Corneal Epithelial DisruptionNCT00381446
Evaluation of Corneal Staining With Various Contact Lens/Solution Combinations
A study testing Marketed contact lens care products in people with Corneal Epithelial Disruption and Corneal Staining, run by Andrasko, Gary, OD, LLC at 1 site in United States.
Trial summary
The purpose of this study is to quantify the amount of corneal staining observed with various marketed contact lens/multipurpose solution combinations. The hypothesis is that there are measurable differences in the amount of corneal staining between the various combinations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Corneal Epithelial Disruption, Corneal Staining
- What is being tested?
- Marketed contact lens care products
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Mar 2008
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- currently wearing soft contact lenses daily wear for at least 2 weeks prior to study
- correct visual acuity of 20/30 or better each eye
Who cannot join
- history of hypersensitivity to any components of solution being tested
- any ocular condition prohibiting contact lens wear
- excessive baseline staining as defined in protocol
- use of topical or OTC ocular medications during the study
- seasonal allergies with significant effect on contact lens wear
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Dr. Richard Erdey office
Columbus, Ohio, 43213
Gary J. Andrasko, OD, MS, 614-459-3363, gandrask@columbus.rr.com
About this study
Official title: Evaluation of Corneal Staining With Market Contact Lens/Solution Combinations
The purpose of this study is to quantify the amount of corneal staining observed with various marketed contact lens/multipurpose solution combinations. The hypothesis is that there are measurable differences in the amount of corneal staining between the various combinations.
Read the detailed description
A series of clinical studies is being conducted at one research site using a double-masked, randomized cross-over design. Each study consists of asymptomatic daily wear soft contact lens wearers observed at baseline and at two and four hours post lens insertion. Corneal staining is being assessed using sodium fluorescein, a cobalt filter and a yellow filter. Subjective comfort assessments are obtained at each visit.
- Conditions
- Corneal Epithelial Disruption, Corneal Staining
- Being tested
- Marketed contact lens care products
- Keywords
- corneal staining, contact lens care, multipurpose solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marketed contact lens care productsDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Area of Corneal Staining
Secondary outcomes (1)
Type (severity) of Corneal Staining
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2006 (estimated)
- Study startJul 2005
- Study completionMar 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal Epithelial DisruptionStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrasko, Gary, OD, LLC
- Collaborators
- Alcon Research
- Investigators
- Gary J. Andrasko, OD, MS, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00381446
- Sponsor's protocol ID
- MS005
- Status last verified
- Sep 2007
- First submitted
- 25 Sep 2006
- Last updated
- 27 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Corneal Staining With Market Contact Lens/Solution Combinations
- ClinicalTrials.gov ID
- NCT00381446
- Acronym / sponsor ID
- MS005
- Conditions
- Corneal Epithelial Disruption, Corneal Staining
- Keywords
- corneal staining, contact lens care, multipurpose solution
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Andrasko, Gary, OD, LLC
- Collaborators
- Alcon Research
- Study start
- Jul 2005
- Study completion
- Mar 2008 (estimated)
- First posted
- 27 Sep 2006 (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 purpose of this study is to quantify the amount of corneal staining observed with various marketed contact lens/multipurpose solution combinations. The hypothesis is that there are measurable differences in the amount of corneal staining between the various combinations.
Detailed description
A series of clinical studies is being conducted at one research site using a double-masked, randomized cross-over design. Each study consists of asymptomatic daily wear soft contact lens wearers observed at baseline and at two and four hours post lens insertion. Corneal staining is being assessed using sodium fluorescein, a cobalt filter and a yellow filter. Subjective comfort assessments are obtained at each visit.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- currently wearing soft contact lenses daily wear for at least 2 weeks prior to study
- correct visual acuity of 20/30 or better each eye
Key exclusion criteria (5 listed)
- history of hypersensitivity to any components of solution being tested
- any ocular condition prohibiting contact lens wear
- excessive baseline staining as defined in protocol
- use of topical or OTC ocular medications during the study
- seasonal allergies with significant effect on contact lens wear
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 |
|---|---|---|
| Marketed contact lens care products | Device | – |
Primary outcome
Area of Corneal Staining
1 secondary outcome
Type (severity) of Corneal Staining
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2007.
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.
Gary J. Andrasko, OD, MS principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Marketed contact lens care products in people with Corneal Epithelial Disruption and Corneal Staining, run by Andrasko, Gary, OD, LLC 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Sep 2007. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gary J. Andrasko, OD, MS (614-459-3363, gandrask@columbus.rr.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area of Corneal Staining. 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 27 Sep 2007.