Corneal UlcerNCT01104961
Studying the Relationship Between Contact Lens Packaging Solutions and Bacterial Binding to Surface Eye Cells
A study testing Contact lens packaging solution and Balanced salt solution (BSS) in people with Corneal Ulcer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The goal of this study is to investigate the overall theory that the use of chemically preserved solutions associated with contact lenses promotes an increase in bacterial infection. Read more about this study
- Who is it for?
- Ages 18 to 38 yearsHealthy volunteers can take part
- Conditions the study is for
- Corneal Ulcer
- What is being tested?
- Contact lens packaging solution and Balanced salt solution (BSS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Aug 2010
- 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 38 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range: 18-38 years
- Any sex, race or national origin accepted as with our past studies. Minority representation will be proactively encouraged.
- No prior history of any contact lens wear within one month of entry into the study.
- No history of allergic eye disease either seasonal or associated with previous contact lens wear.
Who cannot join
- Any patient that is a current contact lens wearer.
- Patients with active ocular infection or inflammatory disease, history of herpetic keratitis, glaucoma, etc.
- Uncontrolled systemic disease or the presence of any significant illness or condition that could, in the judgment of the investigator, interfere with interpretation of the study results.
- Any patient using ocular tears, anti-histamine based ocular therapies, glaucoma therapy, vasoconstricting drops, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Masked, Randomized, Prospective, Single Center Crossover Clinical Trial on the Relationship Between Chemically Preserved Contact Lens Packaging Solutions and Bacterial Binding to Corneal Epithelial Cells
The goal of this study is to investigate the overall theory that the use of chemically preserved solutions associated with contact lenses promotes an increase in bacterial infection.
Read the detailed description
The purpose of this study is to investigate the theory of bacterial binding to surface eye cells through the use of chemically preserved solutions.
- Conditions
- Corneal Ulcer
- Being tested
- Contact lens packaging solution, Balanced salt solution (BSS)
- Keywords
- Bacterial infection, Loss of epithelial cells
- Medical subject headings
- Corneal Ulcer, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contact lens packaging solutionDevice
Also called Blister pack solution
These test solutions are the intervention being tested.
Balanced salt solution (BSS)Device
Also called Saline solution
BSS is isotonic to the tissues of the eyes.
| Study group | Role | What they receive |
|---|---|---|
| Contact Lens Packaging Solution #1 | Experimental | Test solution - contact lens packaging solution Receives: Device: Contact lens packaging solution |
| Contact lens packaging solution #2 | Experimental | Test solution - contact lens packaging solution Receives: Device: Contact lens packaging solution |
| Balanced salt solution | Placebo comparator | Control solution Receives: Device: Balanced salt solution (BSS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial binding of Pseudomonas Aeruginosa
Counting the number of bacteria that bind to surface epithelial cells.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionAug 2010
- Study completionAug 2010
Why it stopped: Other projects took precedence, no mechanism of funding establed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal UlcerStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danielle Robertson, University of Texas Southwestern Medical Center
- Investigators
- Danielle Robertson, OD, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104961
- Sponsor's protocol ID
- 032010-081
- Status last verified
- Aug 2018
- First submitted
- 9 Apr 2010
- Last updated
- 17 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Masked, Randomized, Prospective, Single Center Crossover Clinical Trial on the Relationship Between Chemically Preserved Contact Lens Packaging Solutions and Bacterial Binding to Corneal Epithelial Cells
- ClinicalTrials.gov ID
- NCT01104961
- Acronym / sponsor ID
- 032010-081
- Conditions
- Corneal Ulcer
- Keywords
- Bacterial infection, Loss of epithelial cells
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Other projects took precedence, no mechanism of funding establed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 16 Apr 2010 (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 goal of this study is to investigate the overall theory that the use of chemically preserved solutions associated with contact lenses promotes an increase in bacterial infection.
Detailed description
The purpose of this study is to investigate the theory of bacterial binding to surface eye cells through the use of chemically preserved solutions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Contact Lens Packaging Solution #1 | Experimental | Device: Contact lens packaging solutionTest solution - contact lens packaging solution |
| Contact lens packaging solution #2 | Experimental | Device: Contact lens packaging solutionTest solution - contact lens packaging solution |
| Balanced salt solution | Placebo comparator | Device: Balanced salt solution (BSS)Control solution |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age range: 18-38 years
- Any sex, race or national origin accepted as with our past studies. Minority representation will be proactively encouraged.
- No prior history of any contact lens wear within one month of entry into the study.
- No history of allergic eye disease either seasonal or associated with previous contact lens wear.
Key exclusion criteria (4 listed)
- Any patient that is a current contact lens wearer.
- Patients with active ocular infection or inflammatory disease, history of herpetic keratitis, glaucoma, etc.
- Uncontrolled systemic disease or the presence of any significant illness or condition that could, in the judgment of the investigator, interfere with interpretation of the study results.
- Any patient using ocular tears, anti-histamine based ocular therapies, glaucoma therapy, vasoconstricting drops, etc.
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 |
|---|---|---|
| Contact lens packaging solutionAlso: Blister pack solutionThese test solutions are the intervention being tested. | Device | Contact Lens Packaging Solution #1, Contact lens packaging solution #2 |
| Balanced salt solution (BSS)Also: Saline solutionBSS is isotonic to the tissues of the eyes. | Device | Balanced salt solution |
Primary outcome
Bacterial binding of Pseudomonas Aeruginosa
Time frame: 5 weeks
Counting the number of bacteria that bind to surface epithelial cells.
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 17 Aug 2018.
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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.
Danielle Robertson, OD, PhD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contact lens packaging solution and Balanced salt solution (BSS) in people with Corneal Ulcer, run by University of Texas Southwestern Medical Center 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 4 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: withdrawn, as of the sponsor's last update on 17 Aug 2018. 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?
Bacterial binding of Pseudomonas Aeruginosa (time frame: 5 weeks). 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 17 Aug 2018; AzTrials last refreshed its copy on 1 Nov 2026.