Dry EyeNCT01384851
Efficacy of the Chronic Application of Tear Formulations
A study testing Next Generation Emulsion, Refresh Dry Eye Therapy and Refresh Contacts in people with Dry Eye, run by Glasgow Caledonian University at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine the therapeutic effect of the chronic application of eye-drops on tear evaporation rate in dry eye and normal subjects exposed to a condition of environmental stress. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Next Generation Emulsion, Refresh Dry Eye Therapy and Refresh Contacts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2011to Nov 2011
- 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 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be between the ages of 18 and 79 years of age.
- Must understand and be able, willing and likely to fully comply with study procedures and restrictions.
Who cannot join
- Active ocular allergy
- Current contact lens wear
- Any topical ophthalmic drops within 1 week of initial screening visit.
- Started or changed the dose of chronic systemic medication known to affect tear production including, but not limited to antihistamines, antidepressants, diuretics, corticosteroids or immunomodulators within 30 days of initial screening visit.
- Systemic disease known to affect tear production or loss including, but not limited to thyroid eye disease, that has been diagnosed or has not been stable within 30 days initial of screening visit.
- Known hypersensitivity to any of the agents used in testing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Efficacy of the Chronic Application of Tear Formulations for Dry Eye and Normal Subjects Under Conditions of Environmental Stress
The purpose of this study is to determine the therapeutic effect of the chronic application of eye-drops on tear evaporation rate in dry eye and normal subjects exposed to a condition of environmental stress. The effect will be studied in terms of changes in tear physiology and the inflammatory biomarkers on the ocular surface.
Read the detailed description
Environmentally induced dry eye is a condition which occurs in otherwise asymptomatic individuals in certain situations, for example with the use of computers, in overheated or air conditioned workplaces and in conditions of low humidity. The most common ocular complaints associated with these environments are burning, dryness, stinging, and grittiness. Although the exact cause of these symptoms is unknown, it is thought that increased tear evaporation rate due to low humidity plays a vital role. The changes in tear film physiology, which occurs in these environments, have traditionally been dealt with by the use of eye drops (particularly the highly viscous variety), which have been shown to be an effective therapeutic option in the treatment of environmental dry eye disease. Previous studies of the use of eye-drops of various formulations has shown improvements in tear physiology in mild to moderate dry eye patients with their use in both acute and chronic application protocols. In this study, an attempt was made to relate the effects on tear physiology induced by variations in environmental conditions to the beneficial effect produced by the use of eye-drops.
- Conditions
- Dry Eye
- Being tested
- Next Generation Emulsion, Refresh Dry Eye Therapy, Refresh Contacts
- 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.
Next Generation EmulsionDrug
One drop both eyes 4 times daily for two weeks
Refresh Dry Eye TherapyDrug
One drop both eyes four times daily for two weeks
Refresh ContactsDrug
One drop both eyes four times daily for two weeks
| Study group | Role | What they receive |
|---|---|---|
| Next Generation Emulsion | Experimental | Next Generation Emulsion Multi-Dose Eye Drop (9963X) is a sterile, buffered, aqueous and emulsion topical ophthalmic product formulated for the relief of ocular surface irritation and symptoms of dryness. The Next Generation Emulsion 9963X formulation is an oil-in-water aqueous emulsion intended to replenish deficient aqueous and lipid components and stabilising the tear film. Receives: Drug: Next Generation Emulsion |
| Refresh Dry Eye Therapy | Active comparator | A preserved multi-dose formulation for use in treating dry eye symptomatology. The key ingredients are Castor oil, Polysorbate 80, Carbomer 1342 and Glycerin. Refresh Dry Eye Therapy® Lubricant Eye Drops contains emulsified castor oil, which enhances the natural oily superficial tear layer on the ocular surface. By stabilizing and supplementing the lipid layer, castor oil may retard evaporation of surface moisture. Receives: Drug: Refresh Dry Eye Therapy |
| Refresh Contacts | Active comparator | Solution contains carboxymethylcellulose sodium (carmellose), sodium chloride, boric acid, sodium borate, potassium chloride, calcium chloride, magnesium chloride, Purite®, sodium hydroxide, and purified water. This product is registered as a CE Mark medical device. Refresh Contacts Comfort drops providing soothing relief from tired, dry eyes. Although intended for contact lens wearers, the primary indication is for relief of dry eyes as is being studied in this investigation. Receives: Drug: Refresh Contacts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear Film Evaporation
Tear film evaporation will be determined with a 'Servo-Med EP-Evaporimeter'. This measures the relative humidity and temperature at two sensors separated by a known distance, above the evaporative surface. The ocular surface evaporation will be calculated from measurements of fluid loss with the eyes open and closed while the subject sits with the eye covered by a modified goggle.
