Dry Eye Treatment With Artificial Tears

NCT02420834 — Not applicable, Completed, 50 participants, Aston University

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Registry	NCT02420834
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: triple, treatment
Enrollment	50 (Actual)
Sponsor	Aston University (Other)
Conditions	Dry Eye
Interventions	Hypromellose 0.15%, Hypromellose 0.4%, Carboxymethylcellulose, Liposomal Spray (Other)
Dates	start 2015-04-01, primary completion 2019-01-01, completion 2019-01-01, first posted 2015-04-20, last updated 2019-01-10
Locations	1 site in United Kingdom

-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.

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+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.

+Arms and interventions

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

Hypromellose 0.15% (Other), also known as Hypromellose is also sold as Isopto plain eye drops: Tear supplement to be taken as required to relieve symptoms
Hypromellose 0.4% (Other), also known as Hypromellose is also sold as Isopto plain eye drops: Tear supplement to be taken as required to relieve symptoms
Carboxymethylcellulose (Other), also known as Theratears: Tear supplement to be taken as required to relieve symptoms
Liposomal Spray (Other), also known as Tears Again: Tear supplement o be taken as required to relieve symptoms

+Outcome measures

Primary outcomes

Symptoms [4 months]: Short questionnaire (Ocular Surface Disease Index)

Secondary outcomes

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.
lid parallel conjunctival folds [4 months]: Lid parallel conjunctival folds will counted as observed with a slit lamp biomicroscope and timed/graded
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

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Specsavers	Thornton, Cleveleys	United Kingdom

+Investigators

James S Wolffsohn, BSc PhD, Principal investigator, Aston University