Dry EyeNCT02417116
Tear Osmolarity Clinical Utility in Dry Eye Disease
A study testing Tear supplement, Tear supplement 2 and Omega 3 nutrition supplement in people with Dry Eye, run by Aston University at 6 sites in United Kingdom.
Trial summary
Millions of people suffer from dry eye disease, causing symptoms such as redness, burning, feeling of sand or grit in the eye and light sensitivity. Dry eye disease occurs when your eyes do not produce enough tears or produce poor quality tears. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Tear supplement, Tear supplement 2 and Omega 3 nutrition supplement
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- Jun 2015to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dry Eye Symptoms SPEED >8
Who cannot join
- Unable to participate in 90 days therapy
- Allergic to therapy
- On medication known to affect ocular surface / tear film
- Had ocular trauma, infection or surgery
- Diagnosed with a medical condition known to affect ocular surface / tear film
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
Black & Lizars Optometrists
Ayr, KA7 1UL
Robert Frith Opticians
Blandford Forum, Dorset, DT11 8AR
Robert Frith Opticians
Gillingham, Dorset, SP8 4AA
Black & Lizars Optometrists
Glasgow, G46 6JB
Robert Frith Opticians
Shaftesbury, Dorest, SP7 8AR
Robert Frith Opticians
Twickenham, Middlesex, TW1 4BW
About this study
Millions of people suffer from dry eye disease, causing symptoms such as redness, burning, feeling of sand or grit in the eye and light sensitivity. Dry eye disease occurs when your eyes do not produce enough tears or produce poor quality tears. This can happen for a number of reasons, including aging, hormonal changes in women and side effects of diseases or medications.
It is now possible to objectively measure the degree of dry eye disease by collecting a tiny sample of tears from the corner of the eye and then measuring the amount of salt in the tears (termed osmolarity). We aim to establish the overall levels of raised and normal tear osmolarity in people presenting to the eye clinic with complaints of dry eye, and relate this to other factors such as symptoms, topical and nutritional medication and dry eye treatment.
Read the detailed description
This study will investigate the efficacy of two treatment non-pharmaceutical therapies (tear drop alone, tear drop combined with omega 3 nutritional supplement and warm compresses) for dry eye reporting patients against a control (saline) over a 3 month period. A relatively new clinical measure (osmolarity) will be performed alongside traditional tear film volume, tear film stability, gland integrity and ocular surface damage measures to determine how this influences symptomatic complaints.
- Conditions
- Dry Eye
- Being tested
- Tear supplement, Tear supplement 2, Omega 3 nutrition supplement, Eye bag, Saline
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tear supplementOther
Also called Hypermellose 0.3% eye drop
Application as required to improve comfort
Tear supplement 2Other
Also called Hylo-Forte 0.2% Sodium Hyaluronate eye drop
Application as required to improve comfort
Omega 3 nutrition supplementDietary supplement
Also called Scope Ophthalmics Omega Eye
Taken each day
Eye bagDevice
Also called TranquilEyes Moist Heat Lid
Applied following microwave heating to closed eyelids for 5 minutes each day
SalineOther
Also called Minim sodium chloride 0.9% unpreserved
Application as required to improve comfort
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Minims Saline (Preservative Free) lubricant eye drops - daily for 90 days Receives: Other: Saline |
| Hypromellose - standard treatment | Active comparator | Tear Supplement: Hypromellose 0.3% eye drops - daily for 90 days Receives: Other: Tear supplement |
| Combination treatment | Active comparator | Tear Supplement 2: Hylo-Forte 0.2% Sodium Hyaluronate eye drops, Omega 3 nutrition supplement: Omega-3 tablets, Eye bag: TranquilEyes Moist Heat Lid Compresses - Daily for 90 days; Receives: Other: Tear supplement 2; Dietary Supplement: Omega 3 nutrition supplement; Device: Eye bag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osmolarity change
Salt balance in tears measured with the Tearlab
Measured: 3 months
Secondary outcomes (5)
Tear break-up time change
Tear stability following a blink
Measured: 3 months
Corneal staining change
Fluorescein dye applied to the ocular surface and observed with blue light and a yellow filter to observe staining fluorescence
Measured: 3 months
Meibomian gland change
Grading of meibomian glands using Oxford scale
Measured: 3 months
Tear Meniscus Height
Height of tear meniscus along the lower lid margin observed through a slit-lamp microscope
Measured: 3 months
SPEED Questionnaire change
Dry eye symptomology questionnaire
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aston University
- Sponsor type
- University, hospital or other
- Collaborators
- TearLab Corporation
- Responsible party
- Sponsor
- Investigators
- James Wolffsohn, BSc MBA PhD, Principal investigator, Aston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417116
- Sponsor's protocol ID
- TP00128
- Status last verified
- Jan 2019
- First submitted
- 10 Apr 2015
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tear Osmolarity Clinical Utility in Dry Eye Disease
- ClinicalTrials.gov ID
- NCT02417116
- Acronym / sponsor ID
- TP00128
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Aston UniversityUniversity, hospital or other
- Collaborators
- TearLab Corporation
- Study start
- Jun 2015 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 15 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Millions of people suffer from dry eye disease, causing symptoms such as redness, burning, feeling of sand or grit in the eye and light sensitivity. Dry eye disease occurs when your eyes do not produce enough tears or produce poor quality tears. This can happen for a number of reasons, including aging, hormonal changes in women and side effects of diseases or medications.
