Dry Eye SyndromesPhase 4NCT03318874
Optimization of the Treatment of Dry Eye Disease Caused by Meibomian Gland Dysfunction
A Phase 4 study testing Blephasteam, THERA°PEARL Eye Mask and Hylo-comod in people with Dry Eye Syndromes and Meibomian Gland Dysfunction, run by Oslo University Hospital at 1 site in Norway.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes, Meibomian Gland Dysfunction
- What is being tested?
- Blephasteam, THERA°PEARL Eye Mask and Hylo-comod
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteNorway
- Study dates
- 19 Oct 2017to 17 Nov 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meibomian Gland Dysfunction
- Eligible for heat treatment
- Ocular Surface Disease Index (OSDI) >12
- Quality or expressibility score ≤20 years old: >1 or >20 years old: ≥1
- Non-invasive tear film break-up time (NITBUT) <10 s in at least one eye
- Schirmer-1 test >5 mm after 5 min
Who cannot join
- Glaucoma,
- Ocular allergy
- Autoimmune disease
- Contact lens-wear during study
- Current punctal plugging
- Pregnant/lactating
- Candidate for topical anti-inflammatory
- Cicatricial meibomian gland dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Effects of THERA°PEARL Eye Mask (Bausch & Lomb Inc., New York, USA) With the Use of Blephasteam® (Spectrum Thea Pharmaceuticals LTD, Macclesfield, UK).
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).
- Conditions
- Dry Eye Syndromes, Meibomian Gland Dysfunction
- Being tested
- Blephasteam, THERA°PEARL Eye Mask, Hylo-comod
- Keywords
- Dry Eye Disease, Meibomian Gland Dysfunction, Blephasteam, THERA°PEARL Eye Mask
- Medical subject headings
- Dry Eye Syndromes, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlephasteamDevice
Steam delivery goggles, once daily
THERA°PEARL Eye MaskDevice
Heat delivery device, delivering heat to the eyelids, once daily
Hylo-comodDrug
Also called Sodium hyaluronate
Tear substitute containing hyaluronic acid, four times daily
| Study group | Role | What they receive |
|---|---|---|
| Blephasteam | Experimental | Heat delivery device, to be used according to guidelines from manufacturer. Receives: Device: Blephasteam; Drug: Hylo-comod |
| THERA°PEARL Eye Mask | Active comparator | Heat delivery device, to be used according to guidelines from manufacturer. Receives: Device: THERA°PEARL Eye Mask; Drug: Hylo-comod |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline at three and six months
Secondary outcomes (8)
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.
Measured: Change from baseline at three and six months
McMonnies Questionnaire
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.
Measured: 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.
Measured: Change from baseline at three and six months
Tear cytokine levels
Multiplex analysis of tear fluid
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline at three and six months
Tear osmolarity
Osmolarity measured with TearLab, where values under 300 mOsml/L are considered normal.
Measured: Change from baseline at three and six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start19 Oct 2017
- Primary completion15 Apr 2020
- Study completion17 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Schepens Eye Research Institute, The Norwegian Dry Eye Clinic
- Responsible party
- Principal investigator, Jonatan Olafsson, Oslo University Hospital
- Investigators
- Tor P Uthiem, MD, Phd., Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318874
- Sponsor's protocol ID
- 2014/1983
- Status last verified
- Nov 2021
- First submitted
- 4 Oct 2017
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34789807
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effects of THERA°PEARL Eye Mask (Bausch & Lomb Inc., New York, USA) With the Use of Blephasteam® (Spectrum Thea Pharmaceuticals LTD, Macclesfield, UK).
- ClinicalTrials.gov ID
- NCT03318874
- Acronym / sponsor ID
- 2014/1983
- Conditions
- Dry Eye Syndromes, Meibomian Gland Dysfunction
- Keywords
- Dry Eye Disease, Meibomian Gland Dysfunction, Blephasteam, THERA°PEARL Eye Mask
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Schepens Eye Research Institute, The Norwegian Dry Eye Clinic
- Study start
- 19 Oct 2017 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 17 Nov 2021 (actual)
- First posted
- 24 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blephasteam | Experimental | Device: Blephasteam, Drug: Hylo-comodHeat delivery device, to be used according to guidelines from manufacturer. |
| THERA°PEARL Eye Mask | Active comparator | Device: THERA°PEARL Eye Mask, Drug: Hylo-comodHeat delivery device, to be used according to guidelines from manufacturer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Meibomian Gland Dysfunction
- Eligible for heat treatment
- Ocular Surface Disease Index (OSDI) >12
- Quality or expressibility score ≤20 years old: >1 or >20 years old: ≥1
- Non-invasive tear film break-up time (NITBUT) <10 s in at least one eye
Key exclusion criteria (8 listed)
- Glaucoma,
- Ocular allergy
- Autoimmune disease
- Contact lens-wear during study
- Current punctal plugging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BlephasteamSteam delivery goggles, once daily | Device | Blephasteam |
| THERA°PEARL Eye MaskHeat delivery device, delivering heat to the eyelids, once daily | Device | THERA°PEARL Eye Mask |
| Hylo-comodAlso: Sodium hyaluronateTear substitute containing hyaluronic acid, four times daily | Drug | Blephasteam, THERA°PEARL Eye Mask |
Primary outcome
Tear film break-up time
Time frame: Change from baseline at three and six months
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.
8 secondary outcomes
Ocular Surface Disease Index
Time frame: Change from baseline at three and six months
McMonnies Questionnaire
Time frame: Change from baseline at three and six months
Ocular surface staining Ocular surface staining
Time frame: Change from baseline at three and six months
Tear cytokine levels
Time frame: Change from baseline at three and six months
Schirmer's test
Time frame: Change from baseline at three and six months
Meibum Quality
Time frame: Change from baseline at three and six months
Meibum Expressibility
Time frame: Change from baseline at three and six months
Tear osmolarity
Time frame: Change from baseline at three and six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Derived from this study: PubMed 34789807Olafsson 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tor P Uthiem, MD, Phd. principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blephasteam, THERA°PEARL Eye Mask and Hylo-comod in people with Dry Eye Syndromes and Meibomian Gland Dysfunction, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tear film break-up time (time frame: Change from baseline at three and six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03318874, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.