Dry Eye SyndromeNCT03569202

Piiloset Trehalose Emulsion Eye Drop Study in Moderate or Severe Dry Eye

A study testing Piiloset Trehalose Emulsion Eye Drops in people with Dry Eye Syndrome, run by Kuopio University Hospital at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study evaluates the safety, ocular tolerability and efficacy of emulsion eye drops with sacha inchi seed oil, trehalose and hyaluronic acid in the treatment of moderate or severe dry eye in adult patients. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Dry Eye Syndrome
What is being tested?: Piiloset Trehalose Emulsion Eye Drops
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteFinland
Study dates: 21 May 2018to 8 Nov 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Ability and willingness to give informed written consent prior to any screening procedure after explanation of the nature and possible consequences of the study.
Age between 18 and 80 years.
At least two the following conditions (A and B):
Symptomatic dry eye with OSDI score ≥20. AND B1. Tear film break-up time (TBUT) <10 seconds. OR B2. Positive ocular (corneal and conjunctival) staining pattern
Body weight at least 45 kg.
Under stable topical and/or systemic therapy for at least 4 weeks before the study procedures and apparent ability and willingness to abstain from other therapies until completion of the study period.

Show all 9Show fewer

Ability and willingness to self-administer eye drops.
Ability and willingness to understand and fill in the OSDI questionnaire.
Ability and willingness to comply with the study protocol and other study-related procedures.

Who cannot join

History of ocular surgery, trauma, or refractive laser vision correction procedure less than 3 months earlier.
Evidence of acute or chronic infection in the cornea or conjunctiva.
Diagnosis of Sjögren's syndrome.
Unwillingness or apparent disability to discontinue contact lens use during study period and at least one week before the first dosing day.
Current ocular allergy symptoms.
Known allergy to any constituent of the trehalose emulsion eye drops or control eye drops.
Currently pregnant, nursing or planning to become pregnant before completion of the study period.
Any other condition that may, in the Investigator's opinion, jeopardize the safety or availability of the subject or adherence to the study protocol or may interfere with the interpretation of the results and would thus make the subject inappropriate for entry in the study.

Trial locations and contacts

1 site in 1 country.

Finland1 site

Department of Ophthalmology, Kuopio University Hospital
Kuopio, FI-70200

Other trials in Finland

About this study

Official title: A Randomized, Active-controlled, Parallel, Double-blind Study on the Safety, Ocular Tolerability and Efficacy of Piiloset Trehalose Emulsion Eye Drop in Adult Patients With Moderate or Severe Dry Eye

Read the detailed description

According to the current view on dry eye disease, tear film instability, tear film hyperosmolarity, and ocular surface inflammation and damage are identified as etiological factors. The first-line medicinal management options include ocular lubricants such as eye drops and sprays. Emulsion eye drops are a relatively recent entity among topical therapies with an intention to account for deficiencies in the outermost lipid layer of the tear film.

Piiloset Trehalose Emulsion Eye Drops was developed to target and restore the three main layers (mucin, aqueous, and lipid) of the tear film and to counteract the key etiological factors leading to dry eye. Hyaluronic acid and the oil component are intended to restore tear film instability, the hypo-osmolar composition and trehalose as an osmoprotectant are intended to protect the ocular epithelium against hyperosmolarity, and ocular surface inflammation and cellular damage are prevented by the cytoprotective and/or anti-oxidative action of hyaluronic acid, trehalose, and sacha inchi oil components. Additional water binding in the tear film is provided by hyaluronic acid, trehalose, and glycerol. Lubricating the ocular surface by high-molecular-weight hyaluronic acid will extend the precorneal retention time. Adjustments made to certain physical and chemical parameters in the formulation are anticipated to improve tear film spreading and adhesion. The optically clear o/w emulsion formulation is free of preservatives, materials of animal origin, phosphates, or alcohol. The combined action of the individual components is expected to produce clinically relevant mitigation of the signs and symptoms of dry eye.

The study comprises three Parts with scheduled visits on Day 1 (all Parts) and on end-of-study date (Parts 2 and 3) to the study centre. Each study subject will participate in no more than one Part of the study.

