Corneal StainingNCT01335750
A Clinical Comparison of Marketed Lens Care Solutions With Avaira Lens Brand
A study testing Multipurpose Solution #1, Multipurpose Solution #2 and Mutlipurpose Solution #3 in people with Corneal Staining, run by CooperVision, Inc. at 1 site in United States.
Trial summary
This study is a clinical comparison of the biocompatibility of several multipurpose solutions, Renu Fresh, Optifree Replenish, and ClearCare, and saline as a control solution among adapted hydrogel contact lens wearers wearing Avaira (enfilcon A) contact lenses at one research site. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Corneal Staining
- What is being tested?
- Multipurpose Solution #1, Multipurpose Solution #2 and Mutlipurpose Solution #3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Sep 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Informed Consent and HIPAA document read, signed, and dated.
- Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with hydrogel or silicone hydrogel contact lenses.
- Successfully wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis for at least two weeks prior to the study.
Who cannot join
- History of hypersensitivity
- Evidence or history of epithelial herpes simplex keratitis (dendritic keratitis; vaccinia, active or recent varicella, viral disease of the cornea and/or conjunctiva and/or eyelids; bacterial infection of the eye; and/or fungal disease of the eye
- One functional eye or a monofit eye
- Ocular conditions such as active acute blepharitis, conjunctival infections, and iritis
- Type 2 (macropunctate) or greater corneal staining in any region in either eye as observed by slit-lamp at Visit 1 of each study period
- Sum of the type of corneal staining greater than or equal to 4 across entire cornea in either eye as observed by slit-lamp at Visit 1 of each study period
Show all 12Show fewer
- Conjunctival staining covering greater than or equal to 20% in 2 or more corneal regions in either eye as observed by slit-lamp at Visit 1 of each study period
- Conjunctival injection greater than Grade 2 (moderate-diffuse redness) in either eye as observed by slit-lamp at Visit 1 of each study period
- Abnormal lenticular opacity in the visual axis of the lens in either eye
- Use of concomitant topical Rx or over-the-counter (OTC) ocular medications
- History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear
- Pregnant or lactating females
Trial locations and contacts
1 site in 1 country.
About this study
This study is a clinical comparison of the biocompatibility of several multipurpose solutions, Renu Fresh, Optifree Replenish, and ClearCare, and saline as a control solution among adapted hydrogel contact lens wearers wearing Avaira (enfilcon A) contact lenses at one research site.
- Conditions
- Corneal Staining
- Being tested
- Multipurpose Solution #1, Multipurpose Solution #2, Mutlipurpose Solution #3, Multipurpose Solution #4
- Keywords
- corneal staining
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multipurpose Solution #1Other
B\&L Renu Fresh Multipurpose Solution
Multipurpose Solution #2Other
Optifree Replenish Multipurpose Solution
Mutlipurpose Solution #3Other
Ciba ClearCare Multipurpose Solution
Multipurpose Solution #4Other
Saline Solution
| Study group | Role | What they receive |
|---|---|---|
| Multipurpose Solution #1 | Experimental | B\&L Renu Fresh Multipurpose Solution Receives: Other: Multipurpose Solution #1; Other: Multipurpose Solution #2; Other: Mutlipurpose Solution #3; Other: Multipurpose Solution #4 |
| Multipurpose Solution #2 | Experimental | OptiFree Replenish Multipurpose Solution Receives: Other: Multipurpose Solution #1; Other: Multipurpose Solution #2; Other: Mutlipurpose Solution #3; Other: Multipurpose Solution #4 |
| Multipurpose Solution #3 | Experimental | Ciba ClearCare Multipurpose Solution Receives: Other: Multipurpose Solution #1; Other: Multipurpose Solution #2; Other: Mutlipurpose Solution #3; Other: Multipurpose Solution #4 |
| Multipurpose Solution #4 | Active comparator | Saline Solution Receives: Other: Multipurpose Solution #1; Other: Multipurpose Solution #2; Other: Mutlipurpose Solution #3; Other: Multipurpose Solution #4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Staining Severity
Severity of staining was recorded for each region using a scale of 0-none to 4-patch >/=1mm. Analysis of staining was performed by averaging the scores from the five regions for each eye, then identifying the subject's worse eye at each visit. Mean total severity was calcuated from all identified eyes for each visit.
Measured: Baseline, 2 Hour Period, 4 Hour Period
Corneal Staining Area
Analysis of staining area was performed by averaging the values from the five regions for each eye and then identifying the subject's worse eye at each visit. Mean total area was calculated from all identified eyes for each visit.
