Dry Eye SyndromeNCT00812721
Tears Substitutions and Their Effects on Higher Order Aberrometery
A study testing Preservative Free Saline, Optive and Refresh Moderate/Severe in people with Dry Eye Syndrome, run by Gina Rogers at 1 site in United States.
Trial summary
Hypothesis is that tear substitutions cause blur after they are instilled. The investigators will use aberrometry as a measurement over time after a tear formulation is used and try to determine if there are any measurable change in higher order aberrations between different tear formulations and how long it takes to… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- Preservative Free Saline, Optive and Refresh Moderate/Severe
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jul 2009
- Phase
- Interventional
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects that do not have any complaints of dry eye and confirmed by ocular surface disease index questionnaire.
- Visually correctable to 20/20 in each eye.
- Non contact lens wearer.
- No history of systemic disease associated with dry eye syndromes.
- No current use of ocular medications.
- Adult volunteers who agree to HIPAA standards and sign informed consent.
Who cannot join
- Patients that have dry eye symptoms or slitlamp findings consistent with dry eye.
- Have a systemic condition that is associated with dry eye syndromes.
- Take systemic medications that have dry as a side effect
- Currently use artificial tears.
- Currently are using ocular medications.
- Currently wear contact lenses.
- Enrollment of the investigator's office staff, relatives, or members of their respective households.
- Enrollment of more than one member of the same household.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Department of Ophthalmology and Visual Sciences
Iowa City, Iowa, 52242
About this study
Hypothesis is that tear substitutions cause blur after they are instilled. The investigators will use aberrometry as a measurement over time after a tear formulation is used and try to determine if there are any measurable change in higher order aberrations between different tear formulations and how long it takes to return to pre-instillation measurements thus providing information on duration of the tear drop. 4 commercially available "dry eye" artificial tears formulations will be used and preservative saline will act as a control. The study will be conducted on subjects that do not have clinical evidence of dry eye syndrome to focus the data on the blur effects of the tear substitutions.
Read the detailed description
Once consent is obtained the subject will choose from available time slots. Each subject will come to the UIHC Department of Ophthalmology at designated times for approximately one hour on five different days, for a total time commitment of approximately 5 hours. Each subject will receive the same 4 artificial tear substitutes and saline, one different drop each day. One of the four tear substitutes (brands: Systane, Systane Ultra, Optive, and Refresh) will be tested on each of the days. One drop will be used each day and the protocol of each day will be the same, the only factor changing from day to day is the drop that is being evaluated. On each study day, the subject will have a pre-instillation measurement of their higher order aberrometry of each eye. One drop of the designated drop will be placed into each of the eyes. Subsequent aberrometry measurements of each eye will be taken at immediately post-instillation, 5 minutes, 30 minutes and 60 minutes post instillation. The same protocol will be followed with a saline drop and thus each patient will act as a control.
There is no long-term follow-up.
- Conditions
- Dry Eye Syndrome
- Being tested
- Preservative Free Saline, Optive, Refresh Moderate/Severe, Systane, Systane Ultra
- Keywords
- higher order aberrations, tear blur
- 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.
Preservative Free SalineOther
One drop will be instilled into each eye once
OptiveOther
One drop will be instilled into each eye once
Refresh Moderate/SevereOther
One drop will be instilled into each eye once
SystaneOther
One drop will be instilled into each eye once
Systane UltraOther
One drop will be instilled into each eye once
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Preservative Free Saline Receives: Other: Preservative Free Saline |
| 2 | Active comparator | Optive (TM) Receives: Other: Optive |
| 3 | Active comparator | Refresh Moderate/Severe (TM) Receives: Other: Refresh Moderate/Severe |
| 4 | Active comparator | Systane (TM) Receives: Other: Systane |
| 5 | Active comparator | Systane Ultra (TM) Receives: Other: Systane Ultra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of a subject's higher order aberrations over time is the primary outcome measure
Measured: pre drop instillation, 1, 5, 15, 30, and 60 minutes post instillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionJun 2009 (estimated)
- Study completionJul 2009 (estimated)
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gina Rogers
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gina Rogers, University of Iowa
- Investigators
- Gina M Rogers, MD, Principal investigator, University of Iowa Department of Ophthalmology and Visual SciencesChristine Sindt, OD, Study director, niversity of Iowa Department of Ophthalmology and Visual Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00812721
- Sponsor's protocol ID
- Iowa RR 01
- Status last verified
- Mar 2017
- First submitted
- 18 Dec 2008
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tears Substitutions and Their Effects on Higher Order Aberrometery
- ClinicalTrials.gov ID
- NCT00812721
- Acronym / sponsor ID
- Iowa RR 01
- Conditions
- Dry Eye Syndrome
- Keywords
- higher order aberrations, tear blur
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Gina RogersUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 22 Dec 2008 (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.
