Dry Eye SyndromeNCT00565669
Evaluation of Blink Tears and Systane Concomitant With Restasis for the Treatment of Dry Eye Symptoms
A study testing Cyclosporin A Restasis®, Blink tears and Systane in people with Dry Eye Syndrome, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of Blink Tears and Systane used concomitantly with topical cyclosporine for the treatment of dry eye. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- Cyclosporin A Restasis®, Blink tears and Systane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Oct 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject must have dry eye.
- Age: 18 years and older.
- Males or females
- Up to grade 3 conjunctival staining.
- Score of no more than 4 on the Subjective Evaluation of Symptoms of Dryness (SESOD) at screening.
- Currently using Restasis to treat dry eye syndrome (at least for 3 months prior to enrollment).
- Willing and able to comply with scheduled visits and other study procedures.
Who cannot join
- Prior unsuccessful use of topical cyclosporine (defined as patients taking it at least 3 months without improvement.
- Known contraindications to any study medication or ingredients.
- Planned use of contact lenses (unless discontinued use more than 30 days prior to randomization.
- Contact lens use during the active treatment portion of the trial.
- Active ocular allergies.
- Ocular surgery within the past 3 months.
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- Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis.
- Active ocular diseases or uncontrolled systemic disease (blepharitis patients that are actively being treated or disease that is uncontrollable.
- Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control.
- Participation in (or current participation) any investigational drug or device trial.
- Conjuctival staining grade 4.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina, Storm Eye Institute
Charleston, South Carolina, 29425
About this study
The purpose of this study is to evaluate the efficacy of Blink Tears and Systane used concomitantly with topical cyclosporine for the treatment of dry eye.
Read the detailed description
Dry eye is a chronic condition that is believed to afflict more than 3 million patients in the United States.1 Symptoms of dry eye are very bothersome and impact quality of life, reduce work capacity, and may result in poorer psychological health. Also, symptoms of dry eye are associated with a decreased ability to perform activities that require visual attention such as reading and driving a car.2 Patients with dry eye complain most frequently of a scratchy or sandy (foreign body) sensation. Other common symptoms are itching, excessive mucus secretion, inability to produce tears, a burning sensation, photosensitivity, redness, pain, and difficulty in moving the lids. In most patients, the most remarkable feature of the eye examination is the grossly normal appearance of the eye.3 Chronic dry eye disease is associated with an inflammatory mechanism mediated by activated T-cell lymphocytes3 which affects the ocular surface and lacrimal gland.4 The damage caused by dry eye disease may be irreversible, and despite the availability of various tear substitutes, many patients with dry eye syndrome experience corneal injuries with a subsequent reduction in vision.5 Cyclosporin A (Restasis®, Allergan, Irvine, CA) has been shown to significantly reduce the number of activated T-lymphocytes within the conjunctiva6, thereby minimizing the inflammation causing dry eye. Topical cyclosporin A 0.05% ophthalmic emulsion (Restasis®, Allergan, Irvine, CA) increases tear production and improves the quality of naturally produced tears and is the first approved therapeutic agent for the treatment of chronic dry eye and the only treatment modality that addresses the underlying pathology.
In addition to topical therapy with cyclosporine, some patients continue to use artificial tears for occasional relief of residual symptoms. The choice of concomitant tear is important but little research has been published differentiating between the efficacy of these solutions when used concomitantly with topical cyclosporine.
- Conditions
- Dry Eye Syndrome
- Being tested
- Cyclosporin A Restasis®, Blink tears, Systane
- Keywords
- Treatment, Dry Eye
- 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.
Cyclosporin A Restasis®Drug
Blink tearsDrug
blink tears to be used twice a day
SystaneDrug
systane to be used twice a day
| Study group | Role | What they receive |
|---|---|---|
| Blink Tears | Experimental | Not described Receives: Drug: Cyclosporin A Restasis®; Drug: Blink tears |
| Systane | Experimental | Not described Receives: Drug: Cyclosporin A Restasis®; Drug: Systane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Schirmer's Scores
The Schirmer score is a score on a scale - minimum is 0 and the highest is 35 mm. Above 15 mm is normal and less than 5 is severe dry eyes. A positive score means there was an improvement, 0 will be no change from baseline and a negative one that there was a decreased in tears. This change was calculated by subtracting the baseline value from the 3 months value (3 mo Schirmer's - baseline Schirmer's = amount of change).
