Corneal StainingNCT01100424
Assessment of Tear Film-Based Proteins Associated With Care Solution Induced Corneal Staining
A study testing Opti-Free RepleniSH, ReNu MultiPlus and Balafilcon A in people with Corneal Staining, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study was to investigate the association of inflammatory mediators found in the tear film during the development and following the induction of contact lens solution-induced corneal staining. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Corneal Staining
- What is being tested?
- Opti-Free RepleniSH, ReNu MultiPlus and Balafilcon A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Sep 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- For non-lens wearers:
- Normal eyes.
- Currently not wearing contact lenses and has not worn contact lenses for the previous 6 months.
- Free of dry eye using the Ocular Surface Disease Index (Schiffman et al).
- Other protocol-defined inclusion criteria may apply.
- For contact lens wearers:
Show all 11Show fewer
- Currently wearing soft contact lenses.
- Free of dry eye during lens wear using the Contact Lens Dry Eye Questionnaire Short-Form (Nichols et al, Cornea, 2002).
- Reports a contact lens wearing time of at least 12 hours per day, 7 days per week, daily wear basis (not overnight wear).
- Reports only occasional use of contact lens rewetting drops or artificial tears.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- For non-lens wearers and contact lens wearers:
- Pregnant.
- Participating in another research study.
- Exhibiting staining with fluorescein in more than 5% of the total cornea (graded by "extent" of staining across 5 regions).
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134
About this study
The purpose of this study was to investigate the association of inflammatory mediators found in the tear film during the development and following the induction of contact lens solution-induced corneal staining.
- Conditions
- Corneal Staining
- Being tested
- Opti-Free RepleniSH, ReNu MultiPlus, Balafilcon A, Unisol 4
- Keywords
- Contact lenses, Contact lens solution, Corneal staining
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opti-Free RepleniSHDevice
Commercially available contact lens solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.
ReNu MultiPlusDevice
Also called Renu
Commercially available contact lens solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.
Balafilcon ADevice
Also called PureVision
Commercially available silicone hydrogel contact lenses removed from blister pack and soaked overnight in Opti-Free Replenish, ReNu MultiPlus, or Unisol 4, then applied to the eye and worn for 2 hours.
Unisol 4Other
Commercially available non preserved sterile saline solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.
| Study group | Role | What they receive |
|---|---|---|
| Contact lens wearers | Experimental | Contact lens wearers experienced three currently available contact lens/contact lens care combinations in randomized order: balafilcon A + Optifree RepleniSH, balafilcon A + ReNu MultiPlus, and balafilcon A + Unisol 4 saline. Receives: Device: Opti-Free RepleniSH; Device: ReNu MultiPlus; Device: Balafilcon A; Other: Unisol 4 |
| Non-lens wearers | No intervention | Non-lens wearers completed one study visit and served as the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear Protein Expression
Measured: 1 day
Secondary outcomes (1)
Corneal Staining
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal StainingStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jami Kern, Study director, Alcon, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100424
- Sponsor's protocol ID
- SMA-09-20
- Status last verified
- Jul 2012
- First submitted
- 7 Apr 2010
- Last updated
- 23 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Tear Film-Based Proteins Associated With Care Solution Induced Corneal Staining
- ClinicalTrials.gov ID
- NCT01100424
- Acronym / sponsor ID
- SMA-09-20
- Conditions
- Corneal Staining
- Keywords
- Contact lenses, Contact lens solution, Corneal staining
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 9 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 purpose of this study was to investigate the association of inflammatory mediators found in the tear film during the development and following the induction of contact lens solution-induced corneal staining.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contact lens wearers | Experimental | Device: Opti-Free RepleniSH, Device: ReNu MultiPlus, Device: Balafilcon A, Other: Unisol 4Contact lens wearers experienced three currently available contact lens/contact lens care combinations in randomized order: balafilcon A + Optifree RepleniSH, balafilcon A + ReNu MultiPlus, and balafilcon A + Unisol 4 saline. |
| Non-lens wearers | No intervention | –Non-lens wearers completed one study visit and served as the control group. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Normal eyes.
- Currently not wearing contact lenses and has not worn contact lenses for the previous 6 months.
- Free of dry eye using the Ocular Surface Disease Index (Schiffman et al).
- Other protocol-defined inclusion criteria may apply.
- Currently wearing soft contact lenses.
Key exclusion criteria (5 listed)
- Pregnant.
- Participating in another research study.
- Exhibiting staining with fluorescein in more than 5% of the total cornea (graded by "extent" of staining across 5 regions).
- Other protocol-defined exclusion criteria may apply.
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 |
|---|---|---|
| Opti-Free RepleniSHCommercially available contact lens solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion. | Device | Contact lens wearers |
| ReNu MultiPlusAlso: RenuCommercially available contact lens solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion. | Device | Contact lens wearers |
| Balafilcon AAlso: PureVisionCommercially available silicone hydrogel contact lenses removed from blister pack and soaked overnight in Opti-Free Replenish, ReNu MultiPlus, or Unisol 4, then applied to the eye and worn for 2 hours. | Device | Contact lens wearers |
| Unisol 4Commercially available non preserved sterile saline solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion. | Other | Contact lens wearers |
Primary outcome
Tear Protein Expression
Time frame: 1 day
1 secondary outcome
Corneal Staining
Time frame: 1 day
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 23 Oct 2012.
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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.
Jami Kern study director
Alcon, Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opti-Free RepleniSH, ReNu MultiPlus and Balafilcon A in people with Corneal Staining, run by Alcon Research 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 11 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: finished, as of the sponsor's last update on 23 Oct 2012. 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?
Tear Protein Expression (time frame: 1 day). 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 23 Oct 2012.