Measured: Baseline, 2 Hour Period, 4 Hour Period
Secondary outcomes (2)
Subjective Comfort
Subjective comfort ratings 0-100 (0=causes pain, 100=excellent comfort)
Measured: Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours
Subjective Dryness
Subjective dryness ratings 0-100 (0=extremely dry, 100=extremely moist)
Measured: Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startAug 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.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Corneal StainingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary Andrasko, OD, MS, Principal investigator, Erdey/Searcy Eye Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335750
- Sponsor's protocol ID
- CV-09-64, Sterling IRB 3576
- Status last verified
- Jul 2020
- First submitted
- 7 Oct 2010
- Last updated
- 28 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Comparison of Marketed Lens Care Solutions With Avaira Lens Brand
- ClinicalTrials.gov ID
- NCT01335750
- Acronym / sponsor ID
- CV-09-64, Sterling IRB 3576
- Conditions
- Corneal Staining
- Keywords
- corneal staining
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 14 Apr 2011 (estimated)
- Results
- Posted 5 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a clinical comparison of the biocompatibility of several multipurpose solutions, Renu Fresh, Optifree Replenish, and ClearCare, and saline as a control solution among adapted hydrogel contact lens wearers wearing Avaira (enfilcon A) contact lenses at one research site.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Multipurpose Solution #1 | Experimental | Other: Multipurpose Solution #1, Other: Multipurpose Solution #2, Other: Mutlipurpose Solution #3, Other: Multipurpose Solution #4B\&L Renu Fresh Multipurpose Solution |
| Multipurpose Solution #2 | Experimental | Other: Multipurpose Solution #1, Other: Multipurpose Solution #2, Other: Mutlipurpose Solution #3, Other: Multipurpose Solution #4OptiFree Replenish Multipurpose Solution |
| Multipurpose Solution #3 | Experimental | Other: Multipurpose Solution #1, Other: Multipurpose Solution #2, Other: Mutlipurpose Solution #3, Other: Multipurpose Solution #4Ciba ClearCare Multipurpose Solution |
| Multipurpose Solution #4 | Active comparator | Other: Multipurpose Solution #1, Other: Multipurpose Solution #2, Other: Mutlipurpose Solution #3, Other: Multipurpose Solution #4Saline Solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed Consent and HIPAA document read, signed, and dated.
- Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with hydrogel or silicone hydrogel contact lenses.
- Successfully wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis for at least two weeks prior to the study.
Key exclusion criteria (12 listed)
- History of hypersensitivity
- Evidence or history of epithelial herpes simplex keratitis (dendritic keratitis; vaccinia, active or recent varicella, viral disease of the cornea and/or conjunctiva and/or eyelids; bacterial infection of the eye; and/or fungal disease of the eye
- One functional eye or a monofit eye
- Ocular conditions such as active acute blepharitis, conjunctival infections, and iritis
- Type 2 (macropunctate) or greater corneal staining in any region in either eye as observed by slit-lamp at Visit 1 of each study period
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 |
|---|---|---|
| Multipurpose Solution #1B\&L Renu Fresh Multipurpose Solution | Other | Multipurpose Solution #1, Multipurpose Solution #2, Multipurpose Solution #3, Multipurpose Solution #4 |
| Multipurpose Solution #2Optifree Replenish Multipurpose Solution | Other | Multipurpose Solution #1, Multipurpose Solution #2, Multipurpose Solution #3, Multipurpose Solution #4 |
| Mutlipurpose Solution #3Ciba ClearCare Multipurpose Solution | Other | Multipurpose Solution #1, Multipurpose Solution #2, Multipurpose Solution #3, Multipurpose Solution #4 |
| Multipurpose Solution #4Saline Solution | Other | Multipurpose Solution #1, Multipurpose Solution #2, Multipurpose Solution #3, Multipurpose Solution #4 |
Primary outcome
Corneal Staining Severity
Time frame: Baseline, 2 Hour Period, 4 Hour Period
Severity of staining was recorded for each region using a scale of 0-none to 4-patch >/=1mm. Analysis of staining was performed by averaging the scores from the five regions for each eye, then identifying the subject's worse eye at each visit. Mean total severity was calcuated from all identified eyes for each visit.
Corneal Staining Area
Time frame: Baseline, 2 Hour Period, 4 Hour Period
Analysis of staining area was performed by averaging the values from the five regions for each eye and then identifying the subject's worse eye at each visit. Mean total area was calculated from all identified eyes for each visit.
2 secondary outcomes
Subjective Comfort
Time frame: Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours
Subjective Dryness
Time frame: Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here for more information about similar studiesLink provided by the sponsor.
Related trials for Corneal Staining
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Efficacy of 0.28% Sodium Hyaluronate Eye Drops in Patient With Moderate to Severe Dry Eye
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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.
Gary Andrasko, OD, MS principal investigator
Erdey/Searcy Eye Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multipurpose Solution #1, Multipurpose Solution #2 and Mutlipurpose Solution #3 in people with Corneal Staining, run by CooperVision, Inc. 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 3 inclusion and 12 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 28 Jul 2020. 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?
Yes. Results are posted in the registry (first posted 5 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Corneal Staining Severity (time frame: Baseline, 2 Hour Period, 4 Hour Period). The study lists 2 primary outcomes in all. 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 28 Jul 2020; AzTrials last refreshed its copy on 8 Nov 2026.