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

Primary Purpose

Dry Eye Syndrome

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Piiloset Trehalose Emulsion Eye Drops
Control Eye Drops
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndrome focused on measuring 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

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Ability and willingness to give informed written consent prior to any screening procedure after explanation of the nature and possible consequences of the study.
  2. Age between 18 and 80 years.

  3. At least two the following conditions (A and B):

    A. 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

  4. Body weight at least 45 kg.
  5. 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.
  6. Ability and willingness to self-administer eye drops.
  7. Ability and willingness to understand and fill in the OSDI questionnaire.
  8. Ability and willingness to comply with the study protocol and other study-related procedures.

Exclusion Criteria:

  1. History of ocular surgery, trauma, or refractive laser vision correction procedure less than 3 months earlier.
  2. Evidence of acute or chronic infection in the cornea or conjunctiva.
  3. Diagnosis of Sjögren's syndrome.
  4. Unwillingness or apparent disability to discontinue contact lens use during study period and at least one week before the first dosing day.
  5. Current ocular allergy symptoms.
  6. Known allergy to any constituent of the trehalose emulsion eye drops or control eye drops.
  7. Currently pregnant, nursing or planning to become pregnant before completion of the study period.
  8. 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.

Sites / Locations

  • Department of Ophthalmology, Kuopio University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Emulsion Eye Drops

Control Eye Drops

Arm Description

Daily treatment with Piiloset Trehalose Emulsion Eye Drops

Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)

Outcomes

Primary Outcome Measures

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.
Change From Baseline Tear Osmolarity
Instrumental assay of tear fluid osmolarity (mOsm/L)
Change From Baseline TBUT
Tear film break-up time (TBUT) (s)

Secondary Outcome Measures

Change From Baseline Blink Rate
Measurement of spontaneous eyelid blinks per minute
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.
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.
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.
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.

Full Information

First Posted
April 24, 2018
Last Updated
November 22, 2019
Sponsor
Kuopio University Hospital
Collaborators
Finnsusp Ltd., 4Pharma Ltd., Business Finland
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1. Study Identification

Unique Protocol Identification Number
NCT03569202
Brief Title
Piiloset Trehalose Emulsion Eye Drop Study in Moderate or Severe Dry Eye
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
May 21, 2018 (Actual)
Primary Completion Date
November 8, 2018 (Actual)
Study Completion Date
November 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuopio University Hospital
Collaborators
Finnsusp Ltd., 4Pharma Ltd., Business Finland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. The investigative device is studied in comparison with control eye drops containing hyaluronic acid for up to 30 days.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Emulsion Eye Drops
Arm Type
Experimental
Arm Description
Daily treatment with Piiloset Trehalose Emulsion Eye Drops
Arm Title
Control Eye Drops
Arm Type
Active Comparator
Arm Description
Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)
Intervention Type
Device
Intervention Name(s)
Piiloset Trehalose Emulsion Eye Drops
Intervention Description
Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops 3 times daily
Intervention Type
Device
Intervention Name(s)
Control Eye Drops
Intervention Description
Topical application of preservative-free multidose Hyaluronic Acid Eye Drops 3 times daily
Primary Outcome Measure Information:
Title
Change From Baseline OSDI
Description
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.
Time Frame
From baseline to Day 30 (Part 3)
Title
Change From Baseline Tear Osmolarity
Description
Instrumental assay of tear fluid osmolarity (mOsm/L)
Time Frame
From baseline to Day 30 (Part 3)
Title
Change From Baseline TBUT
Description
Tear film break-up time (TBUT) (s)
Time Frame
From baseline to Day 30 (Part 3)
Secondary Outcome Measure Information:
Title
Change From Baseline Blink Rate
Description
Measurement of spontaneous eyelid blinks per minute
Time Frame
From baseline to Day 30 (Part 3)
Title
Change From Baseline Ocular Protection Index (OPI)
Description
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.
Time Frame
From baseline to Day 30 (Part 3)
Title
Change From Baseline Corneal Staining
Description
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.
Time Frame
From baseline to Day 30 (Part 3)
Title
Change From Baseline Conjunctival (Temporal) Staining
Description
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.
Time Frame
From baseline to Day 30 (Part 3)
Title
Change From Baseline Conjunctival (Nasal) Staining
Description
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.
Time Frame
From baseline to Day 30 (Part 3)
Other Pre-specified Outcome Measures:
Title
Change From Baseline Visual Acuity
Description
Best corrected visual acuity (ETDRS charts 1 & 2, 2000 series)
Time Frame
From baseline to Day 30 (Part 3)
Title
Change From Baseline Conjunctival Redness
Description
Conjunctival redness score is assessed on an ordinal scale of 0 to 4 (IER grading scale): 0 = not existing, 1 = very slight, 2 = slight, 3 = moderate, 4 = severe. Higher score represents more intense redness.
Time Frame
From baseline to Day 30 (Part 3)
Title
Change From Baseline Lid Redness
Description
Eyelid redness score is assessed on an ordinal scale of 0 to 4 (IER grading scale): 0 = not existing, 1 = very slight, 2 = slight, 3 = moderate, 4 = severe. Higher score represents more intense redness.
Time Frame
From baseline to Day 30 (Part 3)
Title
Change From Baseline Intraocular Pressure
Description
Intraocular pressure measured using Goldmann applanation tonometry (mmHg)
Time Frame
From baseline to Day 30 (Part 3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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): A. 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. 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai Kaarniranta, Professor
Organizational Affiliation
Kuopio University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
FI-70200
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31579987
Citation
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.
Results Reference
result

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

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