Dry Eye Treatment With Artificial Tears

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Other: Hypromellose 0.15%; Other: Hypromellose 0.4%; Other: Carboxymethylcellulose; Other: Liposomal Spray

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cleveleys
    • Thornton, Cleveleys, United Kingdom, FY5 1AJ
      • Specsavers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tear Supplement Hypromellose 0.15%; Preservative free Hypromellose Eye Drops BP 0.15% applied as required for 1 month	Other: Hypromellose 0.15%; Tear supplement to be taken as required to relieve symptoms; Other Names: Hypromellose is also sold as Isopto plain eye drops
Experimental: Tear Supplement Hypromellose 0.4%; Preservative free Hypromellose Eye Drops BP 0.4% applied as required for 1 month	Other: Hypromellose 0.4%; Tear supplement to be taken as required to relieve symptoms; Other Names: Hypromellose is also sold as Isopto plain eye drops
Experimental: Tear Supplement Carboxymethylcellulose; Tear Supplement 3: Preservative free 0.25% Carboxymethylcellulose, electrolyte balanced (Theratears) applied as required for 1 month	Other: Carboxymethylcellulose; Tear supplement to be taken as required to relieve symptoms; Other Names: Theratears
Experimental: Tear Supplement Liposomal spray; Preservative free Phospholipid liposomal spray (Tears Again) applied as required for 1 month	Other: Liposomal Spray; Tear supplement o be taken as required to relieve symptoms; Other Names: Tears Again

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms	Short questionnaire (Ocular Surface Disease Index)	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
lid parallel conjunctival folds	Lid parallel conjunctival folds will counted as observed with a slit lamp biomicroscope and timed/graded	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	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	4 months

Collaborators and Investigators

• Sponsor: Aston University
• Investigators: Principal Investigator: James S Wolffsohn, BSc PhD, Aston University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: April 10, 2015
• First Submitted That Met QC Criteria: April 15, 2015
• First Posted (Estimate): April 20, 2015

Study Record Updates

• Last Update Posted (Actual): January 10, 2019
• Last Update Submitted That Met QC Criteria: January 9, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Gastrointestinal Agents; Pharmaceutical Solutions; Laxatives; Ophthalmic Solutions; Carboxymethylcellulose Sodium
• Other Study ID Numbers: DOptomEssa