Measured: baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kerry D. Solomon, MD, Principal investigator, Medical University of South Carolina, Storm Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565669
- Sponsor's protocol ID
- SEI-07-003
- Status last verified
- Oct 2018
- First submitted
- 29 Nov 2007
- Last updated
- 7 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Blink Tears and Systane Concomitant With Restasis for the Treatment of Dry Eye Symptoms
- ClinicalTrials.gov ID
- NCT00565669
- Acronym / sponsor ID
- SEI-07-003
- Conditions
- Dry Eye Syndrome
- Keywords
- Treatment, Dry Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 30 Nov 2007 (estimated)
- Results
- Posted 7 Nov 2018
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 evaluate the efficacy of Blink Tears and Systane used concomitantly with topical cyclosporine for the treatment of dry eye.
Detailed description
Dry eye is a chronic condition that is believed to afflict more than 3 million patients in the United States.1 Symptoms of dry eye are very bothersome and impact quality of life, reduce work capacity, and may result in poorer psychological health. Also, symptoms of dry eye are associated with a decreased ability to perform activities that require visual attention such as reading and driving a car.2 Patients with dry eye complain most frequently of a scratchy or sandy (foreign body) sensation. Other common symptoms are itching, excessive mucus secretion, inability to produce tears, a burning sensation, photosensitivity, redness, pain, and difficulty in moving the lids. In most patients, the most remarkable feature of the eye examination is the grossly normal appearance of the eye.3 Chronic dry eye disease is associated with an inflammatory mechanism mediated by activated T-cell lymphocytes3 which affects the ocular surface and lacrimal gland.4 The damage caused by dry eye disease may be irreversible, and despite the availability of various tear substitutes, many patients with dry eye syndrome experience corneal injuries with a subsequent reduction in vision.5 Cyclosporin A (Restasis®, Allergan, Irvine, CA) has been shown to significantly reduce the number of activated T-lymphocytes within the conjunctiva6, thereby minimizing the inflammation causing dry eye. Topical cyclosporin A 0.05% ophthalmic emulsion (Restasis®, Allergan, Irvine, CA) increases tear production and improves the quality of naturally produced tears and is the first approved therapeutic agent for the treatment of chronic dry eye and the only treatment modality that addresses the underlying pathology.
In addition to topical therapy with cyclosporine, some patients continue to use artificial tears for occasional relief of residual symptoms. The choice of concomitant tear is important but little research has been published differentiating between the efficacy of these solutions when used concomitantly with topical cyclosporine.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blink Tears | Experimental | Drug: Cyclosporin A Restasis®, Drug: Blink tears |
| Systane | Experimental | Drug: Cyclosporin A Restasis®, Drug: Systane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject must have dry eye.
- Age: 18 years and older.
- Males or females
- Up to grade 3 conjunctival staining.
- Score of no more than 4 on the Subjective Evaluation of Symptoms of Dryness (SESOD) at screening.
Key exclusion criteria (11 listed)
- Prior unsuccessful use of topical cyclosporine (defined as patients taking it at least 3 months without improvement.
- Known contraindications to any study medication or ingredients.
- Planned use of contact lenses (unless discontinued use more than 30 days prior to randomization.
- Contact lens use during the active treatment portion of the trial.
- Active ocular allergies.
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 |
|---|---|---|
| Cyclosporin A Restasis® | Drug | Blink Tears, Systane |
| Blink tearsblink tears to be used twice a day | Drug | Blink Tears |
| Systanesystane to be used twice a day | Drug | Systane |
Primary outcome
Change in Schirmer's Scores
Time frame: baseline to 3 months
The Schirmer score is a score on a scale - minimum is 0 and the highest is 35 mm. Above 15 mm is normal and less than 5 is severe dry eyes. A positive score means there was an improvement, 0 will be no change from baseline and a negative one that there was a decreased in tears. This change was calculated by subtracting the baseline value from the 3 months value (3 mo Schirmer's - baseline Schirmer's = amount of change).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kerry D. Solomon, MD principal investigator
Medical University of South Carolina, Storm Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyclosporin A Restasis®, Blink tears and Systane in people with Dry Eye Syndrome, run by Medical University of South Carolina at 1 site in United States.
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 7 inclusion and 11 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 7 Nov 2018. 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 States. 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?
Yes. Results are posted in the registry (first posted 7 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Schirmer's Scores (time frame: baseline to 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 7 Nov 2018.