Dry Eye SyndromesSDENCT02683382
Effects of a Moisturizing Product on Dry Eye and Skin
A study testing Moisturizing Eye Product in Liquid Formula in people with Dry Eye Syndromes, run by Petra Larmo at 1 site in Finland.
Trial summary
Dry eye is a common syndrome associated with symptoms of dryness, burning, itching and grittiness of eyes. The objective of this study is to investigate the effects of a moisturizing product in liquid formula on symptoms and signs of dry eye and on skin around the eyes. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Moisturizing Eye Product in Liquid Formula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2016to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Dry eye symptoms OSDI score 20 or higher
- Dryness, burning or foreign body sensation moderate or higher
Who cannot join
- Severe eye diseases
- Known allergy to any of the ingredients of the product
- Laser surgery of eyes during the last year
Trial locations and contacts
1 site in 1 country.
About this study
Dry eye is a common syndrome associated with symptoms of dryness, burning, itching and grittiness of eyes. The objective of this study is to investigate the effects of a moisturizing product in liquid formula on symptoms and signs of dry eye and on skin around the eyes.
- Conditions
- Dry Eye Syndromes
- Being tested
- Moisturizing Eye Product in Liquid Formula
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moisturizing Eye Product in Liquid FormulaDevice
Moisturizing Eye Product in Liquid Formula for dry eyes and skin around the eyes
| Study group | Role | What they receive |
|---|---|---|
| Moisturizing Eye Product (product in development) | Experimental | Moisturizing eye product in liquid form (medical device product in development). Part 1 of the study: Administered to both eyes 4 times/day for 1 day. Part 2: to one eye 4 times/day for 9 days. Part 3: to one eye 4 times/day for 45 days. Parts 2 \& 3: treatment eyes randomized. Receives: Device: Moisturizing Eye Product in Liquid Formula |
| Moisturizing Eye Product, Comparison | Active comparator | Moisturizing eye product in liquid form (medical device CE-marked). Part 2 of the study: Administered to one eye 4 times/day for 9 days. Treatment eyes randomized. Receives: Device: Moisturizing Eye Product in Liquid Formula |
| No treatment | No intervention | Part 3 of the study: other eye is a control eye with no treatment for 45 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in symptoms of dry eye: Ocular Surface Disease Index (OSDI), scores of dryness, burning and foreign body sensation of eyes
Measured: Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days
Change in tear film osmolarity (mOsm/L)
Measured: Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days
Change in tear film break-up time (s)
Measured: Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days
Change in tear secretion, Schirmer test (mm/min)
Measured: Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days
Change in signs of irritation of eyes, scoring by an eye specialist
Measured: Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days
Change in transepidermal water loss from skin around the eyes (g/m2h)
Measured: Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days
Secondary outcomes (1)
Change in other symptoms of dry eye: soreness, grittiness, watery eyes, redness, blurring of eyes (daily symptom logbooks: scoring in scale from 0 to 3)
Measured: Part 2: change from baseline to 9 days; Part 3: change from baseline to 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Petra Larmo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Turun Silmäexpertit Oy, Turku, Finland, The Finnish Funding Agency for Technology and Innovation, Finnsusp Oy, Lieto, Finland
- Responsible party
- Sponsor-investigator, Petra Larmo, Aromtech Ltd.
- Investigators
- Minna Sandberg-Lall, MD, Principal investigator, Turun Silmäexpertit Oy, Turku, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683382
- Sponsor's protocol ID
- SDE
- Acronym
- SDE
- Status last verified
- Oct 2016
- First submitted
- 2 Feb 2016
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Moisturizing Product on Dry Eye and Skin
- ClinicalTrials.gov ID
- NCT02683382
- Acronym / sponsor ID
- SDE / SDE
- Conditions
- Dry Eye Syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Petra LarmoIndustry (pharma, biotech, devices)
- Collaborators
- Turun Silmäexpertit Oy, Turku, Finland, The Finnish Funding Agency for Technology and Innovation, Finnsusp Oy, Lieto, Finland
- Study start
- Mar 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 17 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dry eye is a common syndrome associated with symptoms of dryness, burning, itching and grittiness of eyes. The objective of this study is to investigate the effects of a moisturizing product in liquid formula on symptoms and signs of dry eye and on skin around the eyes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Moisturizing Eye Product (product in development) | Experimental | Device: Moisturizing Eye Product in Liquid FormulaMoisturizing eye product in liquid form (medical device product in development). Part 1 of the study: Administered to both eyes 4 times/day for 1 day. Part 2: to one eye 4 times/day for 9 days. Part 3: to one eye 4 times/day for 45 days. Parts 2 \& 3: treatment eyes randomized. |
| Moisturizing Eye Product, Comparison | Active comparator | Device: Moisturizing Eye Product in Liquid FormulaMoisturizing eye product in liquid form (medical device CE-marked). Part 2 of the study: Administered to one eye 4 times/day for 9 days. Treatment eyes randomized. |
| No treatment | No intervention | –Part 3 of the study: other eye is a control eye with no treatment for 45 days. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Dry eye symptoms OSDI score 20 or higher
- Dryness, burning or foreign body sensation moderate or higher
Key exclusion criteria (3 listed)
- Severe eye diseases
- Known allergy to any of the ingredients of the product
- Laser surgery of eyes during the last year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moisturizing Eye Product in Liquid FormulaMoisturizing Eye Product in Liquid Formula for dry eyes and skin around the eyes | Device | Moisturizing Eye Product (product in development), Moisturizing Eye Product, Comparison |
Primary outcome
Change in symptoms of dry eye: Ocular Surface Disease Index (OSDI), scores of dryness, burning and foreign body sensation of eyes
Time frame: Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days
Change in tear film osmolarity (mOsm/L)
Time frame: Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days
Change in tear film break-up time (s)
Time frame: Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days
Change in tear secretion, Schirmer test (mm/min)
Time frame: Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days
Change in signs of irritation of eyes, scoring by an eye specialist
Time frame: Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days
Change in transepidermal water loss from skin around the eyes (g/m2h)
Time frame: Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days
1 secondary outcome
Change in other symptoms of dry eye: soreness, grittiness, watery eyes, redness, blurring of eyes (daily symptom logbooks: scoring in scale from 0 to 3)
Time frame: Part 2: change from baseline to 9 days; Part 3: change from baseline to 45 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minna Sandberg-Lall, MD principal investigator
Turun Silmäexpertit Oy, Turku, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moisturizing Eye Product in Liquid Formula in people with Dry Eye Syndromes, run by Petra Larmo at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in symptoms of dry eye: Ocular Surface Disease Index (OSDI), scores of dryness, burning and foreign body sensation of eyes (time frame: Part 1: baseline, 2, 4, and 6 hours. Part 2: baseline, 1 day, 3 and 9 days. Part 3: baseline and 45 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2016.