Normal Contact Lens WearNCT00804999
Two Phase Clinical Study of the Impact of Contact Lenses and Solutions on Corneal Structure
A study testing Clear Care, ReNu and OPTI-FREE in people with Normal Contact Lens Wear, run by Christine Sindt at 1 site in United States.
Trial summary
Assess the usefulness of using confocal microscopy to examine changes to the structure of the cornea and to identify any potential consequences of contact lens wear and/or solution use. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Normal Contact Lens Wear
- What is being tested?
- Clear Care, ReNu and OPTI-FREE
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2008to 1 Mar 2009
- 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
- Vision correctable to 20/30 or better in both eyes
- Successful soft contact lens wear for at least 2 weeks prior to enrollment
Who cannot join
- History of hypersensitivity to any of the components in any of the lens solutions
- One functional eye or a monofit lens
- Any abnormal slit-lamp finding at baseline
- Use of topical ocular meds
- Any systemic condition with significant ocular side effects or that interfere with contact lens wear
- Enrollment of the investigator's office staff, relatives or members of their respective households
- Enrollment of more than one member of the same household
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Contact Lens Clinic
Iowa City, Iowa, 52242
About this study
Assess the usefulness of using confocal microscopy to examine changes to the structure of the cornea and to identify any potential consequences of contact lens wear and/or solution use.
Read the detailed description
Several types of solutions are used in contact lens wear.
Each contact lens solution used to disinfect contacts have different ingredients even though they all disinfect the contacts.
The objective of this study is to examine the layers of the cornea via HRT in order to assess the usefulness of this technology and to identify any potential consequences of contact lens wear and/or care solution used.
- Conditions
- Normal Contact Lens Wear
- Being tested
- Clear Care, ReNu, OPTI-FREE
- Keywords
- confocal microscopy, contact lens wear, contact lens solutions, sodium fluorescein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clear CareDrug
Also called hydrogen peroxide disinfecting solution
neutralized Clear Care
ReNuDrug
overnight soak in solution
OPTI-FREEDrug
Also called Replenish
overnight soak in solution
| Study group | Role | What they receive |
|---|---|---|
| Placebo 1 | Placebo comparator | Subjects that have never worn contacts with no ocular problems were selected. A baseline HRT was performed. Trial contact lenses were soaked in clear care solution for 10 hours. After 10 hours of the lenses soaking in clear care the subject returned. The contacts lenses that were soaked in clear care were inserted onto the patients eyes. The patient then wore the contacts for two hours. After two hours the contact lenses were removed. An HRT was performed immediately after removing the contact lenses. The HRT scans were analyzed for dendritic cell migration, basal cell epithelial density and nerve density and tortuosity. Receives: Drug: Clear Care |
| Renu | Active comparator | Subjects that had worn contacts for at least two weeks without incident were selected. A baseline HRT was performed.Trial contacts lenses were soaked in ReNu contact solution for 10 hours. After 10 hours of the lenses soaking in ReNu the subject returned. The contacts were inserted onto the patients eyes. The patient then wore the contacts for two hours. After two hours the contacts lenses were removed. An HRT both with and without sodium fluorescein was performed immediately after removing the contact lenses.The HRT scans were analyzed for dendritic cell migration, basal cell epithelial density and nerve density and tortuosity. Receives: Drug: ReNu |
| Optifree | Active comparator | Subjects that had worn contacts for at least two weeks without incident were selected. A baseline HRT was performed.Trial contacts lenses were soaked in Optifree Replenish contact solution for 10 hours. After 10 hours of the lenses soaking in Optifree Replenish the subject returned. The contacts were inserted onto the patients eyes. The patient wore contacts the for two hours. After two hours the contacts were removed. An HRT both with and without sodium fluorescein was performed immediately after removing the contact lenses.The HRT scans were analyzed for dendritic cell migration, basal cell epithelial density and nerve density and tortuosity. Receives: Drug: OPTI-FREE |
What is being measured
The primary outcome is the main question the study is designed to answer.
