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

NCT03569202 | Completed Results

• 1 other identifier: 5503762
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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.

  From baseline to Day 30 (Part 3)

• Change From Baseline Tear Osmolarity

  Instrumental assay of tear fluid osmolarity (mOsm/L)

  From baseline to Day 30 (Part 3)

• Change From Baseline TBUT

  Tear film break-up time (TBUT) (s)

  From baseline to Day 30 (Part 3)

Secondary Outcomes (5)

• Change From Baseline Blink Rate

  From baseline to Day 30 (Part 3)

• Change From Baseline Ocular Protection Index (OPI)

  From baseline to Day 30 (Part 3)

• Change From Baseline Corneal Staining

  From baseline to Day 30 (Part 3)

• Change From Baseline Conjunctival (Temporal) Staining

  From baseline to Day 30 (Part 3)

• Change From Baseline Conjunctival (Nasal) Staining

  From baseline to Day 30 (Part 3)

Other Outcomes (4)

• Change From Baseline Visual Acuity

  From baseline to Day 30 (Part 3)

• Change From Baseline Conjunctival Redness

  From baseline to Day 30 (Part 3)

• Change From Baseline Lid Redness

  From baseline to Day 30 (Part 3)

Study Arms (2)

Emulsion Eye Drops

EXPERIMENTAL

Daily treatment with Piiloset Trehalose Emulsion Eye Drops

Device: Piiloset Trehalose Emulsion Eye Drops

Control Eye Drops

ACTIVE COMPARATOR

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

Device: Control Eye Drops

Interventions

Piiloset Trehalose Emulsion Eye Drops DEVICE

Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops 3 times daily

Emulsion Eye Drops

Control Eye Drops DEVICE

Topical application of preservative-free multidose Hyaluronic Acid Eye Drops 3 times daily

Control Eye Drops

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kuopio University Hospital: lead
• Finnsusp Ltd.: collaborator
• 4Pharma Ltd.: collaborator
• Business Finland: collaborator

Study Sites (1)

Department of Ophthalmology, Kuopio University Hospital

Kuopio, FI-70200, Finland

Location

Related Publications (1)

• 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.

  PMID: 31579987 RESULT

MeSH Terms

Conditions

Dry Eye Syndromes; Lymphoma, Follicular; Lacerations

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Wounds and Injuries

Results Point of Contact

• Title: Dr. Jarmo Laihia, Manager of Clinical & Formulation Development
• Organization: Finnsusp Ltd.

jarmo.laihia@piiloset.fi

358 50 377 1212

Study Officials

• Kai Kaarniranta, Professor

  Kuopio University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: June 26, 2018
• Study Start: May 21, 2018
• Primary Completion: November 8, 2018
• Study Completion: November 8, 2018
• Last Updated: December 13, 2019
• Results First Posted: December 13, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)