Daily treatment with Piiloset Trehalose Emulsion Eye Drops

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

Daily treatment with Piiloset Trehalose Emulsion Eye Drops
Results are reported for Part 3 only:
Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops on both eyes 3 times a day for 30 days

Emulsion Eye Drops

Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)
Results are reported for Part 3 only:
Topical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days

Control Eye Drops

Total

Sex: Female, Male

Race and Ethnicity Not Collected

Region of Enrollment

Body Weight

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.

Ocular Surface Disease Index (OSDI)

Tear Break-Up Time (TBUT)

Tear osmolarity

Measurement of spontaneous eyelid blinks per minute

Blink rate

Ocular protection index (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.

Ocular protection index (OPI)

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.

Corneal 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.

Conjunctival staining (temporal)

Conjunctival staining (nasal)

Conjunctival redness score is assessed on an ordinal scale of 0 to 4 (Institute for Eye Research (IER) grading scale):
0 = not existing, 1 = very slight, 2 = slight, 3 = moderate, 4 = severe. Higher score represents more intense redness.

Conjunctival redness

Eyelid redness score is assessed on an ordinal scale of 0 to 4 (Institute for Eye Research (IER) grading scale):
0 = not existing, 1 = very slight, 2 = slight, 3 = moderate, 4 = severe. Higher score represents more intense redness.

Lid redness

Intraocular pressure

Ocular surgery, trauma, refractive laser vision correction

Eye infection

Allergy

Current or planned pregnancy and nursing

Change From Baseline OSDI

Instrumental assay of tear fluid osmolarity (mOsm/L)

Change From Baseline Tear Osmolarity

Change From Baseline TBUT

Change From Baseline Blink Rate

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 Ocular Protection Index (OPI)

Change From Baseline Corneal Staining

Change From Baseline Conjunctival (Temporal) Staining

Change From Baseline Conjunctival (Nasal) Staining

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

Change From Baseline Visual Acuity

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.

Change From Baseline Conjunctival Redness

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.

Change From Baseline Lid Redness

Intraocular pressure measured using Goldmann applanation tonometry (mmHg)

Change From Baseline Intraocular Pressure

Instrumental assay of tear fluid osmolarity (mOsm/L) in a hyperosmolar subgroup of participants (mean of eyes ≥308 mOsm/L)

Change From Baseline Tear Osmolarity in Hyperosmolar Participants

Daily treatment with Piiloset Trehalose Emulsion Eye Drops
Piiloset Trehalose Emulsion Eye Drops: Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops
Part 1: on one eye 4 times during one day
Part 2: on one randomized eye 3 times a day for 10 days
Part 3: on both eyes 3 times a day for 30 days

Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)
Control Eye Drops: Topical application of preservative-free multidose Hyaluronic Acid Eye Drops
Part 1: not used
Part 2: on randomized contralateral eye 3 times a day for 10 days
Part 3: on both eyes 3 times a day for 30 days

Part 1

Part 2

Part 3 Dr. Jarmo Laihia, Manager of Clinical & Formulation Development

Daily treatment with Piiloset Trehalose Emulsion Eye Drops
Adverse events are reported for the safety population in all parts of the study, including all randomized subjects who received Piiloset Trehalose Emulsion Eye Drops at least once and from whom at least one safety measurement was obtained after randomization.

Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)
Adverse events are reported for the safety population in all parts of the study, including all randomized subjects who received Hyaluronic Acid Eye Drops at least once and from whom at least one safety measurement was obtained after randomization.

Dry Eye Syndrome

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

Piiloset Trehalose Emulsion Eye Drops

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

Department of Ophthalmology, Kuopio University Hospital

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

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

Kai Kaarniranta

MD, PhD, Professor

Kuopio University Hospital

Finnsusp Ltd.

4Pharma Ltd.

Business Finland

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.

Participants will receive 100 g of bread with 70 g of butter (high saturated fat meal) added with 15ml of Sacha Inchi oil and 125ml of coffee with 10g of sugar

Participants will receive 100 g of bread with 70 g of butter (high saturated fat meal) and 125ml of coffee with 10g of sugar

Cardiovascular Diseases

High fat meal with Sacha Inchi

high saturated fat meal

University of San Buenaventura

Effectiveness of Sacha Inchi Supplementation on Postprandial Inflammation

Effect of Supplementation of a High-fat Meal With Sacha Inchi Oil on Postprandial Metabolic and Inflammatory Responses in Adults With Low Physical Activity and Without Abdominal Obesity

plukenetia volubilis/inflammation

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

Effectiveness of Sacha Inchi Supplementation on Postprandial Inflammation

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