Conditions: Dry Eye Syndrome
Being tested: Piiloset Trehalose Emulsion Eye Drops, Control Eye Drops
Keywords: Lubricant Eye Drops, Moderate or Severe Dry Eye, Hyaluronic Acid, Trehalose, Disaccharides, Polysaccharides, Fatty Acids, Omega-3, Tears, Osmolar Concentration, Anterior Eye Segment, Severity of Illness Index
Medical subject headings: Dry Eye Syndromes, Lymphoma, Follicular, Lacerations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Piiloset Trehalose Emulsion Eye DropsDevice
Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops 3 times daily
Control Eye DropsDevice
Topical application of preservative-free multidose Hyaluronic Acid Eye Drops 3 times daily

Study groups in NCT03569202
Study group	Role	What they receive
Emulsion Eye Drops	Experimental	Daily treatment with Piiloset Trehalose Emulsion Eye Drops Receives: Device: Piiloset Trehalose Emulsion Eye Drops
Control Eye Drops	Active comparator	Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device) Receives: Device: Control Eye Drops

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline OSDI
Ocular Surface Disease Index (OSDI) is a questionnaire consisting of 12 questions subdivided into 3 subscales for measuring the frequency of dry eye symptoms, vision-related quality of life and environmental triggers during the previous week. Answers to each question are on a scale of 0 (None of the time) to 4 (All of the time). Both total OSDI and its subscale scores are on a scale of 0 to 100, calculated as follows: score = (sum of scores for questions answered/number of questions answered) x 25. Higher scores represent greater disability.
Measured: From baseline to Day 30 (Part 3)
Change From Baseline Tear Osmolarity
Instrumental assay of tear fluid osmolarity (mOsm/L)
Measured: From baseline to Day 30 (Part 3)
Change From Baseline TBUT
Tear film break-up time (TBUT) (s)
Measured: From baseline to Day 30 (Part 3)

Secondary outcomes (5)

Change From Baseline Blink Rate
Measurement of spontaneous eyelid blinks per minute
Measured: From baseline to Day 30 (Part 3)
Change From Baseline Ocular Protection Index (OPI)
OPI is the ratio of TBUT/IBI (IBI, interblink interval calculated from blink rate). An OPI value >1 indicates that TBUT (s) exceeds IBI (s) and that the ocular surface is mostly tear-film protected, because tear film break-ups do not take place within spontaneous blink cycles.
Measured: From baseline to Day 30 (Part 3)
Change From Baseline Corneal Staining
Corneal staining score is assessed as the average number of punctate dots on an ordinal scale of 0, 1, 2, 3, 4, and 5 (Oxford scale) when compared to a pictorial standard. The number of dots increases on a log scale. Higher score represents more intense staining.
Measured: From baseline to Day 30 (Part 3)
Change From Baseline Conjunctival (Temporal) Staining
Conjunctival staining score is assessed as the average number of punctate dots on an ordinal scale of 0, 1, 2, 3, 4, and 5 (Oxford scale) when compared to a pictorial standard. The number of dots increases on a log scale. Higher score represents more intense staining.
Measured: From baseline to Day 30 (Part 3)
Change From Baseline Conjunctival (Nasal) Staining
Conjunctival staining score is assessed as the average number of punctate dots on an ordinal scale of 0, 1, 2, 3, 4, and 5 (Oxford scale) when compared to a pictorial standard. The number of dots increases on a log scale. Higher score represents more intense staining.
Measured: From baseline to Day 30 (Part 3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 May 20188 Nov 2018

First posted26 Jun 2018
Study start21 May 2018
Primary completion8 Nov 2018
Study completion8 Nov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Part 1. Piiloset Trehalose Emulsion Eye Drop is administered on the worst eye four times during office hours of one day at the study centre. Part 2. Piiloset Trehalose Emulsion Eye Drop is self-administered on a randomized eye and the control eye drops on the contralateral eye three times a day for 10 days in a double-blinded fashion. Part 3. Either Piiloset Trehalose Emulsion Eye Drop or the control eye drops are self-administered on both eyes three times a day for 30 days in a randomized and double-blinded fashion.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03569202
Sponsor's protocol ID: 5503762
Status last verified: Nov 2019
First submitted: 24 Apr 2018
Last updated: 13 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Laihia J, Jarvinen R, Wylegala E, Kaarniranta K. Disease aetiology-based design of multifunctional microemulsion eye drops for moderate or severe dry eye: a randomized, quadruple-masked and active-controlled clinical trial. Acta Ophthalmol. 2020 May;98(3):244-254. doi: 10.1111/aos.14252. Epub 2019 Oct 3.
PubMed 31579987

