Contact Lens SolutionNCT03073148
Evaluation of Tangible Boost Replenishing System
A study testing Tangible Boost in people with Contact Lens Solution, run by Tangible Science at 1 site in United States.
Trial summary
This study will evaluate Tangible Boost, a new contact lens care product which is designed to replenish the hydrogel layer on fluorosilicone acrylate lenses with Hydra-PEG. The Hydra-PEG coating is a poly(ethylene glycol)-based hydrogel that is covalently bound to the lens surface. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contact Lens Solution
- What is being tested?
- Tangible Boost
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2017to 13 Feb 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Habitual contact lens wear with a group 3 FDA approved rigid lens material, with 20-50% of subjects wearing corneal lenses
- Willing and able to sign the informed consent form
- 18 years or older
Who cannot join
- Eye injury or surgery within the 3 months immediately prior to enrollment for this trial
- Pre-existing ocular irritation that would preclude contact lens fitting
- Current enrollment in an ophthalmic clinical trial
- Evidence of systemic or ocular abnormality, infection, or disease which is likely to affect successful wear of contact lenses or use of the accessory solutions, as determined by the investigator
- Any use of medications for which contact lens wear could be contraindicated, as determined by the investigator
- Pregnant women and nursing mothers
- Visual acuity less than 20/20 when best corrected with contact lenses
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate Tangible Boost, a new contact lens care product which is designed to replenish the hydrogel layer on fluorosilicone acrylate lenses with Hydra-PEG. The Hydra-PEG coating is a poly(ethylene glycol)-based hydrogel that is covalently bound to the lens surface. This coating improves lens wettability, a common cause of patient discomfort. Tangible Boost is designed to maintain the wettability of Hydra-PEG lenses throughout the lens lifetime. Patients can use the Tangible Boost kit to reapply the Hydra-PEG coating each month at home.
- Conditions
- Contact Lens Solution
- Being tested
- Tangible Boost, Placebo saline
- Keywords
- Contact Lens Care Accessory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tangible BoostDevice
Participants will treat their lenses with Tangible Boost, a kit designed to maintain the wettability of Hydra-PEG treated fluorosilicone acrylate lenses.
Placebo salineOther
Participants will treat their lenses with a placebo "Tangible Boost" kit, which contains saline in place of the Tangible Boost solution.
| Study group | Role | What they receive |
|---|---|---|
| Tangible Boost | Experimental | Participants will treat their lenses with Tangible Boost after 30 days and again after 60 days. Receives: Device: Tangible Boost |
| Control | Placebo comparator | Participants will treat their lenses with a placebo "Tangible Boost" kit containing saline after 30 days and again after 60 days. Receives: Other: Placebo saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Adverse Event Reports or Discontinuations
A report of any adverse events or discontinuations that may have occurred. This measure includes adverse events unrelated to the treatment. See adverse events section for additional details.
Measured: Duration of study, 90 +/- 7 days after lens dispense visit.
Corneal Staining
Corneal staining with lissamine green was used to identify damage to the corneal cells, which may have been caused by the contact lenses or treatments in the study. 5 regions in each eye were scored on a scale of 0-4, resulting in a total possible range of 0-20. Left and right eye scores were averaged for each subject. A lower score indicates less corneal damage.
Measured: 1 day after treatment (day 31), final assessment (day 90)
Visual Acuity
Visual acuity was calculated on a logMAR scale using high luminance, high contrast acuity charts. On the logMAR scale, a score of 0 indicates no vision loss, with higher scores indicating more vision loss.
Measured: 1 day after treatment (day 31), final assessment (day 90)
Non-invasive Tear Film Break-up Time
Tear break-up time was measured with the OCULUS Keratograph.
Measured: 1 day after treatment (day 31), final assessment (day 90)
Number of Participants With Acceptable Lens Fit
Count of participants with acceptable lens fit (movement, centration, apical clearance, limbal clearance, and landing zone).
Measured: final assessment (day 90)
Secondary outcomes (2)
CLDEQ Score
The Contact Lens Dry Eye Questionnaire (CLDEQ) is used to evaluate the dry eye symptomology of contact lens wearers on a scale of 0-39. A lower score is indicative of greater comfort.
Measured: 1 day after treatment (day 31), final assessment (day 90)
Visual Analog Scale (VAS)
The subjective comfort of lenses was evaluated on a scale of 0-100, with higher scores indicating better comfort.
