Dry Eye DiseaseNCT00553579
The Relationship of Residence Time and Visual Effect of Optive and Systane in Dry Eye Subjects
An observational study of Dry Eye Disease, run by Southern California College of Optometry at Marshall B. Ketchum University at 1 site in United States.
Trial summary
The benefits of artificial tears to relieve dry eye symptoms include, but are not limited to: stabilizing the tear film layer, fluid supplement action, improving visual acuity, and comfort. Studies have found a relationship between some of these benefits. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to May 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: The subjects for this investigation will be sourced from an existing, secure dry eye subject database. These subjects will have been screened for dry eye using a consistent protocol (Diagnostic monograph, J. Paugh, January 2007). Subjects who have taken part in a prior study undergoing this same eligibility visit protocol within the past 18 months will not be required to repeat the visit.
Who may be able to join
- There are no requirements as to subject race, gender or occupation. All subjects must meet the following criteria:
- The informed consent document must be read, signed and dated by the subject or legally authorized representative before conducting any procedures. Additionally, the informed consent document must be signed and dated by the individual obtaining consent of the subject.
- Adult subjects, > age 18 years, with mild-to-moderate dry eye. Criteria for the diagnosis must include two of the three following characteristics as demonstrated at the Eligibility Visit:
- Composite symptom score of ≥ 7 on the Schein Questionnaire:
- Sodium Fluorescein (NaFl) Tear Break-Up Time ≤ 7 seconds in either (worse) eye
- Cumulative Sodium Fluorescein (NaFl) Corneal Staining ≥ 4 in either (worse) eye on a 0-20 point scale (corresponds to ≥ 3 on a 0-15 scale).
- Able and willing to follow study instructions.
- Subjects must have best corrected visual acuity of 20/25 or better in each eye as assessed using an ETDRS chart.
Who cannot join
- Subjects demonstrating any medical condition that may affect the results of this study will NOT be enrolled. The following are specific conditions that exclude subjects from enrollment in this study.
- History or evidence of ocular or intraocular surgery in either eye within the past six months. LASIK and other keratorefractive procedure patients can qualify if the most recent surgery or enhancement was 12 or more months prior.
- History or evidence of serious ocular trauma in either eye within the past six months.
- History of hypersensitivity to any component of the study medications: History of hypersensitivity to any component of Optive® Artificial Tears, Systane® Artificial Tears, diagnostic dyes sodium fluorescein and fluorescein isothiocyanate dextran.
- History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia, active or recent varicella, viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva; mycobacterial infection of the eye; and/or fungal disease of the eye.
- Use of concomitant topical ocular medications during the study period.
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- Subjects using systemic steroids, immunosuppressive agents and/or anti-cholinergics (e.g. cold and allergy medications, tricyclic antidepressants) for treatment of autoimmune connective tissue disease may not be enrolled in the study if they have not been on a stable dosing regimen for a minimum of 30 days prior to the Eligibility Visit. In addition, the dosing regimen must remain stable throughout the study period.
- Ocular conditions such as conjunctival infections, or iritis.
- Individuals unwilling to discontinue contact lens wear for 2 days prior to each visit during the study period.
- Participation in an investigational drug or device study within 30 days of entering this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern California College of Optometry
Fullerton, California, 92831
About this study
The benefits of artificial tears to relieve dry eye symptoms include, but are not limited to: stabilizing the tear film layer, fluid supplement action, improving visual acuity, and comfort. Studies have found a relationship between some of these benefits. For example, stabilization of the tear film is important not only to increase the tear break up time (TBUT), but is key in improving and maintaining visual acuity. These studies have alluded to the fact that there may or may not be a relationship between residence time and visual performance. Viscosity is one reason behind the uncertainty. Some solutions contain polymers which influence the ocular surface when contacted. This can impact residence time and ultimately visual performance. No prior research has explored the direct relationship between residence time and visual performance.
Residence time refers to the duration at which the artificial tear resides on the eye. Methods have been developed to assess residence time by admixing fluorescent tracers to the solution and then measuring the amount of fluorescence over time. The caveat to methods using certain tracers has lead to uncertainty in elimination measurements due to corneal penetration or differing molecular weights (MW) from the active vehicle ingredient in the solution. For example, low-MW tracers can be eliminated at a different rate than higher-MW polymers. In addition, the low-MW tracers may be able to penetrate the corneal epithelium giving a false pre-corneal residence time. Meadows, Paugh, Joshi, and Mordaunt addressed this issue by developing a technique using a polymer which did not penetrate the cornea and had the same MW as the active ingredient in the solution FITC-dextran. Based on the assumption that similar weights are eliminated at the same rate, this technique has shown to be more economic, manageable, and amendable than previous procedures measuring residence time.
Read more
Any ophthalmic drop has the potential to impact visual acuity upon instillation due to the effect it has on the tear layer components. Studies have observed that taking artificial tears continuously over time tends to stabilize the tear layer thus minimizing the immediate drop in contrast sensitivity upon instillation. Measuring the visual effect of artificial tears, using contrast sensitivity as a measure, provides valuable information about the therapeutic effect of artificial tears that are meant to stabilize the tear film, thus improving visual acuity in dry eye patients.
But what about the patient? There is a difference between residence time and retention of effect- which is often what matters the most for patients. Retention of effect refers to the beneficial effect of the drop. Currently there is no real measure of retention of effect. Doctors can assess the tear film objectively, but there have been no strong correlations between subjective dry symptoms and tear film stability. A possible reason for the lack of correlation may be due to the fact that subjectivity is difficult to quantify. However, scales like the Visual Analog Scale (VAS) and Numerical Rating Scale (NRS) have been established in an attempt to quantify subjective experiences such as visual quality. We will be using the NRS to gauge the comfort of the drop upon the initial application to get a general idea of the comfort the drop provides to the user.
