NCT02683382

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 17, 2016

Completed
13 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

October 12, 2016

Status Verified

October 1, 2016

Enrollment Period

3 months

First QC Date

February 2, 2016

Last Update Submit

October 11, 2016

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (6)

  • Change in symptoms of dry eye: Ocular Surface Disease Index (OSDI), scores of dryness, burning and foreign body sensation of eyes

    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)

    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)

    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)

    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

    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)

    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)

    Part 2: change from baseline to 9 days; Part 3: change from baseline to 45 days

Study Arms (3)

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.

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.

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.

Interventions

Moisturizing Eye Product in Liquid FormulaDEVICE

Moisturizing Eye Product in Liquid Formula for dry eyes and skin around the eyes

Moisturizing Eye Product (product in development)Moisturizing Eye Product, Comparison

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dry eye symptoms OSDI score 20 or higher
  • Dryness, burning or foreign body sensation moderate or higher

You may not qualify if:

  • Severe eye diseases
  • Known allergy to any of the ingredients of the product
  • Laser surgery of eyes during the last year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turun Silmäexpertit Oy

Turku, Finland

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Minna Sandberg-Lall, MD

    Turun Silmäexpertit Oy, Turku, Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ph.D., R&D Manager

Study Record Dates

First Submitted

February 2, 2016

First Posted

February 17, 2016

Study Start

March 1, 2016

Primary Completion

June 1, 2016

Study Completion

July 1, 2016

Last Updated

October 12, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)