Hypothesis is that tear substitutions cause blur after they are instilled. The investigators will use aberrometry as a measurement over time after a tear formulation is used and try to determine if there are any measurable change in higher order aberrations between different tear formulations and how long it takes to return to pre-instillation measurements thus providing information on duration of the tear drop. 4 commercially available "dry eye" artificial tears formulations will be used and preservative saline will act as a control. The study will be conducted on subjects that do not have clinical evidence of dry eye syndrome to focus the data on the blur effects of the tear substitutions.
Detailed description
Once consent is obtained the subject will choose from available time slots. Each subject will come to the UIHC Department of Ophthalmology at designated times for approximately one hour on five different days, for a total time commitment of approximately 5 hours. Each subject will receive the same 4 artificial tear substitutes and saline, one different drop each day. One of the four tear substitutes (brands: Systane, Systane Ultra, Optive, and Refresh) will be tested on each of the days. One drop will be used each day and the protocol of each day will be the same, the only factor changing from day to day is the drop that is being evaluated. On each study day, the subject will have a pre-instillation measurement of their higher order aberrometry of each eye. One drop of the designated drop will be placed into each of the eyes. Subsequent aberrometry measurements of each eye will be taken at immediately post-instillation, 5 minutes, 30 minutes and 60 minutes post instillation. The same protocol will be followed with a saline drop and thus each patient will act as a control.
There is no long-term follow-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Other: Preservative Free SalinePreservative Free Saline |
| 2 | Active comparator | Other: OptiveOptive (TM) |
| 3 | Active comparator | Other: Refresh Moderate/SevereRefresh Moderate/Severe (TM) |
| 4 | Active comparator | Other: SystaneSystane (TM) |
| 5 | Active comparator | Other: Systane UltraSystane Ultra (TM) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects that do not have any complaints of dry eye and confirmed by ocular surface disease index questionnaire.
- Visually correctable to 20/20 in each eye.
- Non contact lens wearer.
- No history of systemic disease associated with dry eye syndromes.
- No current use of ocular medications.
Key exclusion criteria (8 listed)
- Patients that have dry eye symptoms or slitlamp findings consistent with dry eye.
- Have a systemic condition that is associated with dry eye syndromes.
- Take systemic medications that have dry as a side effect
- Currently use artificial tears.
- Currently are using ocular medications.
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 |
|---|---|---|
| Preservative Free SalineOne drop will be instilled into each eye once | Other | 1 |
| OptiveOne drop will be instilled into each eye once | Other | 2 |
| Refresh Moderate/SevereOne drop will be instilled into each eye once | Other | 3 |
| SystaneOne drop will be instilled into each eye once | Other | 4 |
| Systane UltraOne drop will be instilled into each eye once | Other | 5 |
Primary outcome
Measurement of a subject's higher order aberrations over time is the primary outcome measure
Time frame: pre drop instillation, 1, 5, 15, 30, and 60 minutes post instillation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
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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.
Gina M Rogers, MD principal investigator
University of Iowa Department of Ophthalmology and Visual Sciences
Christine Sindt, OD study director
niversity of Iowa Department of Ophthalmology and Visual Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preservative Free Saline, Optive and Refresh Moderate/Severe in people with Dry Eye Syndrome, run by Gina Rogers 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 6 inclusion and 8 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: withdrawn, as of the sponsor's last update on 4 Apr 2017. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Measurement of a subject's higher order aberrations over time is the primary outcome measure (time frame: pre drop instillation, 1, 5, 15, 30, and 60 minutes post instillation). 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 4 Apr 2017.