Contact Lens WearNCT03537248
A Safety and Effectiveness Study of a New Multi-Purpose Contact Lens Care Solution
A study testing ASP-57 and ReNu® Multiplus in people with Contact Lens Wear, run by Asepticys LLC at 14 sites in United States.
Trial summary
The objective of this study is to evaluate the safety and effectiveness of ASP-57 Multi-Purpose contact lens solution (Test) compared to ReNu® Multiplus Contact Lens Solution (Control) when used by habitual contact lens wearers to bilaterally clean and disinfect their contact lenses for approximately 3 months (12… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contact Lens Wear
- What is being tested?
- ASP-57 and ReNu® Multiplus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 14 sitesUnited States
- Study dates
- 23 Apr 2018to 30 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects age ≥ 18 years on the date of informed consent.
- All subjects must provide signed written consent prior to participation in any study related procedures.
- Successful history of wear of the one of the following lens types (toric and multifocal lenses of the specified lens type are allowed) in both eyes during the past 3 months, and history of at least 5 consecutive days of successful daily wear in both eyes prior to Visit 1:
- All Bausch \& Lomb PureVision lens types
- All Alcon Air Optix lens types
- All CooperVision Biofinity lens types
Show all 14Show fewer
- All Vistakon Acuvue Oasys lens types
- Any conventional hydrogel Group IV lens
- Vision correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
- Clear central corneas and free of any anterior segment disorders
- Habitual use of a Multi-Purpose Solution for cleaning, disinfecting, and storage of lenses.
- Lens correction in both eyes is required and the same brand of lens is worn in each eye.
- Agree to wear study lenses in both eyes on a daily wear basis, with lenses removed every night (not slept in) throughout the study period and no lens or pair of lenses worn for longer than 2 weeks.
- Able and willing to comply with all care regimen and follow-up study procedures.
Who cannot join
- Females of childbearing potential (not surgically sterilized or postmenopausal) if any one of the following conditions are met:
- currently pregnant,
- plan to become pregnant during the study,
- are breast-feeding.
- Wear of gas permeable contact lenses within the last 30 days.
- Wear of polymethylmethacrylate lenses within the last 3 months.
Show all 17Show fewer
- No topical ocular prescription medications may be administered during the study period. Ongoing use of non-preserved artificial tears up to 4 times daily (with no changes in frequency or brand) is allowed. Ongoing use of the rewetting drop the subject customarily uses (with no switch in brand or type) is also permitted during the study period.
- Current systemic disease affecting ocular health or use of topical or systemic medications that, in the Investigator's opinion, could affect ocular physiology or lens performance.
- Ocular astigmatism of 2.00 D or greater in either eye based on the contact lens prescription.
- Grade 2 or greater finding on any slit-lamp scale and/or corneal infiltrates of any grade during slit-lamp examination at Screening.
- Any finding during slit-lamp examination that, in the Investigator's opinion, interferes with contact lens wear.
- Scar or neovascularization within the central 4 millimeters (mm) of the cornea. Minor peripheral corneal scarring (that does not extend into the central zone) is permitted, if in the Investigator's judgment, it does not interfere with contact lens wear.
- Aphakia.
- Amblyopia.
- History of any corneal surgery.
- Allergy to any component of the study solutions.
- Participation in any clinical study within the 2 weeks prior to entry into this study.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Drs Quinn, Foster & Associates
Athens, Ohio, 45701
Eye Care Associates
Bloomington, Illinois, 61701
Seidenberg Protzko Eye Associates
Havre de Grace, Maryland, 21078
Lakeside Vision Center
Irvine, California, 92604
Sabal Eye Care
Longwood, Florida, 32779
Maitland Vision Center
Maitland, Florida, 32751
Optometry Group
Memphis, Tennessee, 38111
Optique Eyecare
Nashville, Tennessee, 37203
Vision Health Institute
Orlando, Florida, 32803
Kannarr Eye Care
Pittsburg, Kansas, 66762
Complete Family Vision Care
San Diego, California, 92123
Heart of America Eye Care
Shawnee Mission, Kansas, 66204
Insight Eyecare
Warrensburg, Missouri, 64093
West Bay Eye
Warwick, Rhode Island, 02888
About this study
Official title: Clinical Safety and Effectiveness of ASP-57 Multi-Purpose Contact Lens Care Solution Compared to a Marketed Contact Lens Solution
The objective of this study is to evaluate the safety and effectiveness of ASP-57 Multi-Purpose contact lens solution (Test) compared to ReNu® Multiplus Contact Lens Solution (Control) when used by habitual contact lens wearers to bilaterally clean and disinfect their contact lenses for approximately 3 months (12 weeks).
Read the detailed description
Approximately 330 subjects (660 eyes) will be enrolled in this 3 month (12 week) controlled, parallel group, masked, randomized study at approximately 15 investigative sites in the United States. Subjects will be randomized 2:1 to receive either Asepticys ASP-57 Multi-Purpose Solution or ReNu® Multiplus Contact Lens Solution (Control) respectively. Both Test and Control solution will be used with a rub care regimen.
