Dry Eye Treatment With Artificial Tears

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2019-01-31

Brief Summary

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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

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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.

Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Tear Supplement Hypromellose 0.15%

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

Group Type EXPERIMENTAL

Hypromellose 0.15%

Intervention Type OTHER

Tear supplement to be taken as required to relieve symptoms

Tear Supplement Hypromellose 0.4%

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

Group Type EXPERIMENTAL

Hypromellose 0.4%

Intervention Type OTHER

Tear supplement to be taken as required to relieve symptoms

Tear Supplement Carboxymethylcellulose

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

Group Type EXPERIMENTAL

Carboxymethylcellulose

Intervention Type OTHER

Tear supplement to be taken as required to relieve symptoms

Tear Supplement Liposomal spray

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

Group Type EXPERIMENTAL

Liposomal Spray

Intervention Type OTHER

Tear supplement o be taken as required to relieve symptoms

Interventions

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Hypromellose 0.15%

Tear supplement to be taken as required to relieve symptoms

Intervention Type OTHER

Hypromellose 0.4%

Tear supplement to be taken as required to relieve symptoms

Intervention Type OTHER

Carboxymethylcellulose

Tear supplement to be taken as required to relieve symptoms

Intervention Type OTHER

Liposomal Spray

Tear supplement o be taken as required to relieve symptoms

Intervention Type OTHER

Other Intervention Names

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Hypromellose is also sold as Isopto plain eye drops Hypromellose is also sold as Isopto plain eye drops Theratears Tears Again

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No