An interventional study of Optive, Soothe, New Emulsion and Soothe, New Emulsion, Optive in Dry Eye Syndrome, sponsored by Southern California College of Optometry at Marshall B. Ketchum University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-12.
Sponsored by Southern California College of Optometry at Marshall B. Ketchum University · Not applicable, Interventional, and Basic science
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.
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.
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Southern California College of Optometry at Marshall B. Ketchum University is the lead sponsor of 19 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Subjects do not use artificial tears for one week followed by 1 month using Optive two times per day. One week washout then 1 month Soothe two times per day followed by one week washout and one month New Emulsion 2 times per day.
Other: Optive, Soothe, New Emulsion
Subjects do not use artificial tears for one week followed by 1 month using Soothe two times per day. One week washout then 1 month New Emulsion two times per day followed by one week washout and one month Optive 2 times per day.
Other: Soothe, New Emulsion, Optive
Subjects do not use artificial tears for one week followed by 1 month using New Emulsion two times per day. One week washout then 1 month Optive two times per day followed by one week washout and one month Soothe 2 times per day.
Other: New Emulsion, Optive, Soothe
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.
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.
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.
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
Subjects were recruited from the patients and staff of the clinic. The recruitment period was from 10/1/2009 till 7/30/2010.
| Milestone | Optive, Soothe, New Emulsion | Soothe, New Emulsion, Optive | New Emulsion, Optive, Soothe |
|---|---|---|---|
| Started | 7 | 7 | 6 |
| Completed | 7 | 7 | 6 |
| Not completed | 0 | 0 | 0 |
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.
| arbitrary units | Optive Normal | Soothe Normal | New Emulsion Normal | Optive Dry Eye | Soothe Dry Eye | New Emulsion Dry Eye |
|---|---|---|---|---|---|---|
| Baseline | -0.375 ± 0.139 | -0.169 ± 0.133 | -0.313 ± 0.094 | -0.264 ± 0.117 | -0.268 ± 0.081 | -0.364 ± 0.063 |
| Week 1 | -0.373 ± 0.111 | -0.118 ± 0.148 | -0.290 ± 0.081 | -0.275 ± 0.083 | -0.289 ± 0.113 | -0.446 ± 0.090 |
| Week 2 | -0.186 ± 0.109 | -0.232 ± 0.138 | -0.178 ± 0.139 | -0.156 ± 0.076 | -0.226 ± 0.057 | -0.308 ± 0.109 |
| Week 4 | -0.246 ± 0.123 | -0.366 ± 0.144 | -0.098 ± 0.074 | -0.433 ± 0.079 | -0.193 ± 0.051 | -0.386 ± 0.135 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Optive | — | 0/20 (0%) | 0/20 (0%) |
| Soothe | — | 0/20 (0%) | 0/20 (0%) |
| New Emulsion | — | 0/20 (0%) | 0/20 (0%) |
The data from each drop was combined for all arms.
| Age, Categorical(Participants) | Optive, Soothe, New Emulsion | Soothe, New Emulsion, Optive | New Emulsion, Optive, Soothe | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 7 | 6 | 20 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Optive, Soothe, New Emulsion | Soothe, New Emulsion, Optive | New Emulsion, Optive, Soothe | Total |
|---|---|---|---|---|
| Mean | 23.8 ± 1.60 | 22.6 ± 1.67 | 24.4 ± 2.07 | 23.6 ± 1.82 |
| Sex: Female, Male(Participants) | Optive, Soothe, New Emulsion | Soothe, New Emulsion, Optive | New Emulsion, Optive, Soothe | Total |
|---|---|---|---|---|
| Female | 7 | 6 | 4 | 17 |
| Male | 0 | 1 | 2 | 3 |
| Region of Enrollment(participants) | Optive, Soothe, New Emulsion | Soothe, New Emulsion, Optive | New Emulsion, Optive, Soothe | Total |
|---|---|---|---|---|
| United States | 7 | 7 | 6 | 20 |
Plan to share: No — All data is available upon request.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Southern California College of Optometry at Marshall B. Ketchum University