NCT03569202

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

Completed NA Results posted Last updated 13 December 2019

What this trial tests

NA trial testing Piiloset Trehalose Emulsion Eye Drops in Dry Eye Syndrome in 64 participants. Completed in 8 November 2018.

Timeline

21 May 2018

Primary endpoint
8 November 2018

8 November 2018

Quick facts

Lead sponsor	Kuopio University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	64
Start date	21 May 2018
Primary completion	8 November 2018
Estimated completion	8 November 2018
Sites	1 location across Finland

Drugs / interventions tested

• Piiloset Trehalose Emulsion Eye Drops
• Control Eye Drops

Conditions studied

• Dry Eye Syndrome — all drugs for Dry Eye Syndrome →

Sponsor

Kuopio University Hospital

Who can join

Adults 18 to 80, any sex, with Dry Eye Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline OSDI Primary · 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.

Group	Value	95% CI
Emulsion Eye Drops	-24.64	± 16.186
Control Eye Drops	-26.53	± 14.620

Change From Baseline Tear Osmolarity Primary · From baseline to Day 30 (Part 3)

Instrumental assay of tear fluid osmolarity (mOsm/L)

Group	Value	95% CI
Emulsion Eye Drops	-4.75	± 16.224
Control Eye Drops	-1.77	± 21.531

Change From Baseline TBUT Primary · From baseline to Day 30 (Part 3)

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

Group	Value	95% CI
Emulsion Eye Drops	1.71	± 3.424
Control Eye Drops	0.87	± 1.809

Change From Baseline Blink Rate Secondary · From baseline to Day 30 (Part 3)

Measurement of spontaneous eyelid blinks per minute

Group	Value	95% CI
Emulsion Eye Drops	0.02	± 8.721
Control Eye Drops	-2.15	± 10.161

Change From Baseline Ocular Protection Index (OPI) Secondary · From baseline to Day 30 (Part 3)

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.

Group	Value	95% CI
Emulsion Eye Drops	0.56	± 1.078
Control Eye Drops	0.05	± 0.680

Change From Baseline Corneal Staining Secondary · From baseline to Day 30 (Part 3)

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.

Group	Value	95% CI
Emulsion Eye Drops	-0.38	± 0.695
Control Eye Drops	-0.22	± 0.522

Change From Baseline Conjunctival (Temporal) Staining Secondary · From baseline to Day 30 (Part 3)

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.

Group	Value	95% CI
Emulsion Eye Drops	-0.19	± 0.507
Control Eye Drops	-0.02	± 0.810

Change From Baseline Conjunctival (Nasal) Staining Secondary · From baseline to Day 30 (Part 3)

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.

Group	Value	95% CI
Emulsion Eye Drops	-0.27	± 0.608
Control Eye Drops	-0.12	± 0.666

Change From Baseline Visual Acuity Secondary · From baseline to Day 30 (Part 3)

Best corrected visual acuity (ETDRS charts 1 \& 2, 2000 series)

Group	Value	95% CI
Emulsion Eye Drops	-0.03	± 0.071
Control Eye Drops	-0.04	± 0.080

Change From Baseline Conjunctival Redness Secondary · From baseline to Day 30 (Part 3)

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.

Group	Value	95% CI
Emulsion Eye Drops	-0.46	± 0.647
Control Eye Drops	-0.27	± 0.652

Change From Baseline Lid Redness Secondary · From baseline to Day 30 (Part 3)

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.

Group	Value	95% CI
Emulsion Eye Drops	-0.37	± 0.672
Control Eye Drops	-0.19	± 0.549

Change From Baseline Intraocular Pressure Secondary · From baseline to Day 30 (Part 3)

Intraocular pressure measured using Goldmann applanation tonometry (mmHg)

Group	Value	95% CI
Emulsion Eye Drops	-0.12	± 1.705
Control Eye Drops	-0.42	± 1.653

Adverse events — posted to ClinicalTrials.gov

Time frame: Part 1: 1 day; Part 2: 10 days; Part 3: 30 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Emulsion Eye Drops

Serious: 0/38 (0%)

Deaths: 0/38

Control Eye Drops

Serious: 0/35 (0%)

Deaths: 0/35

Other adverse events (1 terms — click to expand)

Reaction	System	Emulsion Eye Drops	Control Eye Drops
AE (adverse event)	Skin and subcutaneous tissue disorders	—	—

Data from ClinicalTrials.gov NCT03569202 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Omega-3 and omega-6 polyunsaturated fatty acids for dry eye disease.
   Downie LE, Ng SM, Lindsley KB, Akpek EK. · · 2019 · cited 59× · PMID 31847055 · DOI 10.1002/14651858.cd011016.pub2
2. Artificial Tears: A Systematic Review.
   Semp DA, Beeson D, Sheppard AL, Dutta D, et al · · 2023 · cited 51× · PMID 36647552 · DOI 10.2147/opto.s350185
3. Disease aetiology-based design of multifunctional microemulsion eye drops for moderate or severe dry eye: a randomized, quadruple-masked and active-controlled clinical trial.
   Laihia J, Järvinen R, Wylęgała E, Kaarniranta K. · · 2020 · cited 17× · PMID 31579987 · DOI 10.1111/aos.14252
4. Testing Mitochondrial-Targeted Drugs in iPSC-RPE from Patients with Age-Related Macular Degeneration.
   Ebeling MC, Geng Z, Stahl MR, Kapphahn RJ, et al · · 2022 · cited 16× · PMID 35056119 · DOI 10.3390/ph15010062