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Effectiveness of Intense Pulsed Light for Improving Dry Eye Syndrome
NA trial testing IPL in Dry Eye Syndrome in 88 participants. Completed in 15 August 2019.
| Lead sponsor | Lumenis Be Ltd. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 88 |
| Start date | 10 January 2018 |
| Primary completion | 15 August 2019 |
| Estimated completion | 15 August 2019 |
| Sites | 2 locations across United States |
Lumenis Be Ltd. — full company profile →
Adults 22 to 85, any sex, with Dry Eye Syndrome. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Sham+MGX | 0.75 | ± 0.34 |
| IPL+MGX | 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.
| Group | Value | 95% CI |
|---|---|---|
| Sham+MGX | -25.9 | ± 3.6 |
| IPL+MGX | -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 co
| Group | Value | 95% CI |
|---|---|---|
| Sham+MGX | -25.9 | ± 3.6 |
| IPL+MGX | -32.96 | ± 3.97 |
Time frame: 10 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Sham+MGX | IPL+MGX |
|---|---|---|---|
| Sinus infection | General disorders | — | — |
| worsening of seasonal allergies | General disorders | — | — |
| Bronchitis | General disorders | — | — |
| Hyperlipidemia | General disorders | — | — |
| Allergic conjunctivitis | Eye disorders | — | — |
| Bacterial conjunctivitis | Eye disorders | — | — |
| Conjunctival telangiectasia | Eye disorders | — | — |
| Blepharitis | Skin and subcutaneous tissue disorders | — | — |
| Chalazion | Skin and subcutaneous tissue disorders | — | — |
| Pain | Skin and subcutaneous tissue disorders | — | — |
| Stye | Skin and subcutaneous tissue disorders | — | — |
Data from ClinicalTrials.gov NCT03396913 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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