NCT02420834

Brief Summary

Dry eye is a chronic irritating eye condition that affects many people, caused by poor tear quality and insufficient quantity. Treatments are traditionally in the form of artificial tears applied to the ocular surface. However, there is little evidence in the scientific literature that demonstrates their efficacy relative compared to each other, nor how to decide which one might be most effective for an individual patient. Therefore the investigators aim to examine the efficacy of different classes of artificial tears (those designed to increase viscosity, reduce evaporation or to mimic the component balance of the natural tears). In addition, the investigators also aim to determine how the treatment preferred by an individual could potentially have been predicted from their baseline condition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 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

Study Start

First participant enrolled

April 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 20, 2015

Completed
3.7 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

3.8 years

First QC Date

April 10, 2015

Last Update Submit

January 9, 2019

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • Symptoms

    Short questionnaire (Ocular Surface Disease Index)

    4 months

Secondary Outcomes (5)

  • Non-invasive break-up time

    4 months

  • Tear meniscus height

    4 months

  • lid parallel conjunctival folds

    4 months

  • Ocular Surface Staining

    4 months

  • Phenol Red Test

    4 months

Study Arms (4)

Tear Supplement Hypromellose 0.15%

EXPERIMENTAL

Preservative free Hypromellose Eye Drops BP 0.15% applied as required for 1 month

Other: Hypromellose 0.15%

Tear Supplement Hypromellose 0.4%

EXPERIMENTAL

Preservative free Hypromellose Eye Drops BP 0.4% applied as required for 1 month

Other: Hypromellose 0.4%

Tear Supplement Carboxymethylcellulose

EXPERIMENTAL

Tear Supplement 3: Preservative free 0.25% Carboxymethylcellulose, electrolyte balanced (Theratears) applied as required for 1 month

Other: Carboxymethylcellulose

Tear Supplement Liposomal spray

EXPERIMENTAL

Preservative free Phospholipid liposomal spray (Tears Again) applied as required for 1 month

Other: Liposomal Spray

Interventions

Hypromellose 0.15%OTHER

Tear supplement to be taken as required to relieve symptoms

Also known as: Hypromellose is also sold as Isopto plain eye drops
Tear Supplement Hypromellose 0.15%
Hypromellose 0.4%OTHER

Tear supplement to be taken as required to relieve symptoms

Also known as: Hypromellose is also sold as Isopto plain eye drops
Tear Supplement Hypromellose 0.4%
CarboxymethylcelluloseOTHER

Tear supplement to be taken as required to relieve symptoms

Also known as: Theratears
Tear Supplement Carboxymethylcellulose
Liposomal SprayOTHER

Tear supplement o be taken as required to relieve symptoms

Also known as: Tears Again
Tear Supplement Liposomal spray

Eligibility Criteria

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

You may qualify if:

  • subjective symptoms indicative of dry eye

You may not qualify if:

  • Diabetes
  • Sjögren's Syndrome
  • recent ocular infection
  • hay fever
  • used any eye drops or ocular medications,
  • were currently on medications known to affect the eyes
  • wore contact lenses
  • were pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Specsavers

Thornton, Cleveleys, FY5 1AJ, United Kingdom

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Carboxymethylcellulose Sodium

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

MethylcelluloseCelluloseGlucansPolysaccharidesCarbohydrates

Study Officials

  • James S Wolffsohn, BSc PhD

    Aston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2015

First Posted

April 20, 2015

Study Start

April 1, 2015

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

January 10, 2019

Record last verified: 2019-01

Locations

GB(1)