Measured: Each subject will be followed for the duration of the study, an expected average of 8-9 weeks
Secondary outcomes (4)
Interferometry
The structure and quality of the tear film will be assessed by observing the interference fringes of the lipid layer. Interferometry facilitated with a miniature slow motion video will be used. The grading system developed previously in our laboratory will be utilised to grade the tear film distribution. This grading system classifies the tear film structure on the basis of the distribution of tears after a blink. Measurements are made while the subject sits quietly and looks into the lens of the device.
Measured: Each subject will be followed for the duration of the study, an expected average of 8-9 weeks
Tear Film Osmolarity
Tear film osmolarity was measured using an 'OcuSense TearLab Osmometer'. This employs a single use, disposable test card mounted to a collection pen, to obtain a small sample of tear fluid by passive capillary action from the inferior-temporal tear meniscus. The measurement of the electrical impedance is carried out within the pen. The pen is then docked into the reader, which calculates and displays the osmolarity result.
Measured: Each subject will be followed for the duration of the study, an expected average of 8-9 weeks
Non-invasive tear break up time
The 'HIR-CAL Grid' system based on a modified Bausch and Lomb keratometer will be used. The 'HIR-CAL Grid'will be focused on the pre-corneal tear film and the time before first distortion of the grid image will be recorded. This will indicate the non-invasive tear break up time. Three measurements will be taken while the subject is instructed to blink and then to hold the eye open while the examiner watches the reflection from the tear film, and the mean calculated.
Measured: Each subject will be followed for the duration of the study, an expected average of 8-9 weeks
Tear sampling and bio-marker analysis
Approximately 1 μl of tears will be collected from the subject's eye using a sterile micropipette.
It will then be diluted in cytokine assay buffer and simultaneously analysed for biomarkers of ocular surface disease (cytokines) using the Luminex Beadlyte assay system. The bio-markers to be studied are included in the Human high sensitivity cytokine/chemokine kit (Millipore). These markers are associated with pro-inflammatory activation and have been previously studied in dry eye and other inflammatory conditions.
Measured: Each subject will be followed for the duration of the study, an expected average of 8-9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionNov 2011 (estimated)
- Study completionNov 2011 (estimated)
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glasgow Caledonian University
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Investigators
- Alan Tomlinson, DSc PhD, Principal investigator, Glasgow Caledonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384851
- Sponsor's protocol ID
- AG9965-004
- Status last verified
- Feb 2011
- First submitted
- 23 Jun 2011
- Last updated
- 1 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Efficacy of the Chronic Application of Tear Formulations for Dry Eye and Normal Subjects Under Conditions of Environmental Stress
- ClinicalTrials.gov ID
- NCT01384851
- Acronym / sponsor ID
- AG9965-004
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Glasgow Caledonian UniversityUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Jul 2011
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 29 Jun 2011 (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.
The purpose of this study is to determine the therapeutic effect of the chronic application of eye-drops on tear evaporation rate in dry eye and normal subjects exposed to a condition of environmental stress. The effect will be studied in terms of changes in tear physiology and the inflammatory biomarkers on the ocular surface.
