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Dry Eye Treatment With Artificial Tears

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ClinicalTrials.gov Identifier: NCT02420834
Recruitment Status : Completed
First Posted : April 20, 2015
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Aston University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Dry Eye Other: Hypromellose 0.15% Other: Hypromellose 0.4% Other: Carboxymethylcellulose Other: Liposomal Spray Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dry Eye Treatment With Artificial Tears
Actual Study Start Date : April 2015
Actual Primary Completion Date : January 2019
Actual Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arms and Interventions
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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 Name: 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 Name: 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 Name: 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 Name: Tears Again


Outcome Measures
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Primary Outcome Measures :
  1. Symptoms [ Time Frame: 4 months ]
    Short questionnaire (Ocular Surface Disease Index)


Secondary Outcome Measures :
  1. Non-invasive break-up time [ Time Frame: 4 months ]
    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

  2. Tear meniscus height [ Time Frame: 4 months ]
    Tear meniscus height will be assessed in millimetres by comparing to the slit height adjustment of a slit lamp biomicroscope.

  3. lid parallel conjunctival folds [ Time Frame: 4 months ]
    Lid parallel conjunctival folds will counted as observed with a slit lamp biomicroscope and timed/graded

  4. Ocular Surface Staining [ Time Frame: 4 months ]
    Ocular surface staining with fluorescein and lissamine green dyes will be observed with a slitlamp biomicroscope and graded using the Efron grading scale

  5. Phenol Red Test [ Time Frame: 4 months ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02420834


Locations
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United Kingdom
Specsavers
Thornton, Cleveleys, United Kingdom, FY5 1AJ
Sponsors and Collaborators
Aston University
Investigators
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Principal Investigator: James S Wolffsohn, BSc PhD Aston University
More Information
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Responsible Party: Aston University
ClinicalTrials.gov Identifier: NCT02420834    
Other Study ID Numbers: DOptomEssa
First Posted: April 20, 2015    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
 Keratitis
Corneal Diseases
Carboxymethylcellulose Sodium
Ophthalmic Solutions
Pharmaceutical Solutions
Laxatives
Gastrointestinal Agents