An interventional study of Hypromellose 0.15% and Hypromellose 0.4% in Dry Eye, sponsored by Aston University. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-10.
Sponsored by Aston University · Not applicable, Interventional, and Treatment
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.
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.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 192 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Aston University is the lead sponsor of 27 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Preservative free Hypromellose Eye Drops BP 0.15% applied as required for 1 month
Other: Hypromellose 0.15%
Preservative free Hypromellose Eye Drops BP 0.4% applied as required for 1 month
Other: Hypromellose 0.4%
Tear Supplement 3: Preservative free 0.25% Carboxymethylcellulose, electrolyte balanced (Theratears) applied as required for 1 month
Other: Carboxymethylcellulose
Preservative free Phospholipid liposomal spray (Tears Again) applied as required for 1 month
Other: Liposomal Spray
Tear supplement to be taken as required to relieve symptoms
Also known as: Hypromellose is also sold as Isopto plain eye drops
Tear supplement to be taken as required to relieve symptoms
Also known as: Hypromellose is also sold as Isopto plain eye drops
Tear supplement to be taken as required to relieve symptoms
Also known as: Theratears
Tear supplement o be taken as required to relieve symptoms
Also known as: Tears Again
Symptoms
Short questionnaire (Ocular Surface Disease Index)
Time frame: 4 months
Non-invasive break-up time
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
Time frame: 4 months
Tear meniscus height
Tear meniscus height will be assessed in millimetres by comparing to the slit height adjustment of a slit lamp biomicroscope.
Time frame: 4 months
lid parallel conjunctival folds
Lid parallel conjunctival folds will counted as observed with a slit lamp biomicroscope and timed/graded
Time frame: 4 months
Ocular Surface Staining
Ocular surface staining with fluorescein and lissamine green dyes will be observed with a slitlamp biomicroscope and graded using the Efron grading scale
Time frame: 4 months
Phenol Red Test
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
Time frame: 4 months
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Aston University