NCT02417116

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

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

April 10, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 15, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

January 10, 2019

Status Verified

January 1, 2019

Enrollment Period

3.6 years

First QC Date

April 10, 2015

Last Update Submit

January 9, 2019

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • Osmolarity change

    Salt balance in tears measured with the Tearlab

    3 months

Secondary Outcomes (5)

  • Tear break-up time change

    3 months

  • Corneal staining change

    3 months

  • Meibomian gland change

    3 months

  • Tear Meniscus Height

    3 months

  • SPEED Questionnaire change

    3 months

Study Arms (3)

Control

PLACEBO COMPARATOR

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

Other: Saline

Hypromellose - standard treatment

ACTIVE COMPARATOR

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

Other: Tear supplement

Combination treatment

ACTIVE COMPARATOR

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;

Other: Tear supplement 2Dietary Supplement: Omega 3 nutrition supplementDevice: Eye bag

Interventions

Tear supplementOTHER

Application as required to improve comfort

Also known as: Hypermellose 0.3% eye drop
Hypromellose - standard treatment
Tear supplement 2OTHER

Application as required to improve comfort

Also known as: Hylo-Forte 0.2% Sodium Hyaluronate eye drop
Combination treatment
Omega 3 nutrition supplementDIETARY_SUPPLEMENT

Taken each day

Also known as: Scope Ophthalmics Omega Eye
Combination treatment
Eye bagDEVICE

Applied following microwave heating to closed eyelids for 5 minutes each day

Also known as: TranquilEyes Moist Heat Lid
Combination treatment
SalineOTHER

Application as required to improve comfort

Also known as: Minim sodium chloride 0.9% unpreserved
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dry Eye Symptoms SPEED \>8

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Robert Frith Opticians

Shaftesbury, Dorest, SP7 8AR, United Kingdom

Location

Robert Frith Opticians

Blandford Forum, Dorset, DT11 8AR, United Kingdom

Location

Robert Frith Opticians

Gillingham, Dorset, SP8 4AA, United Kingdom

Location

Robert Frith Opticians

Twickenham, Middlesex, TW1 4BW, United Kingdom

Location

Black & Lizars Optometrists

Ayr, KA7 1UL, United Kingdom

Location

Black & Lizars Optometrists

Glasgow, G46 6JB, United Kingdom

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Ophthalmic SolutionsSodium Chloride

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • James Wolffsohn, BSc MBA PhD

    Aston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2015

First Posted

April 15, 2015

Study Start

June 1, 2015

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

January 10, 2019

Record last verified: 2019-01

Locations

GB(6)