Dry Eye Treatment With Artificial Tears
Primary Purpose
Dry Eye
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Hypromellose 0.15%
Hypromellose 0.4%
Carboxymethylcellulose
Liposomal Spray
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility 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.
Sites / Locations
- Specsavers
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Tear Supplement Hypromellose 0.15%
Tear Supplement Hypromellose 0.4%
Tear Supplement Carboxymethylcellulose
Tear Supplement Liposomal spray
Arm Description
Preservative free Hypromellose Eye Drops BP 0.15% applied as required for 1 month
Preservative free Hypromellose Eye Drops BP 0.4% applied as required for 1 month
Tear Supplement 3: Preservative free 0.25% Carboxymethylcellulose, electrolyte balanced (Theratears) applied as required for 1 month
Preservative free Phospholipid liposomal spray (Tears Again) applied as required for 1 month
Outcomes
Primary Outcome Measures
Symptoms
Short questionnaire (Ocular Surface Disease Index)
Secondary Outcome Measures
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
Tear meniscus height
Tear meniscus height will be assessed in millimetres by comparing to the slit height adjustment of a slit lamp biomicroscope.
lid parallel conjunctival folds
Lid parallel conjunctival folds will counted as observed with a slit lamp biomicroscope and timed/graded
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02420834
Brief Title
Dry Eye Treatment With Artificial Tears
Official Title
Dry Eye Treatment With Artificial Tears
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aston University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tear Supplement Hypromellose 0.15%
Arm Type
Experimental
Arm Description
Preservative free Hypromellose Eye Drops BP 0.15% applied as required for 1 month
Arm Title
Tear Supplement Hypromellose 0.4%
Arm Type
Experimental
Arm Description
Preservative free Hypromellose Eye Drops BP 0.4% applied as required for 1 month
Arm Title
Tear Supplement Carboxymethylcellulose
Arm Type
Experimental
Arm Description
Tear Supplement 3: Preservative free 0.25% Carboxymethylcellulose, electrolyte balanced (Theratears) applied as required for 1 month
Arm Title
Tear Supplement Liposomal spray
Arm Type
Experimental
Arm Description
Preservative free Phospholipid liposomal spray (Tears Again) applied as required for 1 month
Intervention Type
Other
Intervention Name(s)
Hypromellose 0.15%
Other Intervention Name(s)
Hypromellose is also sold as Isopto plain eye drops
Intervention Description
Tear supplement to be taken as required to relieve symptoms
Intervention Type
Other
Intervention Name(s)
Hypromellose 0.4%
Other Intervention Name(s)
Hypromellose is also sold as Isopto plain eye drops
Intervention Description
Tear supplement to be taken as required to relieve symptoms
Intervention Type
Other
Intervention Name(s)
Carboxymethylcellulose
Other Intervention Name(s)
Theratears
Intervention Description
Tear supplement to be taken as required to relieve symptoms
Intervention Type
Other
Intervention Name(s)
Liposomal Spray
Other Intervention Name(s)
Tears Again
Intervention Description
Tear supplement o be taken as required to relieve symptoms
Primary Outcome Measure Information:
Title
Symptoms
Description
Short questionnaire (Ocular Surface Disease Index)
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Non-invasive break-up time
Description
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
Title
Tear meniscus height
Description
Tear meniscus height will be assessed in millimetres by comparing to the slit height adjustment of a slit lamp biomicroscope.
Time Frame
4 months
Title
lid parallel conjunctival folds
Description
Lid parallel conjunctival folds will counted as observed with a slit lamp biomicroscope and timed/graded
Time Frame
4 months
Title
Ocular Surface Staining
Description
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
Title
Phenol Red Test
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James S Wolffsohn, BSc PhD
Organizational Affiliation
Aston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Specsavers
City
Thornton
State/Province
Cleveleys
ZIP/Postal Code
FY5 1AJ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Dry Eye Treatment With Artificial Tears
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