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Active-controlled, Parallel, Double-blind Study on the Safety, Ocular Tolerability and Efficacy of Piiloset Trehalose Emulsion Eye Drop in Adult Patients With Moderate or Severe Dry Eye
ClinicalTrials.gov ID: NCT03569202
Acronym / sponsor ID: 5503762
Conditions: Dry Eye Syndrome
Keywords: Lubricant Eye Drops, Moderate or Severe Dry Eye, Hyaluronic Acid, Trehalose, Disaccharides, Polysaccharides, Fatty Acids, Omega-3, Tears
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Kuopio University HospitalUniversity, hospital or other
Collaborators: Finnsusp Ltd., 4Pharma Ltd., Business Finland
Study start: 21 May 2018 (actual)
Primary completion: 8 Nov 2018 (actual)
Study completion: 8 Nov 2018 (actual)
First posted: 26 Jun 2018 (actual)
Results: Posted 13 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Part 1. Piiloset Trehalose Emulsion Eye Drop is administered on the worst eye four times during office hours of one day at the study centre. Part 2. Piiloset Trehalose Emulsion Eye Drop is self-administered on a randomized eye and the control eye drops on the contralateral eye three times a day for 10 days in a double-blinded fashion. Part 3. Either Piiloset Trehalose Emulsion Eye Drop or the control eye drops are self-administered on both eyes three times a day for 30 days in a randomized and double-blinded fashion.

Arm	Type	Receives
Emulsion Eye Drops	Experimental	Device: Piiloset Trehalose Emulsion Eye DropsDaily treatment with Piiloset Trehalose Emulsion Eye Drops
Control Eye Drops	Active comparator	Device: Control Eye DropsDaily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Ability and willingness to give informed written consent prior to any screening procedure after explanation of the nature and possible consequences of the study.
Age between 18 and 80 years.
At least two the following conditions (A and B):
Body weight at least 45 kg.
Under stable topical and/or systemic therapy for at least 4 weeks before the study procedures and apparent ability and willingness to abstain from other therapies until completion of the study period.

Key exclusion criteria (8 listed)

History of ocular surgery, trauma, or refractive laser vision correction procedure less than 3 months earlier.
Evidence of acute or chronic infection in the cornea or conjunctiva.
Diagnosis of Sjögren's syndrome.
Unwillingness or apparent disability to discontinue contact lens use during study period and at least one week before the first dosing day.
Current ocular allergy symptoms.

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
Piiloset Trehalose Emulsion Eye DropsTopical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops 3 times daily	Device	Emulsion Eye Drops
Control Eye DropsTopical application of preservative-free multidose Hyaluronic Acid Eye Drops 3 times daily	Device	Control Eye Drops

Primary outcome

Change From Baseline OSDI
Time frame: From baseline to Day 30 (Part 3)
Ocular Surface Disease Index (OSDI) is a questionnaire consisting of 12 questions subdivided into 3 subscales for measuring the frequency of dry eye symptoms, vision-related quality of life and environmental triggers during the previous week. Answers to each question are on a scale of 0 (None of the time) to 4 (All of the time). Both total OSDI and its subscale scores are on a scale of 0 to 100, calculated as follows: score = (sum of scores for questions answered/number of questions answered) x 25. Higher scores represent greater disability.
Change From Baseline Tear Osmolarity
Time frame: From baseline to Day 30 (Part 3)
Instrumental assay of tear fluid osmolarity (mOsm/L)
Change From Baseline TBUT
Time frame: From baseline to Day 30 (Part 3)
Tear film break-up time (TBUT) (s)

