Dry Eye Treatment With Artificial Tears

Dry Eye Clinical Trial

Official title:

Dry Eye Treatment With Artificial Tears

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02420834
• Other study ID #: DOptomEssa
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: January 2019

Study information

• Verified date: January 2019
• Source: Aston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Other:
• Hypromellose 0.15%
Tear supplement to be taken as required to relieve symptoms
• Hypromellose 0.4%
Tear supplement to be taken as required to relieve symptoms
• Carboxymethylcellulose
Tear supplement to be taken as required to relieve symptoms
• Liposomal Spray
Tear supplement o be taken as required to relieve symptoms

Locations

Country	Name	City	State
United Kingdom	Specsavers	Thornton	Cleveleys

Sponsors (1)

Lead Sponsor	Collaborator
Aston University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms	Short questionnaire (Ocular Surface Disease Index)	4 months
Secondary	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	4 months
Secondary	Tear meniscus height	Tear meniscus height will be assessed in millimetres by comparing to the slit height adjustment of a slit lamp biomicroscope.	4 months
Secondary	lid parallel conjunctival folds	Lid parallel conjunctival folds will counted as observed with a slit lamp biomicroscope and timed/graded	4 months
Secondary	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	4 months
Secondary	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	4 months