HRT Corneal Scan
Looking for cell density
Measured: baseline and 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study start1 Nov 2008
- Primary completion1 Mar 2009
- Study completion1 Mar 2009
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.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Normal Contact Lens WearStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christine Sindt
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor-investigator, Christine Sindt, University of Iowa
- Investigators
- Christine W Sindt, O.D., Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804999
- Sponsor's protocol ID
- 200806729
- Status last verified
- Dec 2017
- First submitted
- 5 Dec 2008
- Last updated
- 23 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to share IPD.
Publications
Patel DV, McGhee CN. In vivo laser scanning confocal microscopy confirms that the human corneal sub-basal nerve plexus is a highly dynamic structure. Invest Ophthalmol Vis Sci. 2008 Aug;49(8):3409-12. doi: 10.1167/iovs.08-1951. Epub 2008 Apr 25.
PubMed 18441297Dosso AA, Rungger-Brandle E. Clinical course of epidemic keratoconjunctivitis: evaluation by in vivo confocal microscopy. Cornea. 2008 Apr;27(3):263-8. doi: 10.1097/ICO.0b013e31815b7d7d.
PubMed 18362649Fonn D, Simpson T, Woods J, Woods C. New technologies to assess lens-mediated effects of the cornea. Eye Contact Lens. 2007 Nov;33(6 Pt 2):364-70; discussion 382. doi: 10.1097/ICL.0b013e318157c98f.
PubMed 17975422Bantseev V, McCanna DJ, Driot JY, Ward KW, Sivak JG. Biocompatibility of contact lens solutions using confocal laser scanning microscopy and the in vitro bovine cornea. Eye Contact Lens. 2007 Nov;33(6 Pt 1):308-16. doi: 10.1097/ICL.0b013e31803c55ad.
PubMed 17993827Kanavi MR, Javadi M, Yazdani S, Mirdehghanm S. Sensitivity and specificity of confocal scan in the diagnosis of infectious keratitis. Cornea. 2007 Aug;26(7):782-6. doi: 10.1097/ICO.0b013e318064582d.
PubMed 17667609Efron N. Contact lens-induced changes in the anterior eye as observed in vivo with the confocal microscope. Prog Retin Eye Res. 2007 Jul;26(4):398-436. doi: 10.1016/j.preteyeres.2007.03.003. Epub 2007 Apr 1.
PubMed 17498998Zhivov A, Stave J, Vollmar B, Guthoff R. In vivo confocal microscopic evaluation of langerhans cell density and distribution in the corneal epithelium of healthy volunteers and contact lens wearers. Cornea. 2007 Jan;26(1):47-54. doi: 10.1097/ICO.0b013e31802e3b55.
PubMed 17198013Bastion ML, Mohamad MH. Study of the factors associated with the presence of white dots in the corneas of regular soft contact lens users from an Asian country. Eye Contact Lens. 2006 Sep;32(5):223-7. doi: 10.1097/01.icl.0000199891.35160.68.
PubMed 16974154Su PY, Hu FR, Chen YM, Han JH, Chen WL. Dendritiform cells found in central cornea by in-vivo confocal microscopy in a patient with mixed bacterial keratitis. Ocul Immunol Inflamm. 2006 Aug;14(4):241-4. doi: 10.1080/09273940600732398.
PubMed 16911987Nguyen TH, Dudek LT, Krisciunas TC, Matiaco P, Planck SR, Mathers WD, Rosenbaum JT. In vivo confocal microscopy: increased conjunctival or episcleral leukocyte adhesion in patients who wear contact lenses with lower oxygen permeability (Dk) values. Cornea. 2004 Oct;23(7):695-700. doi: 10.1097/01.ico.0000127482.00843.c8.