5 secondary outcomes

Change From Baseline Blink Rate
Time frame: From baseline to Day 30 (Part 3)
Change From Baseline Ocular Protection Index (OPI)
Time frame: From baseline to Day 30 (Part 3)
Change From Baseline Corneal Staining
Time frame: From baseline to Day 30 (Part 3)
Change From Baseline Conjunctival (Temporal) Staining
Time frame: From baseline to Day 30 (Part 3)
Change From Baseline Conjunctival (Nasal) Staining
Time frame: From baseline to Day 30 (Part 3)

Results and safety

Results posted to the registry on 13 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Emulsion Eye Drops	3	3
Control Eye Drops	0	0

Primary outcome: Change From Baseline OSDI

Time frame: From baseline to Day 30 (Part 3). Mean (Standard Deviation). Unit: units on a scale

Measure	Emulsion Eye Drops n = 26	Control Eye Drops n = 26
Value	-24.64 (16.186)	-26.53 (14.620)

Emulsion Eye Drops vs Control Eye Drops: Mean Difference (Final Values): 1.8837 (95% CI -6.7081 to 10.4756), p = 0.662, ANOVA
Emulsion Eye Drops: Mean Difference (Final Values): -24.6445 (95% CI -30.7199 to -18.5692), p <0.0001, ANOVA
Control Eye Drops: Mean Difference (Final Values): -26.5283 (95% CI -32.6036 to -20.4529), p <0.0001, ANOVA

Population analysed: Intent-to-treat (ITT) dataset

Primary outcome: Change From Baseline Tear Osmolarity

Time frame: From baseline to Day 30 (Part 3). Mean (Standard Deviation). Unit: mOsm/L

Measure	Emulsion Eye Drops n = 26	Control Eye Drops n = 26
Value	-4.75 (16.224)	-1.77 (21.531)

Emulsion Eye Drops vs Control Eye Drops: Mean Difference (Final Values): -2.9808 (95% CI -13.6005 to 7.6390), p = 0.575, ANOVA
Emulsion Eye Drops: Mean Difference (Final Values): -4.7500 (95% CI -12.2593 to 2.7593), p = 0.2098, ANOVA
Control Eye Drops: Mean Difference (Final Values): -1.7692 (95% CI -9.2785 to 5.7401), p = 0.6381, ANOVA

Population analysed: Intent-to-treat (ITT) dataset

Primary outcome: Change From Baseline TBUT

Time frame: From baseline to Day 30 (Part 3). Mean (Standard Deviation). Unit: s

Measure	Emulsion Eye Drops n = 26	Control Eye Drops n = 26
Value	1.71 (3.424)	0.87 (1.809)

Emulsion Eye Drops vs Control Eye Drops: Mean Difference (Final Values): 0.8462 (95% CI -0.6792 to 2.3715), p = 0.271, ANOVA
Emulsion Eye Drops: Mean Difference (Final Values): 1.7115 (95% CI 0.6330 to 2.7901), p = 0.0025, ANOVA
Control Eye Drops: Mean Difference (Final Values): 0.8654 (95% CI -0.2132 to 1.9440), p = 0.1134, ANOVA

Population analysed: Intent-to-treat (ITT) dataset

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Part 1: 1 day; Part 2: 10 days; Part 3: 30 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Emulsion Eye Drops	0 of 38 (0%)	1 of 38 (2.6%)	0 of 38
Control Eye Drops	0 of 35 (0%)	0 of 35 (0%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 31579987Laihia J, Jarvinen R, Wylegala E, Kaarniranta K. Disease aetiology-based design of multifunctional microemulsion eye drops for moderate or severe dry eye: a randomized, quadruple-masked and active-controlled clinical trial. Acta Ophthalmol. 2020 May;98(3):244-254. doi: 10.1111/aos.14252. Epub 2019 Oct 3.
Individual participant dataSharing planned: No

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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.

Kai Kaarniranta, Professor principal investigator

Kuopio University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Piiloset Trehalose Emulsion Eye Drops in people with Dry Eye Syndrome, run by Kuopio University Hospital at 1 site in Finland.

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 9 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 13 Dec 2019. 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 Finland. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline OSDI (time frame: From baseline to Day 30 (Part 3)). The study lists 3 primary outcomes in all. 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 NCT03569202, 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 13 Dec 2019.