CompletedNot Applicable

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

Finland64 participantsStarted 2018-05-21

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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):
. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline OSDI

Timeframe: From baseline to Day 30 (Part 3)

Change From Baseline Tear Osmolarity

Timeframe: From baseline to Day 30 (Part 3)

Change From Baseline TBUT

Timeframe: From baseline to Day 30 (Part 3)

Trial details

NCT IDNCT03569202

SponsorKuopio University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-11-08

Results submitted2019-10-11

View on ClinicalTrials.gov More Dry Eye Syndrome trials

Plain-language summary

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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):
. 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.

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria