Dry Eye Syndrome
Conditions
Keywords
functional vision, contrast sensitivity, aberrometry, reading ability
Brief summary
The purpose of this study is to investigate how the addition of a new emulsion artificial tear to the tear layer of dry eye and normal patients affects aberrometry, contrast sensitivity, and reading ability over time. Previous studies have indicated that daily use of artificial tears over a two week period decreases the short term affect of drop application on aberrometry and contrast sensitivity measurements. The present study will examine the effects of 4 weeks of artificial tear use to determine when the responses stabilize.
Detailed description
Dry eye patients experience symptoms such as; irritation, dryness, a scratchy sensation, and blur. These symptoms are the result of an insufficient tear layer. Blur can occur in dry eye patients because of an irregular tear film surface. Artificial tears are applied to the eye to treat a variety of eye conditions. These conditions typically are associated with dry eyes and include tear film deficiency due to ocular or systemic disease, lid resurfacing problems, and contact lens wear. The artificial tears are used to alleviate the dry eye symptoms. Dry eye is a frequently encountered ocular condition. Recent studies estimate that 7.8% of women and 4.8% of men over the age of 50 suffer from dry eye. The administration of an artificial tear to the eye can disrupt the tear layer and this disruption could then result in a change in contrast sensitivity for a few moments. Aberrometry is a technique that is able to monitor tear layer disruption and its results may correlate with contrast sensitivity changes. Tear layer disruption results in a decrease in the modulation transfer function (MTF) for the eye. Since the tear layer is the first refracting surface of the eye, its disruption can also result in a change in contrast sensitivity, visual acuity, and aberrometry. Previous work has demonstrated that higher order aberrations increase 1.44 fold after the tear film breaks up in normal subjects. Dry eye subjects demonstrate a significant increase in higher order aberrations (i.e., total S3+4+5, spherical-like S4, and coma-like S3+5) when compared to normal subjects. This has been interpreted to be the result of increased tear irregularities in the dry eye subjects. When an artificial tear (i.e., Vismed) was applied to the tear layer of dry eye subjects, the optical aberrations decreased. This previous study only examined the short term affect (less than 10 minutes) of a single administration of an artificial tear. In this study, we propose to examine the short and long term effects of a new emulsion on contrast sensitivity, optical aberrations, and reading ability after administration into the tear layer of normal and dry eye subjects.
Interventions
OTHEROptive, Soothe, New Emulsion
One week without artificial tear use followed by Optive use a minimum of 2 drops per day for 1 month. One week without artificial tear use followed by Soothe use a minimum of 2 drops per day for 1 month. One week without artificial tear use followed by the New Emulsion use a minimum of 2 drops per day for 1 month.
OTHERSoothe, New Emulsion, Optive
One week without artificial tear use followed by Soothe use a minimum of 2 drops per day for 1 month. One week without artificial tear use followed by New Emulsion use a minimum of 2 drops per day for 1 month. One week without artificial tear use followed by the Optive use a minimum of 2 drops per day for 1 month.
OTHERNew Emulsion, Optive, Soothe
One week without artificial tear use followed by New Emulsion use a minimum of 2 drops per day for 1 month. One week without artificial tear use followed by Optive use a minimum of 2 drops per day for 1 month. One week without artificial tear use followed by the Soothe use a minimum of 2 drops per day for 1 month.
Sponsors
Allergan
Southern California College of Optometry at Marshall B. Ketchum University
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* mild, moderate, or severe symptoms of dry eye
Exclusion criteria
* uncontrolled systemic disease * contact lens wear * participation in another clinical trial * best corrected visual acuity poorer than 20/25
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contrast Sensitivity | Baseline, 1 week, 2 weeks, 4 weeks | Change in contrast sensitivity with administration of the artificial tear. During a visit, contrast sensitivity is initially monitored for several minutes (i.e., pre-artificial tear application contrast sensitivity) and the artificial tear is then applied and the contrast sensitivity is continually measured for several more minutes (post-artificial tear application contrast sensitivity). The administration of the artificial tear decreases contrast sensitivity for approximately a minute. The data reported in the table is the change in contrast sensitivity from pre-artificial tear administration to the peak loss in contrast sensitivity after the artificial tear administration (negative values). This procedure is carried out before the subjects use artificial tears on a daily basis (i.e., baseline data) and for several weeks after using artificial tears on a daily basis (i.e., weeks 1, 2, and 4) to determine if there is an adaptation to the artificial tear. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from the patients and staff of the clinic. The recruitment period was from 10/1/2009 till 7/30/2010.
Pre-assignment details
The subjects were not allowed to use artificial tears for 1 week before the study started.
