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OpenTrials
Completed

NCT Number: NCT02420834

Dry Eye Treatment With Artificial Tears

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Specsavers

Thornton, Cleveleys, FY5 1AJ, United Kingdom

About this study

The efficacy of different classes of artificial tears (non-pharmaceutical) will be examined in patients that report dry eyes by prescribing each category of treatment [0.40% Sodium Hyaluronate (Clinitas Soothe), 0.15% Sodium Hyaluronate (Hyabak), 0.25% Carboxymethylcellulose, electrolyte balanced (Theratears), and Phospholipid liposomal spray (Tears Again)] for a month in turn following a short wash-out period and to examine their tear film and ocular surface after each one.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • subjective symptoms indicative of dry eye

Exclusion criteria

  • 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.

Treatment and study plan

Hypromellose 0.15%

Other

Tear supplement to be taken as required to relieve symptoms

Other names: Hypromellose is also sold as Isopto plain eye drops

Hypromellose 0.4%

Other

Tear supplement to be taken as required to relieve symptoms

Other names: Hypromellose is also sold as Isopto plain eye drops

Carboxymethylcellulose

Other

Tear supplement to be taken as required to relieve symptoms

Other names: Theratears

Liposomal Spray

Other

Tear supplement o be taken as required to relieve symptoms

Other names: Tears Again

Primary outcomes

  1. Symptoms

    Time frame: 4 months

    Short questionnaire (Ocular Surface Disease Index)

Secondary outcomes

  1. Non-invasive break-up time

    Time frame: 4 months

    Tear stability will be assessed using the Purkinje reflection from the tear film on the ocular surface recording the time (in seconds) that the reflection is first distorted, observed with a slit lamp biomicroscope

  2. Tear meniscus height

    Time frame: 4 months

    Tear meniscus height will be assessed in millimetres by comparing to the slit height adjustment of a slit lamp biomicroscope.

  3. lid parallel conjunctival folds

    Time frame: 4 months

    Lid parallel conjunctival folds will counted as observed with a slit lamp biomicroscope and timed/graded

  4. Ocular Surface Staining

    Time frame: 4 months

    Ocular surface staining with fluorescein and lissamine green dyes will be observed with a slitlamp biomicroscope and graded using the Efron grading scale

  5. Phenol Red Test

    Time frame: 4 months

    Tear volume will be quantified in millimetres after 15s with the tip inserted in the lower tear meniscus from the wetting height of a phenol red impregnated strip inserted in the lower fornix for 15 seconds

Sponsors and collaborators

Lead sponsor

Aston University

Other

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Apr 20, 2015
Registry last updated
Jan 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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