- Conditions
- Contact Lens Wear
- Being tested
- ASP-57, ReNu® Multiplus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP-57Device
Also called Investigational Multi-Purpose Contact Lens Care Solution
an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, ad storing soft contact lenses including silicone hydrogel lenses
ReNu® MultiplusDevice
a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, ad storing soft contact lenses including silicone hydrogel lenses
| Study group | Role | What they receive |
|---|---|---|
| Asepticys investigational ASP-57 Multi-Purpose Solution | Experimental | ASP-57 Multi-Purpose contact lens care solution used as a rub care regimen (Test) Receives: Device: ASP-57 |
| ReNu® Multiplus Contact Lens Solution | Active comparator | ReNu® Multiplus Contact Lens Solution used as rub care regimen (Control) Receives: Device: ReNu® Multiplus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slit Lamp Findings
Statistical non-inferiority with respect to the proportion of eyes with any slit-lamp findings greater than Grade 2 at any visit between the test and control solutions
Measured: 3 months
Visual Acuity
Statistical non-inferiority with respect to the proportion of subjects with greater than 2-line worsening in visual acuity in any eye at any visit between the test and control solutions
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start23 Apr 2018
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asepticys LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537248
- Sponsor's protocol ID
- ASP-57-101
- Status last verified
- Jun 2018
- First submitted
- 15 May 2018
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Safety and Effectiveness of ASP-57 Multi-Purpose Contact Lens Care Solution Compared to a Marketed Contact Lens Solution
- ClinicalTrials.gov ID
- NCT03537248
- Acronym / sponsor ID
- ASP-57-101
- Conditions
- Contact Lens Wear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Asepticys LLCIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 25 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the safety and effectiveness of ASP-57 Multi-Purpose contact lens solution (Test) compared to ReNu® Multiplus Contact Lens Solution (Control) when used by habitual contact lens wearers to bilaterally clean and disinfect their contact lenses for approximately 3 months (12 weeks).
Detailed description
Approximately 330 subjects (660 eyes) will be enrolled in this 3 month (12 week) controlled, parallel group, masked, randomized study at approximately 15 investigative sites in the United States. Subjects will be randomized 2:1 to receive either Asepticys ASP-57 Multi-Purpose Solution or ReNu® Multiplus Contact Lens Solution (Control) respectively. Both Test and Control solution will be used with a rub care regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asepticys investigational ASP-57 Multi-Purpose Solution | Experimental | Device: ASP-57ASP-57 Multi-Purpose contact lens care solution used as a rub care regimen (Test) |
| ReNu® Multiplus Contact Lens Solution | Active comparator | Device: ReNu® MultiplusReNu® Multiplus Contact Lens Solution used as rub care regimen (Control) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects age ≥ 18 years on the date of informed consent.
- All subjects must provide signed written consent prior to participation in any study related procedures.
- Successful history of wear of the one of the following lens types (toric and multifocal lenses of the specified lens type are allowed) in both eyes during the past 3 months, and history of at least 5 consecutive days of successful daily wear in both eyes prior to Visit 1:
- Vision correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
- Clear central corneas and free of any anterior segment disorders
Key exclusion criteria (17 listed)
- Females of childbearing potential (not surgically sterilized or postmenopausal) if any one of the following conditions are met:
- Wear of gas permeable contact lenses within the last 30 days.
- Wear of polymethylmethacrylate lenses within the last 3 months.
- No topical ocular prescription medications may be administered during the study period. Ongoing use of non-preserved artificial tears up to 4 times daily (with no changes in frequency or brand) is allowed. Ongoing use of the rewetting drop the subject customarily uses (with no switch in brand or type) is also permitted during the study period.
- Current systemic disease affecting ocular health or use of topical or systemic medications that, in the Investigator's opinion, could affect ocular physiology or lens performance.
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 |
|---|---|---|
| ASP-57Also: Investigational Multi-Purpose Contact Lens Care Solutionan experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, ad storing soft contact lenses including silicone hydrogel lenses | Device | Asepticys investigational ASP-57 Multi-Purpose Solution |
| ReNu® Multiplusa multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, ad storing soft contact lenses including silicone hydrogel lenses | Device | ReNu® Multiplus Contact Lens Solution |
Primary outcome
Slit Lamp Findings
Time frame: 3 months
Statistical non-inferiority with respect to the proportion of eyes with any slit-lamp findings greater than Grade 2 at any visit between the test and control solutions
Visual Acuity
Time frame: 3 months
Statistical non-inferiority with respect to the proportion of subjects with greater than 2-line worsening in visual acuity in any eye at any visit between the test and control solutions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Contact Lens Wear
Recruiting
Wear Experience With Daily Disposable Contact Lenses for Astigmatism Over a Long-Wear Day
Astigmatism
Active, not recruiting
The A.R.R.E.S.T.® Contact Lens Study
Myopia, Myopia Progression
RecruitingPhase 4
Single-Arm Study of a Treatment for Dry Eye in People Who Struggle to Wear Contact Lenses
Dry Eye
Enrolling by invitation
Assessment of the Relationship of Soft Contact Lens Fit and Power (Fit & Lens pOwer Soft lenSes)
Healthy Participants Study, Contact Lens Wear
Active, not recruiting
Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear
Myopia
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.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASP-57 and ReNu® Multiplus in people with Contact Lens Wear, run by Asepticys LLC at 14 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 14 inclusion and 17 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 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Slit Lamp Findings (time frame: 3 months). 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 11 Feb 2019.