Dry EyeNCT02420834
Dry Eye Treatment With Artificial Tears
A study testing Hypromellose 0.15%, Hypromellose 0.4% and Carboxymethylcellulose in people with Dry Eye, run by Aston University at 1 site in United Kingdom.
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. 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?
- Hypromellose 0.15%, Hypromellose 0.4% and Carboxymethylcellulose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 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
- subjective symptoms indicative of dry eye
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Dry Eye
- Being tested
- Hypromellose 0.15%, Hypromellose 0.4%, Carboxymethylcellulose, Liposomal Spray
- 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.
Hypromellose 0.15%Other
Also called Hypromellose is also sold as Isopto plain eye drops
Tear supplement to be taken as required to relieve symptoms
Hypromellose 0.4%Other
Also called Hypromellose is also sold as Isopto plain eye drops
Tear supplement to be taken as required to relieve symptoms
CarboxymethylcelluloseOther
Also called Theratears
Tear supplement to be taken as required to relieve symptoms
Liposomal SprayOther
Also called Tears Again
Tear supplement o be taken as required to relieve symptoms
| Study group | Role | What they receive |
|---|---|---|
| Tear Supplement Hypromellose 0.15% | Experimental | Preservative free Hypromellose Eye Drops BP 0.15% applied as required for 1 month Receives: Other: Hypromellose 0.15% |
| Tear Supplement Hypromellose 0.4% | Experimental | Preservative free Hypromellose Eye Drops BP 0.4% applied as required for 1 month Receives: Other: Hypromellose 0.4% |
| Tear Supplement Carboxymethylcellulose | Experimental | Tear Supplement 3: Preservative free 0.25% Carboxymethylcellulose, electrolyte balanced (Theratears) applied as required for 1 month Receives: Other: Carboxymethylcellulose |
| Tear Supplement Liposomal spray | Experimental | Preservative free Phospholipid liposomal spray (Tears Again) applied as required for 1 month Receives: Other: Liposomal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms
Short questionnaire (Ocular Surface Disease Index)
Measured: 4 months
Secondary outcomes (5)
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
Measured: 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.
Measured: 4 months
lid parallel conjunctival folds
Lid parallel conjunctival folds will counted as observed with a slit lamp biomicroscope and timed/graded
Measured: 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
Measured: 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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study startApr 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James S Wolffsohn, BSc PhD, Principal investigator, Aston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02420834
- Sponsor's protocol ID
- DOptomEssa
- 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
- Dry Eye Treatment With Artificial Tears
- ClinicalTrials.gov ID
- NCT02420834
- Acronym / sponsor ID
- DOptomEssa
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Aston UniversityUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 20 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tear Supplement Hypromellose 0.15% | Experimental | Other: Hypromellose 0.15%Preservative free Hypromellose Eye Drops BP 0.15% applied as required for 1 month |
| Tear Supplement Hypromellose 0.4% | Experimental | Other: Hypromellose 0.4%Preservative free Hypromellose Eye Drops BP 0.4% applied as required for 1 month |
| Tear Supplement Carboxymethylcellulose | Experimental | Other: CarboxymethylcelluloseTear Supplement 3: Preservative free 0.25% Carboxymethylcellulose, electrolyte balanced (Theratears) applied as required for 1 month |
| Tear Supplement Liposomal spray | Experimental | Other: Liposomal SprayPreservative free Phospholipid liposomal spray (Tears Again) applied as required for 1 month |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- subjective symptoms indicative of dry eye
Key exclusion criteria (8 listed)
- Diabetes
- Sjögren's Syndrome
- recent ocular infection
- hay fever
- used any eye drops or ocular medications,
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 |
|---|---|---|
| Hypromellose 0.15%Also: Hypromellose is also sold as Isopto plain eye dropsTear supplement to be taken as required to relieve symptoms | Other | Tear Supplement Hypromellose 0.15% |
| Hypromellose 0.4%Also: Hypromellose is also sold as Isopto plain eye dropsTear supplement to be taken as required to relieve symptoms | Other | Tear Supplement Hypromellose 0.4% |
| CarboxymethylcelluloseAlso: TheratearsTear supplement to be taken as required to relieve symptoms | Other | Tear Supplement Carboxymethylcellulose |
| Liposomal SprayAlso: Tears AgainTear supplement o be taken as required to relieve symptoms | Other | Tear Supplement Liposomal spray |
Primary outcome
Symptoms
Time frame: 4 months
Short questionnaire (Ocular Surface Disease Index)
5 secondary outcomes
Non-invasive break-up time
Time frame: 4 months
Tear meniscus height
Time frame: 4 months
lid parallel conjunctival folds
Time frame: 4 months
Ocular Surface Staining
Time frame: 4 months
Phenol Red Test
Time frame: 4 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 S Wolffsohn, BSc PhD principal investigator
Aston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypromellose 0.15%, Hypromellose 0.4% and Carboxymethylcellulose in people with Dry Eye, run by Aston University at 1 site 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 8 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 1 site 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. 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?
Symptoms (time frame: 4 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.