 seconds at the follow-up
Time frame: 10 weeks
Percentage of subjects with normal OSDI
Percentage of subjects with OSDI \< 23 at the follow-up
Time frame: 10 weeks
Percentage of subjects with normal MGA
Percentage of eyes with MGA \> 12 at the follow-up
Time frame: 10 weeks
Qualitative assessment of eyelid appearance
High resolution photos of the upper and lower eyelids in both eyes
Time frame: 10 weeks
Plan to share: Undecided — At this point it is not yet decided if and how to share IPD with other researchers
No publications or documents are linked to this record.
Ran from May 2018 to primary completion in Apr 2019, 11 months.
Of 113 industry-sponsored interventional studies with no phase under Dry Eye Syndromes, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 13. This study's 11 months is above that.
Counting every sponsor, half of 312 studies reached it within 10 months; a quarter within 4 and three quarters within 18.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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