Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Schepens Eye Research Institute | OTHER |
| The Norwegian Dry Eye Clinic | OTHER_GOV |
Not provided
Not provided
Not provided
An open label, randomized controlled study in a Norwegian population with meibomian gland dysfunction. Patients will be randomized to one of two groups: THERA°PEARL Eye Mask (Bausch & Lomb Inc., New York, USA) or Blephasteam® (Spectrum Thea Pharmaceuticals LTD, Macclesfield, UK). All patients will receive Hylo-comod (URSAPHARM Arzneimittel GmbH, Saarbrücken, Germany).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blephasteam | Experimental | Heat delivery device, to be used according to guidelines from manufacturer. |
|
| THERA°PEARL Eye Mask | Active Comparator | Heat delivery device, to be used according to guidelines from manufacturer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blephasteam | Device | Steam delivery goggles, once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Tear film break-up time | Fluorescein applied to tear film, time measured until tear film breaks up after blink. Range of scale from 1 second and higher, where higher values are considered preferable for the patients. Values under 10 seconds are indicative for dry eye disease. | Change from baseline at three and six months |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Surface Disease Index | Dry Eye Self reported Questionnaire, score ranging from 0-100, where lower values are considered preferable for the patients, indicating less symptoms. Values over 12 are indicative for dry eye disease. | Change from baseline at three and six months |
| McMonnies Questionnaire |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tor P Uthiem, MD, Phd. | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Norwegian Dry Eye Clinic | Oslo | 0369 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34789807 | Derived | Olafsson J, Lai X, Landsend ECS, Olafsson S, Parissi E, Utheim OA, Raeder S, Badian RA, Lagali N, Dartt DA, Utheim TP. TheraPearl Eye Mask and Blephasteam for the treatment of meibomian gland dysfunction: a randomized, comparative clinical trial. Sci Rep. 2021 Nov 17;11(1):22386. doi: 10.1038/s41598-021-01899-8. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 11, 2017 | Oct 13, 2017 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D005141 | Eyelid Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| THERA°PEARL Eye Mask |
| Device |
Heat delivery device, delivering heat to the eyelids, once daily |
|
| Hylo-comod | Drug | Tear substitute containing hyaluronic acid, four times daily |
|
|
Dry Eye Self reported Questionnaire. Index ranges from 0 to 45, where a higher score is regarded as more indicative of dry eye disease. A cut-point of greater than 14.5 is recommended for a dry eye diagnosis. |
| Change from baseline at three and six months |
| Ocular surface staining Ocular surface staining | Fluorescein applied to tear film, staining scored after the Oxford staining scheme, values ranging from 0-15, lower values are considered better for the patient. | Change from baseline at three and six months |
| Tear cytokine levels | Multiplex analysis of tear fluid | Change from baseline at three and six months |
| Schirmer's test | Measurement of 5 minutes of tear production, values ranging from 0 and higher, where lower values are considered worse for the patient. Values under 5 mm are indicative for dry eye disease. | Change from baseline at three and six months |
| Meibum Quality | Guidelines based on MGD-report of 2011, values ranging from 0-24, where lower values are considered better for the patient, indicating the quality of the meibum secretion. | Change from baseline at three and six months |
| Meibum Expressibility | Guidelines based on MGD-report of 2011, values ranging from 0-3, where lower values are considered better for the patient, indicating open meibomian glands. | Change from baseline at three and six months |
| Tear osmolarity | Osmolarity measured with TearLab, where values under 300 mOsml/L are considered normal. | Change from baseline at three and six months |