Contact Lens SolutionsNCT00789529
Objective Testing of Tear Film Stability
A study testing Opti-Free® RepleniSH® MPDS and ReNu MultiPlus® in people with Contact Lens Solutions, run by Manhattan Vision Associates at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the in-vivo wettability of soft contact lenses when cared with two different multi-purpose solutions over a two week wearing period. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Contact Lens Solutions
- What is being tested?
- Opti-Free® RepleniSH® MPDS and ReNu MultiPlus®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Nov 2008
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject must be at least 18 years of age and no more than 80 years of age.
- The subject must have a best corrected visual acuity of 20/30 or better for each eye.
- The subject must habitually wear contact lenses.
- The subject must have had an eye exam within the last 12 months. The exam data must be available to the investigators prior to the first visit.
- The subject must have normal eyes, no use of ocular medications, no ocular infection of any type, and no ocular inflammation.
- The subject must read understand and sign the Statement of Informed Consent.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Who cannot join
- Ocular or systemic allergies or disease that might interfere with contact lens wear.
- Systemic disease, autoimmune disease or use of medication which might interfere with contact lens wear.
- Clinically significant (FDA Scale grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormalities of the cornea which would contraindicate contact lens wear.
- Clinically significant (FDA Scale grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
- Any ocular infection.
- Pregnancy or lactation.
Show all 9Show fewer
- Diabetes
- Infectious diseases (e.g. hepatitis, tuberculosis)
- Contagious immunosuppressive diseases (e.g. HIV)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the in-vivo wettability of soft contact lenses when cared with two different multi-purpose solutions over a two week wearing period.
- Conditions
- Contact Lens Solutions
- Being tested
- Opti-Free® RepleniSH® MPDS, ReNu MultiPlus®
- Keywords
- Contact lenses, wettability, Contact Lens Disinfectant Solutions, pre-lens tear film
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opti-Free® RepleniSH® MPDSDevice
soft contact lens disinfecting solution
ReNu MultiPlus®Device
soft contact lens disinfecting solution
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Opti-Free® RepleniSH® MPDS Receives: Device: Opti-Free® RepleniSH® MPDS |
| 2 | Active comparator | Renu MultiPlus® Receives: Device: ReNu MultiPlus® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective, In-vivo Soft Contact Lens Wettability Index
The wettability index is derived from the slope of a metric developed to measure the regularity of the Shack-Hartmann wavefront sensor image. The more wettable a lens is the more stable the metric and the slope of the metric (the wettability index) is closer to zero. The more negative values indicate a less wettable the lens.
Measured: 2 weeks
Secondary outcomes (1)
Subject Questionnaire Response
Subject questionnaire response: Overall comfort at 2 weeks in a 0-50 point scale.
0=Very poor 50 = Excellent
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startSep 2008
- Primary completionNov 2008
- Study completionNov 2008
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 Contact Lens SolutionsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manhattan Vision Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
- Investigators
- George Zikos, OS, MS, Principal investigator, MVA/IVR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00789529
- Sponsor's protocol ID
- CS-101
- Status last verified
- Apr 2013
- First submitted
- 11 Nov 2008
- Last updated
- 31 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Testing of Tear Film Stability
- ClinicalTrials.gov ID
- NCT00789529
- Acronym / sponsor ID
- CS-101
- Conditions
- Contact Lens Solutions
- Keywords
- Contact lenses, wettability, Contact Lens Disinfectant Solutions, pre-lens tear film
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Manhattan Vision AssociatesUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Sep 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 13 Nov 2008 (estimated)
- Results
- Posted 31 May 2013
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 evaluate the in-vivo wettability of soft contact lenses when cared with two different multi-purpose solutions over a two week wearing period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Opti-Free® RepleniSH® MPDSOpti-Free® RepleniSH® MPDS |
| 2 | Active comparator | Device: ReNu MultiPlus®Renu MultiPlus® |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The subject must be at least 18 years of age and no more than 80 years of age.
- The subject must have a best corrected visual acuity of 20/30 or better for each eye.
- The subject must habitually wear contact lenses.
- The subject must have had an eye exam within the last 12 months. The exam data must be available to the investigators prior to the first visit.
- The subject must have normal eyes, no use of ocular medications, no ocular infection of any type, and no ocular inflammation.
Key exclusion criteria (9 listed)
- Ocular or systemic allergies or disease that might interfere with contact lens wear.
- Systemic disease, autoimmune disease or use of medication which might interfere with contact lens wear.
- Clinically significant (FDA Scale grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormalities of the cornea which would contraindicate contact lens wear.
- Clinically significant (FDA Scale grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
- Any ocular infection.
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® RepleniSH® MPDSsoft contact lens disinfecting solution | Device | 1 |
| ReNu MultiPlus®soft contact lens disinfecting solution | Device | 2 |
Primary outcome
Objective, In-vivo Soft Contact Lens Wettability Index
Time frame: 2 weeks
The wettability index is derived from the slope of a metric developed to measure the regularity of the Shack-Hartmann wavefront sensor image. The more wettable a lens is the more stable the metric and the slope of the metric (the wettability index) is closer to zero. The more negative values indicate a less wettable the lens.
1 secondary outcome
Subject Questionnaire Response
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Contact Lens Solutions
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Treating Contact Lens Discomfort With Varenicline Solution Nasal Spray 0.03mg
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Not yet recruitingPhase 3
Clinical Trial for the Evaluation of Safety and Efficacy of Drop 0.4%
Eye Dryness
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.
George Zikos, OS, MS principal investigator
MVA/IVR
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® MPDS and ReNu MultiPlus® in people with Contact Lens Solutions, run by Manhattan Vision Associates 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 7 inclusion and 9 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 31 May 2013. 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 31 May 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?
Objective, In-vivo Soft Contact Lens Wettability Index (time frame: 2 weeks). 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 31 May 2013.