PubMed 15448495Patel SV, McLaren JW, Hodge DO, Bourne WM. Confocal microscopy in vivo in corneas of long-term contact lens wearers. Invest Ophthalmol Vis Sci. 2002 Apr;43(4):995-1003.
PubMed 11923239
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Phase Clinical Study of the Impact of Contact Lenses and Solutions on Corneal Structure
- ClinicalTrials.gov ID
- NCT00804999
- Acronym / sponsor ID
- 200806729
- Conditions
- Normal Contact Lens Wear
- Keywords
- confocal microscopy, contact lens wear, contact lens solutions, sodium fluorescein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Christine SindtUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 1 Nov 2008 (actual)
- Primary completion
- 1 Mar 2009 (actual)
- Study completion
- 1 Mar 2009 (actual)
- First posted
- 9 Dec 2008 (estimated)
- Results
- Posted 23 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess the usefulness of using confocal microscopy to examine changes to the structure of the cornea and to identify any potential consequences of contact lens wear and/or solution use.
Detailed description
Several types of solutions are used in contact lens wear.
Each contact lens solution used to disinfect contacts have different ingredients even though they all disinfect the contacts.
The objective of this study is to examine the layers of the cornea via HRT in order to assess the usefulness of this technology and to identify any potential consequences of contact lens wear and/or care solution used.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo 1 | Placebo comparator | Drug: Clear CareSubjects that have never worn contacts with no ocular problems were selected. A baseline HRT was performed. Trial contact lenses were soaked in clear care solution for 10 hours. After 10 hours of the lenses soaking in clear care the subject returned. The contacts lenses that were soaked in clear care were inserted onto the patients eyes. The patient then wore the contacts for two hours. After two hours the contact lenses were removed. An HRT was performed immediately after removing the contact lenses. The HRT scans were analyzed for dendritic cell migration, basal cell epithelial density and nerve density and tortuosity. |
| Renu | Active comparator | Drug: ReNuSubjects that had worn contacts for at least two weeks without incident were selected. A baseline HRT was performed.Trial contacts lenses were soaked in ReNu contact solution for 10 hours. After 10 hours of the lenses soaking in ReNu the subject returned. The contacts were inserted onto the patients eyes. The patient then wore the contacts for two hours. After two hours the contacts lenses were removed. An HRT both with and without sodium fluorescein was performed immediately after removing the contact lenses.The HRT scans were analyzed for dendritic cell migration, basal cell epithelial density and nerve density and tortuosity. |
| Optifree | Active comparator | Drug: OPTI-FREESubjects that had worn contacts for at least two weeks without incident were selected. A baseline HRT was performed.Trial contacts lenses were soaked in Optifree Replenish contact solution for 10 hours. After 10 hours of the lenses soaking in Optifree Replenish the subject returned. The contacts were inserted onto the patients eyes. The patient wore contacts the for two hours. After two hours the contacts were removed. An HRT both with and without sodium fluorescein was performed immediately after removing the contact lenses.The HRT scans were analyzed for dendritic cell migration, basal cell epithelial density and nerve density and tortuosity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Vision correctable to 20/30 or better in both eyes
- Successful soft contact lens wear for at least 2 weeks prior to enrollment
Key exclusion criteria (7 listed)
- History of hypersensitivity to any of the components in any of the lens solutions
- One functional eye or a monofit lens
- Any abnormal slit-lamp finding at baseline
- Use of topical ocular meds
- Any systemic condition with significant ocular side effects or that interfere with 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 |
|---|---|---|
| Clear CareAlso: hydrogen peroxide disinfecting solutionneutralized Clear Care | Drug | Placebo 1 |
| ReNuovernight soak in solution | Drug | Renu |
| OPTI-FREEAlso: Replenishovernight soak in solution | Drug | Optifree |
Primary outcome
HRT Corneal Scan
Time frame: baseline and 2 hours
Looking for cell density
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18441297Patel DV, McGhee CN. In vivo laser scanning confocal microscopy confirms that the human corneal sub-basal nerve plexus is a highly dynamic structure. Invest Ophthalmol Vis Sci. 2008 Aug;49(8):3409-12. doi: 10.1167/iovs.08-1951. Epub 2008 Apr 25.