It is now possible to objectively measure the degree of dry eye disease by collecting a tiny sample of tears from the corner of the eye and then measuring the amount of salt in the tears (termed osmolarity). We aim to establish the overall levels of raised and normal tear osmolarity in people presenting to the eye clinic with complaints of dry eye, and relate this to other factors such as symptoms, topical and nutritional medication and dry eye treatment.
Detailed description
This study will investigate the efficacy of two treatment non-pharmaceutical therapies (tear drop alone, tear drop combined with omega 3 nutritional supplement and warm compresses) for dry eye reporting patients against a control (saline) over a 3 month period. A relatively new clinical measure (osmolarity) will be performed alongside traditional tear film volume, tear film stability, gland integrity and ocular surface damage measures to determine how this influences symptomatic complaints.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: SalineMinims Saline (Preservative Free) lubricant eye drops - daily for 90 days |
| Hypromellose - standard treatment | Active comparator | Other: Tear supplementTear Supplement: Hypromellose 0.3% eye drops - daily for 90 days |
| Combination treatment | Active comparator | Other: Tear supplement 2, Dietary Supplement: Omega 3 nutrition supplement, Device: Eye bagTear Supplement 2: Hylo-Forte 0.2% Sodium Hyaluronate eye drops, Omega 3 nutrition supplement: Omega-3 tablets, Eye bag: TranquilEyes Moist Heat Lid Compresses - Daily for 90 days; |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Dry Eye Symptoms SPEED >8
Key exclusion criteria (5 listed)
- Unable to participate in 90 days therapy
- Allergic to therapy
- On medication known to affect ocular surface / tear film
- Had ocular trauma, infection or surgery
- Diagnosed with a medical condition known to affect ocular surface / tear film
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tear supplementAlso: Hypermellose 0.3% eye dropApplication as required to improve comfort | Other | Hypromellose - standard treatment |
| Tear supplement 2Also: Hylo-Forte 0.2% Sodium Hyaluronate eye dropApplication as required to improve comfort | Other | Combination treatment |
| Omega 3 nutrition supplementAlso: Scope Ophthalmics Omega EyeTaken each day | Dietary supplement | Combination treatment |
| Eye bagAlso: TranquilEyes Moist Heat LidApplied following microwave heating to closed eyelids for 5 minutes each day | Device | Combination treatment |
| SalineAlso: Minim sodium chloride 0.9% unpreservedApplication as required to improve comfort | Other | Control |
Primary outcome
Osmolarity change
Time frame: 3 months
Salt balance in tears measured with the Tearlab
5 secondary outcomes
Tear break-up time change
Time frame: 3 months
Corneal staining change
Time frame: 3 months
Meibomian gland change
Time frame: 3 months
Tear Meniscus Height
Time frame: 3 months
SPEED Questionnaire change
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Wolffsohn, BSc MBA PhD principal investigator
Aston University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tear supplement, Tear supplement 2 and Omega 3 nutrition supplement in people with Dry Eye, run by Aston University at 6 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Osmolarity change (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.