N/A
Completed N=3
Piiloset Trehalose Emulsion Eye Drop Study in Moderate or Severe Dry Eye
Source: ClinicalTrials.gov NCT03569202 ↗Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcomePrimary: Change From Baseline OSDI — -24.64; -26.53 units on a scale — p=0.662
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline OSDI |
-24.64; -26.53 | 0.662 |
| PRIMARY Change From Baseline Tear Osmolarity |
-4.75; -1.77 | 0.575 |
| PRIMARY Change From Baseline TBUT |
1.71; 0.87 | 0.271 |
| SECONDARY Change From Baseline Blink Rate |
0.02; -2.15 | 0.412 |
| SECONDARY Change From Baseline Ocular Protection Index (OPI) |
0.56; 0.05 | 0.047 sig |
| SECONDARY Change From Baseline Corneal Staining |
-0.38; -0.22 | 0.447 |
| SECONDARY Change From Baseline Conjunctival (Temporal) Staining |
-0.19; -0.02 | 0.522 |
| SECONDARY Change From Baseline Conjunctival (Nasal) Staining |
-0.27; -0.12 | 0.590 |
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.
Data sourced from ClinicalTrials.gov (NCT03569202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.