- Background: PubMed 18362649Dosso AA, Rungger-Brandle E. Clinical course of epidemic keratoconjunctivitis: evaluation by in vivo confocal microscopy. Cornea. 2008 Apr;27(3):263-8. doi: 10.1097/ICO.0b013e31815b7d7d.
- Background: PubMed 17975422Fonn D, Simpson T, Woods J, Woods C. New technologies to assess lens-mediated effects of the cornea. Eye Contact Lens. 2007 Nov;33(6 Pt 2):364-70; discussion 382. doi: 10.1097/ICL.0b013e318157c98f.
- Background: PubMed 17993827Bantseev V, McCanna DJ, Driot JY, Ward KW, Sivak JG. Biocompatibility of contact lens solutions using confocal laser scanning microscopy and the in vitro bovine cornea. Eye Contact Lens. 2007 Nov;33(6 Pt 1):308-16. doi: 10.1097/ICL.0b013e31803c55ad.
- Background: PubMed 17667609Kanavi MR, Javadi M, Yazdani S, Mirdehghanm S. Sensitivity and specificity of confocal scan in the diagnosis of infectious keratitis. Cornea. 2007 Aug;26(7):782-6. doi: 10.1097/ICO.0b013e318064582d.
- Background: PubMed 17498998Efron N. Contact lens-induced changes in the anterior eye as observed in vivo with the confocal microscope. Prog Retin Eye Res. 2007 Jul;26(4):398-436. doi: 10.1016/j.preteyeres.2007.03.003. Epub 2007 Apr 1.
- Background: PubMed 17198013Zhivov A, Stave J, Vollmar B, Guthoff R. In vivo confocal microscopic evaluation of langerhans cell density and distribution in the corneal epithelium of healthy volunteers and contact lens wearers. Cornea. 2007 Jan;26(1):47-54. doi: 10.1097/ICO.0b013e31802e3b55.
- Background: PubMed 16974154Bastion ML, Mohamad MH. Study of the factors associated with the presence of white dots in the corneas of regular soft contact lens users from an Asian country. Eye Contact Lens. 2006 Sep;32(5):223-7. doi: 10.1097/01.icl.0000199891.35160.68.
- Background: PubMed 16911987Su PY, Hu FR, Chen YM, Han JH, Chen WL. Dendritiform cells found in central cornea by in-vivo confocal microscopy in a patient with mixed bacterial keratitis. Ocul Immunol Inflamm. 2006 Aug;14(4):241-4. doi: 10.1080/09273940600732398.
- Background: PubMed 15448495Nguyen TH, Dudek LT, Krisciunas TC, Matiaco P, Planck SR, Mathers WD, Rosenbaum JT. In vivo confocal microscopy: increased conjunctival or episcleral leukocyte adhesion in patients who wear contact lenses with lower oxygen permeability (Dk) values. Cornea. 2004 Oct;23(7):695-700. doi: 10.1097/01.ico.0000127482.00843.c8.
- Background: PubMed 11923239Patel SV, McLaren JW, Hodge DO, Bourne WM. Confocal microscopy in vivo in corneas of long-term contact lens wearers. Invest Ophthalmol Vis Sci. 2002 Apr;43(4):995-1003.
- Individual participant dataSharing planned: No. There is no plan to share IPD.
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.
Christine W Sindt, O.D. principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clear Care, ReNu and OPTI-FREE in people with Normal Contact Lens Wear, run by Christine Sindt 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 7 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 Jan 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?
Yes. Results are posted in the registry (first posted 23 Jan 2018). 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?
HRT Corneal Scan (time frame: baseline and 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00804999, which also lists 11 linked publications.
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 Jan 2018.