Detailed description
Environmentally induced dry eye is a condition which occurs in otherwise asymptomatic individuals in certain situations, for example with the use of computers, in overheated or air conditioned workplaces and in conditions of low humidity. The most common ocular complaints associated with these environments are burning, dryness, stinging, and grittiness. Although the exact cause of these symptoms is unknown, it is thought that increased tear evaporation rate due to low humidity plays a vital role. The changes in tear film physiology, which occurs in these environments, have traditionally been dealt with by the use of eye drops (particularly the highly viscous variety), which have been shown to be an effective therapeutic option in the treatment of environmental dry eye disease. Previous studies of the use of eye-drops of various formulations has shown improvements in tear physiology in mild to moderate dry eye patients with their use in both acute and chronic application protocols. In this study, an attempt was made to relate the effects on tear physiology induced by variations in environmental conditions to the beneficial effect produced by the use of eye-drops.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Next Generation Emulsion | Experimental | Drug: Next Generation EmulsionNext Generation Emulsion Multi-Dose Eye Drop (9963X) is a sterile, buffered, aqueous and emulsion topical ophthalmic product formulated for the relief of ocular surface irritation and symptoms of dryness. The Next Generation Emulsion 9963X formulation is an oil-in-water aqueous emulsion intended to replenish deficient aqueous and lipid components and stabilising the tear film. |
| Refresh Dry Eye Therapy | Active comparator | Drug: Refresh Dry Eye TherapyA preserved multi-dose formulation for use in treating dry eye symptomatology. The key ingredients are Castor oil, Polysorbate 80, Carbomer 1342 and Glycerin. Refresh Dry Eye Therapy® Lubricant Eye Drops contains emulsified castor oil, which enhances the natural oily superficial tear layer on the ocular surface. By stabilizing and supplementing the lipid layer, castor oil may retard evaporation of surface moisture. |
| Refresh Contacts | Active comparator | Drug: Refresh ContactsSolution contains carboxymethylcellulose sodium (carmellose), sodium chloride, boric acid, sodium borate, potassium chloride, calcium chloride, magnesium chloride, Purite®, sodium hydroxide, and purified water. This product is registered as a CE Mark medical device. Refresh Contacts Comfort drops providing soothing relief from tired, dry eyes. Although intended for contact lens wearers, the primary indication is for relief of dry eyes as is being studied in this investigation. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Be between the ages of 18 and 79 years of age.
- Must understand and be able, willing and likely to fully comply with study procedures and restrictions.
Key exclusion criteria (6 listed)
- Active ocular allergy
- Current contact lens wear
- Any topical ophthalmic drops within 1 week of initial screening visit.
- Started or changed the dose of chronic systemic medication known to affect tear production including, but not limited to antihistamines, antidepressants, diuretics, corticosteroids or immunomodulators within 30 days of initial screening visit.
- Systemic disease known to affect tear production or loss including, but not limited to thyroid eye disease, that has been diagnosed or has not been stable within 30 days initial of screening visit.
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 |
|---|---|---|
| Next Generation EmulsionOne drop both eyes 4 times daily for two weeks | Drug | Next Generation Emulsion |
| Refresh Dry Eye TherapyOne drop both eyes four times daily for two weeks | Drug | Refresh Dry Eye Therapy |
| Refresh ContactsOne drop both eyes four times daily for two weeks | Drug | Refresh Contacts |
Primary outcome
Tear Film Evaporation
Time frame: Each subject will be followed for the duration of the study, an expected average of 8-9 weeks
Tear film evaporation will be determined with a 'Servo-Med EP-Evaporimeter'. This measures the relative humidity and temperature at two sensors separated by a known distance, above the evaporative surface. The ocular surface evaporation will be calculated from measurements of fluid loss with the eyes open and closed while the subject sits with the eye covered by a modified goggle.
4 secondary outcomes
Interferometry
Time frame: Each subject will be followed for the duration of the study, an expected average of 8-9 weeks
Tear Film Osmolarity
Time frame: Each subject will be followed for the duration of the study, an expected average of 8-9 weeks
Non-invasive tear break up time
Time frame: Each subject will be followed for the duration of the study, an expected average of 8-9 weeks
Tear sampling and bio-marker analysis
Time frame: Each subject will be followed for the duration of the study, an expected average of 8-9 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2011.
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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.
Alan Tomlinson, DSc PhD principal investigator
Glasgow Caledonian 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 Next Generation Emulsion, Refresh Dry Eye Therapy and Refresh Contacts in people with Dry Eye, run by Glasgow Caledonian 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 1 Jul 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alan Tomlinson, DSc PhD (0044 141 331 ext. 3380, A.Tomlinson@gcu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tear Film Evaporation (time frame: Each subject will be followed for the duration of the study, an expected average of 8-9 weeks). 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 1 Jul 2011.