Dry Eye SyndromeNCT01013077
The Effect of a New Emulsion in Dry Eye Patients on Tear Layer Aberrometry, Contrast Sensitivity, and Reading Ability
A study testing Optive, Soothe, New Emulsion, Soothe, New Emulsion, Optive and New Emulsion, Optive, Soothe in people with Dry Eye Syndrome, run by Southern California College of Optometry at Marshall B. Ketchum University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- Optive, Soothe, New Emulsion, Soothe, New Emulsion, Optive and New Emulsion, Optive, Soothe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Aug 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- mild, moderate, or severe symptoms of dry eye
Who cannot join
- uncontrolled systemic disease
- contact lens wear
- participation in another clinical trial
- best corrected visual acuity poorer than 20/25
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern California College of Optometry
Fullerton, California, 92831
About this study
Official title: The Effect of a New Emulsion in Dry Eye Patients on Tear Layer Aberrometry, Contrast Sensitivity, and Reading Ability.
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.
Read the 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.
- Conditions
- Dry Eye Syndrome
- Being tested
- Optive, Soothe, New Emulsion, Soothe, New Emulsion, Optive, New Emulsion, Optive, Soothe
- Keywords
- functional vision, contrast sensitivity, aberrometry, reading ability
- 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.
Optive, Soothe, New EmulsionOther
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.
Soothe, New Emulsion, OptiveOther
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.
New Emulsion, Optive, SootheOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Optive, Soothe, New Emulsion | Experimental | 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. Receives: Other: Optive, Soothe, New Emulsion |
| Soothe, New Emulsion, Optive | Experimental | 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. Receives: Other: Soothe, New Emulsion, Optive |
| New Emulsion, Optive, Soothe | Experimental | 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. Receives: Other: New Emulsion, Optive, Soothe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 week, 2 weeks, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionMar 2011
- Study completionAug 2011
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromeStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern California College of Optometry at Marshall B. Ketchum University
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, William Ridder, Southern California College of Optometry at Marshall B. Ketchum University
- Investigators
- William H. Ridder, OD, PhD, Principal investigator, Southern California College of Optometry at Marshall B. Ketchum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01013077
- Sponsor's protocol ID
- 09-11
- Status last verified
- Jun 2025
- First submitted
- 11 Nov 2009
- Last updated
- 12 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: All data is available upon request.
Publications
Thai LC, Tomlinson A, Ridder WH. Contact lens drying and visual performance: the vision cycle with contact lenses. Optom Vis Sci. 2002 Jun;79(6):381-8. doi: 10.1097/00006324-200206000-00012.
PubMed 12086305Ridder WH 3rd, Lamotte JO, Ngo L, Fermin J. Short-term effects of artificial tears on visual performance in normal subjects. Optom Vis Sci. 2005 May;82(5):370-377. doi: 10.1097/01.OPX.0000162646.30666.E3.
PubMed 15894913Ridder WH 3rd, LaMotte J, Hall JQ Jr, Sinn R, Nguyen AL, Abufarie L. Contrast sensitivity and tear layer aberrometry in dry eye patients. Optom Vis Sci. 2009 Sep;86(9):E1059-68. doi: 10.1097/OPX.0b013e3181b599bf.
PubMed 19648840
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a New Emulsion in Dry Eye Patients on Tear Layer Aberrometry, Contrast Sensitivity, and Reading Ability.
- ClinicalTrials.gov ID
- NCT01013077
- Acronym / sponsor ID
- 09-11
- Conditions
- Dry Eye Syndrome
- Keywords
- functional vision, contrast sensitivity, aberrometry, reading ability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Southern California College of Optometry at Marshall B. Ketchum UniversityUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Nov 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 13 Nov 2009 (estimated)
- Results
- Posted 12 Jun 2025
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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Optive, Soothe, New Emulsion | Experimental | Other: Optive, Soothe, New EmulsionSubjects 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. |
| Soothe, New Emulsion, Optive | Experimental | Other: Soothe, New Emulsion, OptiveSubjects 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. |
| New Emulsion, Optive, Soothe | Experimental | Other: New Emulsion, Optive, SootheSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- mild, moderate, or severe symptoms of dry eye
Key exclusion criteria (4 listed)
- uncontrolled systemic disease
- contact lens wear
- participation in another clinical trial
- best corrected visual acuity poorer than 20/25
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 |
|---|---|---|
| Optive, Soothe, New EmulsionOne 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. | Other | Optive, Soothe, New Emulsion |
| Soothe, New Emulsion, OptiveOne 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. | Other | Soothe, New Emulsion, Optive |
| New Emulsion, Optive, SootheOne 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. | Other | New Emulsion, Optive, Soothe |
Primary outcome
Contrast Sensitivity
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12086305Thai LC, Tomlinson A, Ridder WH. Contact lens drying and visual performance: the vision cycle with contact lenses. Optom Vis Sci. 2002 Jun;79(6):381-8. doi: 10.1097/00006324-200206000-00012.
- Background: PubMed 15894913Ridder WH 3rd, Lamotte JO, Ngo L, Fermin J. Short-term effects of artificial tears on visual performance in normal subjects. Optom Vis Sci. 2005 May;82(5):370-377. doi: 10.1097/01.OPX.0000162646.30666.E3.
- Background: PubMed 19648840Ridder WH 3rd, LaMotte J, Hall JQ Jr, Sinn R, Nguyen AL, Abufarie L. Contrast sensitivity and tear layer aberrometry in dry eye patients. Optom Vis Sci. 2009 Sep;86(9):E1059-68. doi: 10.1097/OPX.0b013e3181b599bf.
- Individual participant dataSharing planned: No. All data is available upon request.
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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.
William H. Ridder, OD, PhD principal investigator
Southern California College of Optometry at Marshall B. Ketchum 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 Optive, Soothe, New Emulsion, Soothe, New Emulsion, Optive and New Emulsion, Optive, Soothe in people with Dry Eye Syndrome, run by Southern California College of Optometry at Marshall B. Ketchum University 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 1 inclusion and 4 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 12 Jun 2025. 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 12 Jun 2025). 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?
Contrast Sensitivity (time frame: Baseline, 1 week, 2 weeks, 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01013077, which also lists 3 linked publications.
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 12 Jun 2025.