MyopiaPhase 4NCT01250925
Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface
A Phase 4 study testing ReNu MultiPlus® MultiPurpose Solution, OPTI-FREE® RepleniSH® and Clear Care® in people with Myopia and Refractive Error, run by Massachusetts Eye and Ear Infirmary at 2 sites in United States.
Trial summary
The purpose of this study is to utilize in-vivo confocal microscopy to describe differences in corneal epithelial immune status across three lens care regimens in new contact lens wearers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia, Refractive Error
- What is being tested?
- ReNu MultiPlus® MultiPurpose Solution, OPTI-FREE® RepleniSH® and Clear Care®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2010to Jul 2012
- Phase
- Phase 4
- 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
- Subjects must be 18 years of age and may be of any race and either gender.
- Subjects must not have ever worn contact lenses.
- Subjects must have normal, healthy eyes.
Who cannot join
- Subjects must not use additional lens cleaners.
- subjects must not have any ocular or systemic disease.
- Subjects must not have history of ocular surgery/trauma within the last 6 months.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
University of Iowa
Iowa City, Iowa, 52242-1091
About this study
Official title: Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface: A Laser In Vivo Confocal Microscopy Study
The purpose of this study is to utilize in-vivo confocal microscopy to describe differences in corneal epithelial immune status across three lens care regimens in new contact lens wearers.
Read the detailed description
An estimated 40 million people in the United States wear contact lenses, with approximately 38 million soft lens wearers and 2 million rigid gas permeable lens wearers. The ocular surface has been shown to respond to the introduction of foreign materials with upregulation of proinflammatory mediators, leading to an increase in inflammation. The corneal can show a foreign body immune response to contact lenses. The purpose of this study is to utilize in-vivo confocal microscopy to describe differences in corneal epithelial immune status across the three lens care regimens in new contact lens wearers.
- Conditions
- Myopia, Refractive Error
- Being tested
- ReNu MultiPlus® MultiPurpose Solution, OPTI-FREE® RepleniSH®, Clear Care®
- Keywords
- Contact lens, Lens care
- Medical subject headings
- Myopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReNu MultiPlus® MultiPurpose SolutionDrug
Contact lens care regimen
OPTI-FREE® RepleniSH®Drug
Contact Lens care regimen
Clear Care®Drug
Contact lens care regimen
| Study group | Role | What they receive |
|---|---|---|
| OPTI-FREE® RepleniSH® | Active comparator | 33 participants will be assigned to use this lens care regimen during the six-week assessment period Receives: Drug: OPTI-FREE® RepleniSH® |
| Clear Care® | Active comparator | 33 participants will be assigned to use this lens care regimen during the six-week assessment period Receives: Drug: Clear Care® |
| ReNu MultiPlus® MultiPurpose Solution | Active comparator | 33 participants will be assigned to use this lens care regimen during the six-week assessment period Receives: Drug: ReNu MultiPlus® MultiPurpose Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Epithelial Immune Dendritic Cell Density (Central Cornea)
The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Measured: Six weeks
Corneal Epithelial Immune Dendritic Cell Density (Inferior Cornea)
The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Measured: Six weeks
Corneal Epithelial Immune Dendritic Cell Density (Nasal Cornea)
The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Measured: Six weeks
Corneal Epithelial Immune Dendritic Cell Density (Superior Cornea)
The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Measured: Six weeks
Corneal Epithelial Immune Dendritic Cell Density (Temporal Cornea)
The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Measured: Six weeks
Corneal Epithelial Immune Non-Dendritic Cell Density (Central Cornea)
The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Measured: Six weeks
Corneal Epithelial Immune Non-Dendritic Cell Density (Inferior Cornea)
The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Measured: Six weeks
Corneal Epithelial Immune Non-Dendritic Cell Density (Nasal Cornea)
The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Measured: Six weeks
Corneal Epithelial Immune Non-Dendritic Cell Density (Superior Cornea)
The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Measured: Six weeks
Corneal Epithelial Immune Non-Dendritic Cell Density (Temporal Cornea)
The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Measured: Six weeks
Secondary outcomes (1)
Number of Participants With Slit-lamp Findings, Corrected Visual Acuity (Snellen) and Adverse Events
The safety analysis will be based on slit-lamp findings, corrected visual acuity (Snellen) and adverse events (if any). No inferential statistical analyses are planned for any safety variable.
