Dry Eye Treatment With Artificial Tears

Not Applicable

Completed

• Conditions: Dry Eye
• Interventions: Other: Hypromellose 0.15%; Other: Hypromellose 0.4%; Other: Liposomal Spray; Other: Carboxymethylcellulose

• Registration Number: NCT02420834
• Lead Sponsor: Aston University

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-10
• Study First Submitted QC: 2015-04-15
• Study First Posted: 2015-04-20
• Status Verified: 2019-01
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Last Update Submitted: 2019-01-09
• Last Update Posted: 2019-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• subjective symptoms indicative of dry eye

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tear Supplement Hypromellose 0.15%	Hypromellose 0.15%	Preservative free Hypromellose Eye Drops BP 0.15% applied as required for 1 month
Tear Supplement Hypromellose 0.4%	Hypromellose 0.4%	Preservative free Hypromellose Eye Drops BP 0.4% applied as required for 1 month
Tear Supplement Liposomal spray	Liposomal Spray	Preservative free Phospholipid liposomal spray (Tears Again) applied as required for 1 month
Tear Supplement Carboxymethylcellulose	Carboxymethylcellulose	Tear Supplement 3: Preservative free 0.25% Carboxymethylcellulose, electrolyte balanced (Theratears) applied as required for 1 month

Primary Outcome Measures

Name	Time	Method
Symptoms	4 months	Short questionnaire (Ocular Surface Disease Index)

Secondary Outcome Measures

Name	Time	Method
Ocular Surface Staining	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
Phenol Red Test	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
lid parallel conjunctival folds	4 months	Lid parallel conjunctival folds will counted as observed with a slit lamp biomicroscope and timed/graded
Non-invasive break-up time	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
Tear meniscus height	4 months	Tear meniscus height will be assessed in millimetres by comparing to the slit height adjustment of a slit lamp biomicroscope.

Trial Locations

Locations (1)

Specsavers; 🇬🇧 Thornton, Cleveleys, United Kingdom