Study Focus is Healthy Contact Lens WearersPhase 3NCT00961051
Evaluation of an Investigational Multi-Purpose Solution (MPS)
A Phase 3 study testing Investigational MPS and Opti-Free in people with Study Focus is Healthy Contact Lens Wearers, run by Abbott Medical Optics at 9 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of an investigational multi-purpose contact lens solution. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Study Focus is Healthy Contact Lens Wearers
- What is being tested?
- Investigational MPS and Opti-Free
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 9 sitesUnited States
- Study dates
- Feb 2009to Nov 2009
- Phase
- Phase 3
- 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
- Have successfully worn hydrogel contact lenses of the same material to be worn during the study
- Have normal eyes (with the exception of unaided visual acuity)
- Have successfully used a multi-purpose contact lens care solution
- Have acceptable visual acuity and lens wearing comfort at time of enrollment
Who cannot join
- Concurrently enrolled another clinical trial
- Have a known sensitivity to any study product ingredient(s)
- Have a condition that may put them at significant risk
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Drs. Quinn, Quinn & Associates
Athens, Ohio, 45701
Western Reserve Vision Care
Beachwood, Ohio, 44122
Central Ohio Eyecare
Columbus, Ohio, 43202
Complete Family Vision Center
San Diego, California, 92123
Northeastern Eye Institute
Scranton, Pennsylvania, 18503
Eye Care Associates of Hawaii
Waipahu, Hawaii, 96797
Insight Eyecare
Warrensburg, Missouri, 64093
West Bay Eye Associates
Warwick, Rhode Island, 02888
Ziegler Leffingwell Eyecare
West Allis, Wisconsin, 53227
About this study
Official title: Evaluation of an Investigational MPS
The purpose of this study is to evaluate the safety and effectiveness of an investigational multi-purpose contact lens solution.
Read the detailed description
A new multi-purpose solution has been developed for optimal lens disinfection and lens wearing comfort, compatible with a wide variety of commercially available lenses. Ten investigative sites were selected to evaluate 274 soft contact lens wearers in a parallel group study of one investigational multi-purpose solution and one marketed predicate solution.
- Being tested
- Investigational MPS, Opti-Free
- Keywords
- adapted contact lens wearers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational MPSDevice
Also called Cobra
Multi-purpose solution
Opti-FreeDevice
Also called RepleniSH
Multi-purpose solution
| Study group | Role | What they receive |
|---|---|---|
| Investigational MPS | Experimental | Investigational multipurpose disinfecting solution (study MPS) Receives: Device: Investigational MPS |
| Predicate MPS | Active comparator | Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS) Receives: Device: Opti-Free |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Lens Cleanliness as Measured by Light Reflectance
Lens cleanliness was assessed by total light reflectance, which is a computerized quantitative assessment conducted in a laboratory. The amount of light that scattered off the lens surface in a light field and was assessed using a light reflectance score that ranged from 0 (maximum lens cleanliness; clean/clear) to100 (minimum lens cleanliness; dirty/opaque).
Measured: Day 30
Secondary outcomes (1)
Number of Subjects With no Corneal Staining
Corneal staining was performed via slit lamp observation of the corneal through a cobalt blue filter and a yellow #12 or #15 filter Wratten filter following contact lens removal and installation of standard sodium fluorescein.
Measured: Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2009 (estimated)
- Study startFeb 2009
- Primary completionAug 2009
- Study completionNov 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.
- Other trials for Study Focus is Healthy Contact Lens WearersStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Optics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicholas Tarantino, OD, Study chair, Abbott Medical Optics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961051
- Sponsor's protocol ID
- COBR-105-9608
- Status last verified
- Dec 2013
- First submitted
- 27 Jul 2009
- Last updated
- 7 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Investigational MPS
- ClinicalTrials.gov ID
- NCT00961051
- Acronym / sponsor ID
- COBR-105-9608
- Keywords
- adapted contact lens wearers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Abbott Medical OpticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 18 Aug 2009 (estimated)
- Results
- Posted 7 Jan 2014
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 safety and effectiveness of an investigational multi-purpose contact lens solution.
Detailed description
A new multi-purpose solution has been developed for optimal lens disinfection and lens wearing comfort, compatible with a wide variety of commercially available lenses. Ten investigative sites were selected to evaluate 274 soft contact lens wearers in a parallel group study of one investigational multi-purpose solution and one marketed predicate solution.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational MPS | Experimental | Device: Investigational MPSInvestigational multipurpose disinfecting solution (study MPS) |
| Predicate MPS | Active comparator | Device: Opti-FreeOpti-Free RepleniSH multipurpose disinfecting solution (predicate MPS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have successfully worn hydrogel contact lenses of the same material to be worn during the study
- Have normal eyes (with the exception of unaided visual acuity)
- Have successfully used a multi-purpose contact lens care solution
- Have acceptable visual acuity and lens wearing comfort at time of enrollment
Key exclusion criteria (3 listed)
- Concurrently enrolled another clinical trial
- Have a known sensitivity to any study product ingredient(s)
- Have a condition that may put them at significant risk
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 |
|---|---|---|
| Investigational MPSAlso: CobraMulti-purpose solution | Device | Investigational MPS |
| Opti-FreeAlso: RepleniSHMulti-purpose solution | Device | Predicate MPS |
Primary outcome
Mean Lens Cleanliness as Measured by Light Reflectance
Time frame: Day 30
Lens cleanliness was assessed by total light reflectance, which is a computerized quantitative assessment conducted in a laboratory. The amount of light that scattered off the lens surface in a light field and was assessed using a light reflectance score that ranged from 0 (maximum lens cleanliness; clean/clear) to100 (minimum lens cleanliness; dirty/opaque).
1 secondary outcome
Number of Subjects With no Corneal Staining
Time frame: Day 180
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Nicholas Tarantino, OD study chair
Abbott Medical Optics
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Investigational MPS and Opti-Free in people with Study Focus is Healthy Contact Lens Wearers, run by Abbott Medical Optics at 9 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 4 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 7 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 7 Jan 2014). 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?
Mean Lens Cleanliness as Measured by Light Reflectance (time frame: Day 30). 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 7 Jan 2014.