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startAug 2010
- Primary completionFeb 2012
- Study completionJul 2012
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 MyopiaStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iowa, Alcon Research
- Responsible party
- Sponsor
- Investigators
- Pedram Hamrah, MD, Principal investigator, Massachusetts Eye and Ear InfirmaryChristine Sindt, OD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250925
- Sponsor's protocol ID
- 10-04-029
- Status last verified
- Apr 2013
- First submitted
- 29 Nov 2010
- Last updated
- 10 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface: A Laser In Vivo Confocal Microscopy Study
- ClinicalTrials.gov ID
- NCT01250925
- Acronym / sponsor ID
- 10-04-029
- Conditions
- Myopia, Refractive Error
- Keywords
- Contact lens, Lens care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Collaborators
- University of Iowa, Alcon Research
- Study start
- Aug 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 1 Dec 2010 (estimated)
- Results
- Posted 10 Jan 2017
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 utilize in-vivo confocal microscopy to describe differences in corneal epithelial immune status across three lens care regimens in new contact lens wearers.
Detailed description
An estimated 40 million people in the United States wear contact lenses, with approximately 38 million soft lens wearers and 2 million rigid gas permeable lens wearers. The ocular surface has been shown to respond to the introduction of foreign materials with upregulation of proinflammatory mediators, leading to an increase in inflammation. The corneal can show a foreign body immune response to contact lenses. The purpose of this study is to utilize in-vivo confocal microscopy to describe differences in corneal epithelial immune status across the three lens care regimens in new contact lens wearers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OPTI-FREE® RepleniSH® | Active comparator | Drug: OPTI-FREE® RepleniSH®33 participants will be assigned to use this lens care regimen during the six-week assessment period |
| Clear Care® | Active comparator | Drug: Clear Care®33 participants will be assigned to use this lens care regimen during the six-week assessment period |
| ReNu MultiPlus® MultiPurpose Solution | Active comparator | Drug: ReNu MultiPlus® MultiPurpose Solution33 participants will be assigned to use this lens care regimen during the six-week assessment period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must be 18 years of age and may be of any race and either gender.
- Subjects must not have ever worn contact lenses.
- Subjects must have normal, healthy eyes.
Key exclusion criteria (3 listed)
- Subjects must not use additional lens cleaners.
- subjects must not have any ocular or systemic disease.
- Subjects must not have history of ocular surgery/trauma within the last 6 months.
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 |
|---|---|---|
| ReNu MultiPlus® MultiPurpose SolutionContact lens care regimen | Drug | ReNu MultiPlus® MultiPurpose Solution |
| OPTI-FREE® RepleniSH®Contact Lens care regimen | Drug | OPTI-FREE® RepleniSH® |
| Clear Care®Contact lens care regimen | Drug | Clear Care® |
Primary outcome
Corneal Epithelial Immune Dendritic Cell Density (Central Cornea)
Time frame: Six weeks
The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Corneal Epithelial Immune Dendritic Cell Density (Inferior Cornea)
Time frame: Six weeks
The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Corneal Epithelial Immune Dendritic Cell Density (Nasal Cornea)
Time frame: Six weeks
The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Corneal Epithelial Immune Dendritic Cell Density (Superior Cornea)
Time frame: Six weeks
The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Corneal Epithelial Immune Dendritic Cell Density (Temporal Cornea)
Time frame: Six weeks
The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Corneal Epithelial Immune Non-Dendritic Cell Density (Central Cornea)
Time frame: Six weeks
The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Corneal Epithelial Immune Non-Dendritic Cell Density (Inferior Cornea)
Time frame: Six weeks
The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Corneal Epithelial Immune Non-Dendritic Cell Density (Nasal Cornea)
Time frame: Six weeks
The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Corneal Epithelial Immune Non-Dendritic Cell Density (Superior Cornea)
Time frame: Six weeks
The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Corneal Epithelial Immune Non-Dendritic Cell Density (Temporal Cornea)
Time frame: Six weeks
The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
1 secondary outcome
Number of Participants With Slit-lamp Findings, Corrected Visual Acuity (Snellen) and Adverse Events
Time frame: Six weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Pedram Hamrah, MD principal investigator
Massachusetts Eye and Ear Infirmary
Christine Sindt, OD principal investigator
University of Iowa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ReNu MultiPlus® MultiPurpose Solution, OPTI-FREE® RepleniSH® and Clear Care® in people with Myopia and Refractive Error, run by Massachusetts Eye and Ear Infirmary at 2 sites 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 3 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 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jan 2017). 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 Epithelial Immune Dendritic Cell Density (Central Cornea) (time frame: Six weeks). The study lists 10 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 10 Jan 2017.