An interventional study of IPL and Sham IPL in Dry Eye Syndrome, sponsored by Lumenis Be Ltd.. Completed at 2 sites in United States. Open to participants aged 22 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-12-09.
Sponsored by Lumenis Be Ltd. · Not applicable, Interventional, and Treatment
Among 542 studies in Dry Eye Syndromes with a site in United States — 51 open to participants now, 61 under way, 3 of them phase 3. Dry Eye Syndromes · United States.
Among the 542 studies in Dry Eye Syndromes with a site in United States, this one is the 200th largest by enrollment of the 472 interventional ones that give a count, is one of 36 that started in 2018, is one of 135 with no phase, and was the 253rd registered.
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
Browse Dry Eye Syndromes studies →51 of the 542 studies in Dry Eye Syndromes with a site in United States are open now. Recruiting first, the newest first:
Scott & Christie and Associates, PC · Sites in United States
Bausch & Lomb Incorporated · Sites in United States
Alcon Research · Sites in United States
Cleveland Eye Clinic · Sites in United States
Eye Research Associates, LLC · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
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: 22 Years to 85 Years · 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.
542 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 36 · Phase 2 132 · Phase 3 95 · Phase 4 116
First in 1997; this study’s year is marked. 36 started in 2018.
This study's enrollment of 88 is above the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Median enrollment 60 across the 472 interventional studies, 80 across the 63 observational. Of the 439 that completed or were terminated, 232 (53%) have results posted.
This tab as a report to print or save as PDF → With an account.
329 of 542 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.
29 of the studies in Dry Eye Syndromes with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07548632Phase 3OculisA Clinical Study Evaluating Licaminlimab for Dry Eye Disease | 2026-12 |
| NCT07768735Alcon ResearchUNITY DX Cornea Study | 2026-11 |
| NCT07281950Center for Sight Las VegasInvestigator Initiated Trial Using Dry Eye Surveys to Evaluate and Better Understand FDA Approved Acoltremon Treatment for Dry Eye Disease in Real World Treatment Settings (DESERT) | 2026-11-30 |
| NCT07566975Neuro-Ophthalmology of TexasReal-World Assessment of VEVYE® for Short-Term Symptom and Sign Improvement of Dry Eye Disease in a Neuro-Ophthalmology Clinic: A 6-Month Prospective Observational Study | 2026-11-30 |
| NCT07928986Cleveland Eye ClinicA Multi Center Evaluation of TearCare on Surgical Measurements Before Cataract Surgery | 2026-12 |
Among the 542 studies in Dry Eye Syndromes with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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 meibomian gland expression (MGX). 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,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 intense pulsed light (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 subject will undergo meibomian gland expression (MGX) in both eyelids of both eyes. 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 in the experimental arm with receive IPL followed by MGX: IPL pulses will be administered on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and below the lower eyelids. Following IPL therapy, subjects will undergo MGX of both eyelids in both eyes.
Device: IPL · Procedure: MGX
Subjects in the sham comparator arm with receive Sham IPL followed by MGX: Sham IPL pulses will be administered on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and below the lower eyelids. Following Sham IPL therapy, subjects will undergo MGX of both eyelids in both eyes.
Device: Sham IPL · Procedure: MGX
Intense pulsed light (IPL) 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 IPL treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications of 10-15 IPL pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression.
Sham intense pulsed light (IPL) will be implemented with an IPL device in which all light is blocked by a filter. Subjects will receive a total of 4 sham treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications of10-15 sham pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression.
Meibomian gland expression (MGX) 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 Tear Breakup Time (TBUT)
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
Change From Baseline Ocular Surface Disease Index (OSDI)
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
Change From Baseline Eye Dryness Score (EDS)
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
Qualitative Assessment of Eyelid Appearance
High resolution photos of the upper and lower eyelids in both eyes
Time frame: 10 weeks
Meiboscore
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
Percentage of Eyes With Normal Tear Break-Up Time (TBUT)
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
Percentage of Subjects With Normal Ocular Surface Disease Index (OSDI)
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
Incidence of Ocular Adverse Events
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
Incidence of Non-ocular Adverse Events
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
Incidence of Unanticipated Serious Adverse Events
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
Immediate Biomicroscopy
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
Pain/Discomfort During Intense Pulsed Light (IPL)
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
Pain/Discomfort During Meibomian Gland Expression (MGX)
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
| Milestone | Sham+MGX | IPL+MGX |
|---|---|---|
| Started | 43 | 45 |
| Completed | 43 | 39 |
| Not completed | 0 | 6 |
| Withdrew: Lost to follow-up | 0 | 6 |
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.
