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Tear Osmolarity Clinical Utility in Dry Eye Disease

Primary Purpose

Dry Eye

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Tear supplement
Tear supplement 2
Omega 3 nutrition supplement
Eye bag
Saline
Sponsored by
Aston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Dry Eye Symptoms SPEED >8

Exclusion Criteria:

  • Unable to participate in 90 days therapy
  • Allergic to therapy
  • On medication known to affect ocular surface / tear film
  • Had ocular trauma, infection or surgery
  • Diagnosed with a medical condition known to affect ocular surface / tear film

Sites / Locations

  • Robert Frith Opticians
  • Robert Frith Opticians
  • Robert Frith Opticians
  • Robert Frith Opticians
  • Black & Lizars Optometrists
  • Black & Lizars Optometrists

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Control

Hypromellose - standard treatment

Combination treatment

Arm Description

Minims Saline (Preservative Free) lubricant eye drops - daily for 90 days

Tear Supplement: Hypromellose 0.3% eye drops - daily for 90 days

Tear Supplement 2: Hylo-Forte 0.2% Sodium Hyaluronate eye drops, Omega 3 nutrition supplement: Omega-3 tablets, Eye bag: TranquilEyes Moist Heat Lid Compresses - Daily for 90 days;

Outcomes

Primary Outcome Measures

Osmolarity change
Salt balance in tears measured with the Tearlab

Secondary Outcome Measures

Tear break-up time change
Tear stability following a blink
Corneal staining change
Fluorescein dye applied to the ocular surface and observed with blue light and a yellow filter to observe staining fluorescence
Meibomian gland change
Grading of meibomian glands using Oxford scale
Tear Meniscus Height
Height of tear meniscus along the lower lid margin observed through a slit-lamp microscope
SPEED Questionnaire change
Dry eye symptomology questionnaire

Full Information

First Posted
April 10, 2015
Last Updated
January 9, 2019
Sponsor
Aston University
Collaborators
TearLab Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02417116
Brief Title
Tear Osmolarity Clinical Utility in Dry Eye Disease
Official Title
Tear Osmolarity Clinical Utility in Dry Eye Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aston University
Collaborators
TearLab Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Millions of people suffer from dry eye disease, causing symptoms such as redness, burning, feeling of sand or grit in the eye and light sensitivity. Dry eye disease occurs when your eyes do not produce enough tears or produce poor quality tears. This can happen for a number of reasons, including aging, hormonal changes in women and side effects of diseases or medications. It is now possible to objectively measure the degree of dry eye disease by collecting a tiny sample of tears from the corner of the eye and then measuring the amount of salt in the tears (termed osmolarity). We aim to establish the overall levels of raised and normal tear osmolarity in people presenting to the eye clinic with complaints of dry eye, and relate this to other factors such as symptoms, topical and nutritional medication and dry eye treatment.
Detailed Description
This study will investigate the efficacy of two treatment non-pharmaceutical therapies (tear drop alone, tear drop combined with omega 3 nutritional supplement and warm compresses) for dry eye reporting patients against a control (saline) over a 3 month period. A relatively new clinical measure (osmolarity) will be performed alongside traditional tear film volume, tear film stability, gland integrity and ocular surface damage measures to determine how this influences symptomatic complaints.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Minims Saline (Preservative Free) lubricant eye drops - daily for 90 days
Arm Title
Hypromellose - standard treatment
Arm Type
Active Comparator
Arm Description
Tear Supplement: Hypromellose 0.3% eye drops - daily for 90 days
Arm Title
Combination treatment
Arm Type
Active Comparator
Arm Description
Tear Supplement 2: Hylo-Forte 0.2% Sodium Hyaluronate eye drops, Omega 3 nutrition supplement: Omega-3 tablets, Eye bag: TranquilEyes Moist Heat Lid Compresses - Daily for 90 days;
Intervention Type
Other
Intervention Name(s)
Tear supplement
Other Intervention Name(s)
Hypermellose 0.3% eye drop
Intervention Description
Application as required to improve comfort
Intervention Type
Other
Intervention Name(s)
Tear supplement 2
Other Intervention Name(s)
Hylo-Forte 0.2% Sodium Hyaluronate eye drop
Intervention Description
Application as required to improve comfort
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega 3 nutrition supplement
Other Intervention Name(s)
Scope Ophthalmics Omega Eye
Intervention Description
Taken each day
Intervention Type
Device
Intervention Name(s)
Eye bag
Other Intervention Name(s)
TranquilEyes Moist Heat Lid
Intervention Description
Applied following microwave heating to closed eyelids for 5 minutes each day
Intervention Type
Other
Intervention Name(s)
Saline
Other Intervention Name(s)
Minim sodium chloride 0.9% unpreserved
Intervention Description
Application as required to improve comfort
Primary Outcome Measure Information:
Title
Osmolarity change
Description
Salt balance in tears measured with the Tearlab
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Tear break-up time change
Description
Tear stability following a blink
Time Frame
3 months
Title
Corneal staining change
Description
Fluorescein dye applied to the ocular surface and observed with blue light and a yellow filter to observe staining fluorescence
Time Frame
3 months
Title
Meibomian gland change
Description
Grading of meibomian glands using Oxford scale
Time Frame
3 months
Title
Tear Meniscus Height
Description
Height of tear meniscus along the lower lid margin observed through a slit-lamp microscope
Time Frame
3 months
Title
SPEED Questionnaire change
Description
Dry eye symptomology questionnaire
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Dry Eye Symptoms SPEED >8 Exclusion Criteria: Unable to participate in 90 days therapy Allergic to therapy On medication known to affect ocular surface / tear film Had ocular trauma, infection or surgery Diagnosed with a medical condition known to affect ocular surface / tear film
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Wolffsohn, BSc MBA PhD
Organizational Affiliation
Aston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert Frith Opticians
City
Shaftesbury
State/Province
Dorest
ZIP/Postal Code
SP7 8AR
Country
United Kingdom
Facility Name
Robert Frith Opticians
City
Blandford Forum
State/Province
Dorset
ZIP/Postal Code
DT11 8AR
Country
United Kingdom
Facility Name
Robert Frith Opticians
City
Gillingham
State/Province
Dorset
ZIP/Postal Code
SP8 4AA
Country
United Kingdom
Facility Name
Robert Frith Opticians
City
Twickenham
State/Province
Middlesex
ZIP/Postal Code
TW1 4BW
Country
United Kingdom
Facility Name
Black & Lizars Optometrists
City
Ayr
ZIP/Postal Code
KA7 1UL
Country
United Kingdom
Facility Name
Black & Lizars Optometrists
City
Glasgow
ZIP/Postal Code
G46 6JB
Country
United Kingdom

12. IPD Sharing Statement

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Tear Osmolarity Clinical Utility in Dry Eye Disease

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