Dry Eye Treatment With Artificial Tears

Aston University

Status: Completed

Conditions: Dry Eye

Treatments: Other: Liposomal Spray; Other: Carboxymethylcellulose; Other: Hypromellose 0.15%; Other: Hypromellose 0.4%

Study type: Interventional

Funder types: Other

Identifiers

NCT02420834

DOptomEssa

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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50 participants in 4 patient groups

Tear Supplement Hypromellose 0.15%

Experimental group

Description:

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

Treatment:

Other: Hypromellose 0.15%

Tear Supplement Hypromellose 0.4%

Experimental group

Description:

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

Treatment:

Other: Hypromellose 0.4%

Tear Supplement Carboxymethylcellulose

Experimental group

Description:

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

Treatment:

Other: Carboxymethylcellulose

Tear Supplement Liposomal spray

Experimental group

Description:

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

Treatment:

Other: Liposomal Spray