Although there have been several studies done on residence time and visual effect of ophthalmic formulations separately, there is no current research correlating these two aspects of therapeutic efficacy. This study will be the first to concurrently investigate residence time (using FITC-dextran) and visual effect of an ophthalmic formulation.
- Conditions
- Dry Eye Disease
- Keywords
- contrast sensitivity, retention time
- 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.
| Study group | Role | What they receive |
|---|---|---|
| DE | All subjects will have clinically significant dry eye. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The principal outcome parameters will be gross residence time in minutes and the effect on contrast sensitivity time in minutes.
Measured: 1 hour
Secondary outcomes (1)
A secondary outcome variable will be the comfort value (NRS) of the initial drop application.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2007 (estimated)
- Study startJun 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern California College of Optometry at Marshall B. Ketchum University
- Sponsor type
- University, hospital or other
- Investigators
- William Ridder, OD, PhD, Principal investigator, Southern California College of Optometry at Marshall B. Ketchum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553579
- Sponsor's protocol ID
- SCCO2-2241
- Status last verified
- May 2008
- First submitted
- 1 Nov 2007
- Last updated
- 20 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Residence Time and Visual Effect of Optive and Systane in Dry Eye Subjects
- ClinicalTrials.gov ID
- NCT00553579
- Acronym / sponsor ID
- SCCO2-2241
- Conditions
- Dry Eye Disease
- Keywords
- contrast sensitivity, retention time
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Southern California College of Optometry at Marshall B. Ketchum UniversityUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 5 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The benefits of artificial tears to relieve dry eye symptoms include, but are not limited to: stabilizing the tear film layer, fluid supplement action, improving visual acuity, and comfort. Studies have found a relationship between some of these benefits. For example, stabilization of the tear film is important not only to increase the tear break up time (TBUT), but is key in improving and maintaining visual acuity. These studies have alluded to the fact that there may or may not be a relationship between residence time and visual performance. Viscosity is one reason behind the uncertainty. Some solutions contain polymers which influence the ocular surface when contacted. This can impact residence time and ultimately visual performance. No prior research has explored the direct relationship between residence time and visual performance.
Residence time refers to the duration at which the artificial tear resides on the eye. Methods have been developed to assess residence time by admixing fluorescent tracers to the solution and then measuring the amount of fluorescence over time. The caveat to methods using certain tracers has lead to uncertainty in elimination measurements due to corneal penetration or differing molecular weights (MW) from the active vehicle ingredient in the solution. For example, low-MW tracers can be eliminated at a different rate than higher-MW polymers. In addition, the low-MW tracers may be able to penetrate the corneal epithelium giving a false pre-corneal residence time. Meadows, Paugh, Joshi, and Mordaunt addressed this issue by developing a technique using a polymer which did not penetrate the cornea and had the same MW as the active ingredient in the solution FITC-dextran. Based on the assumption that similar weights are eliminated at the same rate, this technique has shown to be more economic, manageable, and amendable than previous procedures measuring residence time.
Any ophthalmic drop has the potential to impact visual acuity upon instillation due to the effect it has on the tear layer components. Studies have observed that taking artificial tears continuously over time tends to stabilize the tear layer thus minimizing the immediate drop in contrast sensitivity upon instillation. Measuring the visual effect of artificial tears, using contrast sensitivity as a measure, provides valuable information about the therapeutic effect of artificial tears that are meant to stabilize the tear film, thus improving visual acuity in dry eye patients.
But what about the patient? There is a difference between residence time and retention of effect- which is often what matters the most for patients. Retention of effect refers to the beneficial effect of the drop. Currently there is no real measure of retention of effect. Doctors can assess the tear film objectively, but there have been no strong correlations between subjective dry symptoms and tear film stability. A possible reason for the lack of correlation may be due to the fact that subjectivity is difficult to quantify. However, scales like the Visual Analog Scale (VAS) and Numerical Rating Scale (NRS) have been established in an attempt to quantify subjective experiences such as visual quality. We will be using the NRS to gauge the comfort of the drop upon the initial application to get a general idea of the comfort the drop provides to the user.
Although there have been several studies done on residence time and visual effect of ophthalmic formulations separately, there is no current research correlating these two aspects of therapeutic efficacy. This study will be the first to concurrently investigate residence time (using FITC-dextran) and visual effect of an ophthalmic formulation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DE | – | –All subjects will have clinically significant dry eye. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects for this investigation will be sourced from an existing, secure dry eye subject database. These subjects will have been screened for dry eye using a consistent protocol (Diagnostic monograph, J. Paugh, January 2007). Subjects who have taken part in a prior study undergoing this same eligibility visit protocol within the past 18 months will not be required to repeat the visit.
Key inclusion criteria (8 listed)
- There are no requirements as to subject race, gender or occupation. All subjects must meet the following criteria:
Key exclusion criteria (10 listed)
- Subjects demonstrating any medical condition that may affect the results of this study will NOT be enrolled. The following are specific conditions that exclude subjects from enrollment in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The principal outcome parameters will be gross residence time in minutes and the effect on contrast sensitivity time in minutes.
Time frame: 1 hour
1 secondary outcome
A secondary outcome variable will be the comfort value (NRS) of the initial drop application.
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2008.
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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 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?
An observational study of Dry Eye Disease, 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 8 inclusion and 10 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 20 May 2008. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The principal outcome parameters will be gross residence time in minutes and the effect on contrast sensitivity time in minutes. (time frame: 1 hour). 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 20 May 2008.