Participants by arm
| Arm | Count |
|---|---|
| Optive, Soothe, New Emulsion Drop order was Optive, then Soothe, then New Emulsion. | 7 |
| Soothe, New Emulsion, Optive Drop order was Soothe, then New Emulsion, then Optive. | 7 |
| New Emulsion, Optive, Soothe Drop order was New Emulsion, then Optive, then Soothe. | 6 |
| Total | 20 |
Baseline characteristics
| Characteristic | Total | Soothe, New Emulsion, Optive | Optive, Soothe, New Emulsion | New Emulsion, Optive, Soothe |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 7 Participants | 7 Participants | 6 Participants |
| Age, Continuous | 23.6 years STANDARD_DEVIATION 1.82 | 22.6 years STANDARD_DEVIATION 1.67 | 23.8 years STANDARD_DEVIATION 1.6 | 24.4 years STANDARD_DEVIATION 2.07 |
| Region of Enrollment United States | 20 participants | 7 participants | 7 participants | 6 participants |
| Sex: Female, Male Female | 17 Participants | 6 Participants | 7 Participants | 4 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
Contrast Sensitivity
Change in contrast sensitivity with administration of the artificial tear. During a visit, contrast sensitivity is initially monitored for several minutes (i.e., pre-artificial tear application contrast sensitivity) and the artificial tear is then applied and the contrast sensitivity is continually measured for several more minutes (post-artificial tear application contrast sensitivity). The administration of the artificial tear decreases contrast sensitivity for approximately a minute. The data reported in the table is the change in contrast sensitivity from pre-artificial tear administration to the peak loss in contrast sensitivity after the artificial tear administration (negative values). This procedure is carried out before the subjects use artificial tears on a daily basis (i.e., baseline data) and for several weeks after using artificial tears on a daily basis (i.e., weeks 1, 2, and 4) to determine if there is an adaptation to the artificial tear.
Time frame: Baseline, 1 week, 2 weeks, 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Optive Normal | Contrast Sensitivity | Week 2 | -0.186 arbitrary units | Standard Error 0.109 |
| Optive Normal | Contrast Sensitivity | Baseline | -0.375 arbitrary units | Standard Error 0.139 |
| Optive Normal | Contrast Sensitivity | Week 4 | -0.246 arbitrary units | Standard Error 0.123 |
| Optive Normal | Contrast Sensitivity | Week 1 | -0.373 arbitrary units | Standard Error 0.111 |
| Soothe Normal | Contrast Sensitivity | Week 2 | -0.232 arbitrary units | Standard Error 0.138 |
| Soothe Normal | Contrast Sensitivity | Week 4 | -0.366 arbitrary units | Standard Error 0.144 |
| Soothe Normal | Contrast Sensitivity | Baseline | -0.169 arbitrary units | Standard Error 0.133 |
| Soothe Normal | Contrast Sensitivity | Week 1 | -0.118 arbitrary units | Standard Error 0.148 |
| New Emulsion Normal | Contrast Sensitivity | Baseline | -0.313 arbitrary units | Standard Error 0.094 |
| New Emulsion Normal | Contrast Sensitivity | Week 4 | -0.098 arbitrary units | Standard Error 0.074 |
| New Emulsion Normal | Contrast Sensitivity | Week 2 | -0.178 arbitrary units | Standard Error 0.139 |
| New Emulsion Normal | Contrast Sensitivity | Week 1 | -0.290 arbitrary units | Standard Error 0.081 |
| Optive Dry Eye | Contrast Sensitivity | Week 1 | -0.275 arbitrary units | Standard Error 0.083 |
| Optive Dry Eye | Contrast Sensitivity | Week 4 | -0.433 arbitrary units | Standard Error 0.079 |
| Optive Dry Eye | Contrast Sensitivity | Baseline | -0.264 arbitrary units | Standard Error 0.117 |
| Optive Dry Eye | Contrast Sensitivity | Week 2 | -0.156 arbitrary units | Standard Error 0.076 |
| Soothe Dry Eye | Contrast Sensitivity | Week 1 | -0.289 arbitrary units | Standard Error 0.113 |
| Soothe Dry Eye | Contrast Sensitivity | Baseline | -0.268 arbitrary units | Standard Error 0.081 |
| Soothe Dry Eye | Contrast Sensitivity | Week 2 | -0.226 arbitrary units | Standard Error 0.057 |
| Soothe Dry Eye | Contrast Sensitivity | Week 4 | -0.193 arbitrary units | Standard Error 0.051 |
| New Emulsion Dry Eye | Contrast Sensitivity | Baseline | -0.364 arbitrary units | Standard Error 0.063 |
| New Emulsion Dry Eye | Contrast Sensitivity | Week 1 | -0.446 arbitrary units | Standard Error 0.09 |
| New Emulsion Dry Eye | Contrast Sensitivity | Week 4 | -0.386 arbitrary units | Standard Error 0.135 |
| New Emulsion Dry Eye | Contrast Sensitivity | Week 2 | -0.308 arbitrary units | Standard Error 0.109 |