Dry Eye Syndrome
Conditions
Keywords
Treatment, Dry Eye
Brief 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.
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.
Interventions
DRUGCyclosporin A Restasis®
DRUGBlink tears
blink tears to be used twice a day
DRUGSystane
systane to be used twice a day
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject must have dry eye. 2. Age: 18 years and older. 3. Males or females 4. Up to grade 3 conjunctival staining. 5. Score of no more than 4 on the Subjective Evaluation of Symptoms of Dryness (SESOD) at screening. 6. Currently using Restasis to treat dry eye syndrome (at least for 3 months prior to enrollment). 7. Willing and able to comply with scheduled visits and other study procedures.
Exclusion criteria
1. Prior unsuccessful use of topical cyclosporine (defined as patients taking it at least 3 months without improvement. 2. Known contraindications to any study medication or ingredients. 3. Planned use of contact lenses (unless discontinued use more than 30 days prior to randomization. 4. Contact lens use during the active treatment portion of the trial. 5. Active ocular allergies. 6. Ocular surgery within the past 3 months. 7. Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis. 8. Active ocular diseases or uncontrolled systemic disease (blepharitis patients that are actively being treated or disease that is uncontrollable. 9. Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control. 10. Participation in (or current participation) any investigational drug or device trial. 11. Conjuctival staining grade 4.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Schirmer's Scores | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Blink Tears | 11 |
| Systane | 9 |
| Total | 20 |
Baseline characteristics
| Characteristic | Blink Tears | Total | Systane |
|---|---|---|---|
| Age, Continuous | 66.3 years STANDARD_DEVIATION 9.7 | 66.8 years STANDARD_DEVIATION 8.8 | 67.4 years STANDARD_DEVIATION 7.82 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 20 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 20 Participants | 9 Participants |
| Region of Enrollment United States | 11 Participants | 20 Participants | 9 Participants |
| Sex: Female, Male Female | 10 Participants | 19 Participants | 9 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 11 | 0 / 9 |
| serious Total, serious adverse events | 0 / 11 | 0 / 9 |
Outcome results
Primary
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).
Time frame: baseline to 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blink Tears | Change in Schirmer's Scores | -.30 score on a scale | Standard Error 2.82 |
| Systane | Change in Schirmer's Scores | -1.06 score on a scale | Standard Error 4.17 |