Overview

This trial is active, not recruiting.

Condition dry eye
Treatments hypromellose 0.15%, hypromellose 0.4%, carboxymethylcellulose, liposomal spray
Phase phase 4
Sponsor Aston University
Start date April 2015
End date August 2016
Trial size 50 participants
Trial identifier NCT02420834, DOptomEssa

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Preservative free Hypromellose Eye Drops BP 0.15% applied as required for 1 month
hypromellose 0.15% Hypromellose is also sold as Isopto plain eye drops
Tear supplement to be taken as required to relieve symptoms
(Experimental)
Preservative free Hypromellose Eye Drops BP 0.4% applied as required for 1 month
hypromellose 0.4% Hypromellose is also sold as Isopto plain eye drops
Tear supplement to be taken as required to relieve symptoms
(Experimental)
Tear Supplement 3: Preservative free 0.25% Carboxymethylcellulose, electrolyte balanced (Theratears) applied as required for 1 month
carboxymethylcellulose Theratears
Tear supplement to be taken as required to relieve symptoms
(Experimental)
Preservative free Phospholipid liposomal spray (Tears Again) applied as required for 1 month
liposomal spray Tears Again
Tear supplement o be taken as required to relieve symptoms

Primary Outcomes

Measure
Symptoms
time frame: 4 months

Secondary Outcomes

Measure
Non-invasive break-up time
time frame: 4 months
Tear meniscus height
time frame: 4 months
lid parallel conjunctival folds
time frame: 4 months
Ocular Surface Staining
time frame: 4 months
Phenol Red Test
time frame: 4 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Dry Eye Treatment With Artificial Tears
Principal investigator James S Wolffsohn, BSc PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Aston University.