| seconds | Sham+MGX | IPL+MGX |
|---|---|---|
| Change of Baseline Tear Breakup Time (TBUT) | 0.75 ± 0.34 | 1.99 ± 0.36 |
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.
| score on a scale | Sham+MGX | IPL+MGX |
|---|---|---|
| Change From Baseline Ocular Surface Disease Index (OSDI) | -25.9 ± 3.6 | -29.89 ± 3.78 |
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.
| score on a scale | Sham+MGX | IPL+MGX |
|---|---|---|
| Change From Baseline Eye Dryness Score (EDS) | -25.9 ± 3.6 | -32.96 ± 3.97 |
High resolution photos of the upper and lower eyelids in both eyes
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
The difference in the incidence of ocular adverse events, between subjects in the study arm and subjects in the control arm
Results for this outcome have not been posted.
The difference in the incidence of non ocular adverse events, between subjects in the study arm and subjects in the control arm
Results for this outcome have not been posted.
The difference in the incidence of unanticipated serious adverse events, between subjects in the study arm and subjects in the control arm
Results for this outcome have not been posted.
difference in the change of bio-microscopy examinations pre- and post- treatment, between subjects in the study arm and subjects in the control arm
Results for this outcome have not been posted.
The difference in the self-assessment of pain/discomfort during IPL administration, between subjects in the study arm and subjects in the control arm
Results for this outcome have not been posted.
The difference in the self-assessment of pain/discomfort during MGX, between subjects in the study arm and subjects in the control arm
Results for this outcome have not been posted.
Collected over 10 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sham+MGX | 0/43 (0%) | 0/43 (0%) | 9/43 (20.9%) |
| IPL+MGX | 0/45 (0%) | 0/45 (0%) | 4/45 (8.9%) |
| Event | Sham+MGX | IPL+MGX |
|---|---|---|
| Sinus infectionGeneral disorders | 2/43 | 0/45 |
| worsening of seasonal allergiesGeneral disorders | 2/43 | 0/45 |
| BronchitisGeneral disorders | 1/43 | 0/45 |
| HyperlipidemiaGeneral disorders | 1/43 | — |
| Conjunctival telangiectasiaEye disorders | 1/43 | 0/45 |
| ChalazionSkin and subcutaneous tissue disorders | 1/43 | 0/45 |
| StyeSkin and subcutaneous tissue disorders | 1/43 | 0/45 |
| Allergic conjunctivitisEye disorders | 0/43 | 1/45 |
| Bacterial conjunctivitisEye disorders | 0/43 | 1/45 |
| BlepharitisSkin and subcutaneous tissue disorders | 0/43 | 1/45 |
| Age, Categorical(Participants) | Sham+MGX | IPL+MGX | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 29 | 32 | 61 |
| >=65 years | 14 | 13 | 27 |
| Age, Continuous(years) | Sham+MGX | IPL+MGX | Total |
|---|---|---|---|
| Mean | 56.8 ± 12.7 | 54.2 ± 14.3 | 55.5 ± 13.6 |
| Sex: Female, Male(Participants) | Sham+MGX | IPL+MGX | Total |
|---|---|---|---|
| Female | 33 | 20 | 53 |
| Male | 10 | 25 | 35 |
| Ethnicity (NIH/OMB)(Participants) | Sham+MGX | IPL+MGX | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 6 | 11 |
| Not Hispanic or Latino | 38 | 39 | 77 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Sham+MGX | IPL+MGX | Total |
|---|---|---|---|
| United States | 43 | 45 | 88 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2018 to primary completion in Aug 2019, 19 months.
Results were first posted in Dec 2020, 1 year 3 months after primary completion.
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 19 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 Sep 2020. You cannot join it, but the record below documents what was studied.
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