Measured: 1 day after treatment (day 31), final assessment (day 90)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start24 Feb 2017
- Primary completion13 Feb 2019
- Study completion13 Feb 2019
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 SolutionStudies 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
- Parallel groups
- Model description
- 2/3 of patients will be assigned to the Tangible Boost treatment arm of the study, and 1/3 of patients will be assigned to the placebo control arm.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tangible Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Houston
- Responsible party
- Sponsor
- Investigators
- Maria K Walker, OD MS, Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073148
- Sponsor's protocol ID
- 113133
- Status last verified
- Oct 2020
- First submitted
- 28 Feb 2017
- Last updated
- 17 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tangible Boost Replenishing System
- ClinicalTrials.gov ID
- NCT03073148
- Acronym / sponsor ID
- 113133
- Conditions
- Contact Lens Solution
- Keywords
- Contact Lens Care Accessory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Tangible ScienceIndustry (pharma, biotech, devices)
- Collaborators
- University of Houston
- Study start
- 24 Feb 2017 (actual)
- Primary completion
- 13 Feb 2019 (actual)
- Study completion
- 13 Feb 2019 (actual)
- First posted
- 8 Mar 2017 (actual)
- Results
- Posted 17 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate Tangible Boost, a new contact lens care product which is designed to replenish the hydrogel layer on fluorosilicone acrylate lenses with Hydra-PEG. The Hydra-PEG coating is a poly(ethylene glycol)-based hydrogel that is covalently bound to the lens surface. This coating improves lens wettability, a common cause of patient discomfort. Tangible Boost is designed to maintain the wettability of Hydra-PEG lenses throughout the lens lifetime. Patients can use the Tangible Boost kit to reapply the Hydra-PEG coating each month at home.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 2/3 of patients will be assigned to the Tangible Boost treatment arm of the study, and 1/3 of patients will be assigned to the placebo control arm.
| Arm | Type | Receives |
|---|---|---|
| Tangible Boost | Experimental | Device: Tangible BoostParticipants will treat their lenses with Tangible Boost after 30 days and again after 60 days. |
| Control | Placebo comparator | Other: Placebo salineParticipants will treat their lenses with a placebo "Tangible Boost" kit containing saline after 30 days and again after 60 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Habitual contact lens wear with a group 3 FDA approved rigid lens material, with 20-50% of subjects wearing corneal lenses
- Willing and able to sign the informed consent form
- 18 years or older
Key exclusion criteria (7 listed)
- Eye injury or surgery within the 3 months immediately prior to enrollment for this trial
- Pre-existing ocular irritation that would preclude contact lens fitting
- Current enrollment in an ophthalmic clinical trial
- Evidence of systemic or ocular abnormality, infection, or disease which is likely to affect successful wear of contact lenses or use of the accessory solutions, as determined by the investigator
- Any use of medications for which contact lens wear could be contraindicated, as determined by the investigator
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 |
|---|---|---|
| Tangible BoostParticipants will treat their lenses with Tangible Boost, a kit designed to maintain the wettability of Hydra-PEG treated fluorosilicone acrylate lenses. | Device | Tangible Boost |
| Placebo salineParticipants will treat their lenses with a placebo "Tangible Boost" kit, which contains saline in place of the Tangible Boost solution. | Other | Control |
Primary outcome
Number of Patients With Adverse Event Reports or Discontinuations
Time frame: Duration of study, 90 +/- 7 days after lens dispense visit.
A report of any adverse events or discontinuations that may have occurred. This measure includes adverse events unrelated to the treatment. See adverse events section for additional details.
Corneal Staining
Time frame: 1 day after treatment (day 31), final assessment (day 90)
Corneal staining with lissamine green was used to identify damage to the corneal cells, which may have been caused by the contact lenses or treatments in the study. 5 regions in each eye were scored on a scale of 0-4, resulting in a total possible range of 0-20. Left and right eye scores were averaged for each subject. A lower score indicates less corneal damage.
Visual Acuity
Time frame: 1 day after treatment (day 31), final assessment (day 90)
Visual acuity was calculated on a logMAR scale using high luminance, high contrast acuity charts. On the logMAR scale, a score of 0 indicates no vision loss, with higher scores indicating more vision loss.
Non-invasive Tear Film Break-up Time
Time frame: 1 day after treatment (day 31), final assessment (day 90)
Tear break-up time was measured with the OCULUS Keratograph.
Number of Participants With Acceptable Lens Fit
Time frame: final assessment (day 90)
Count of participants with acceptable lens fit (movement, centration, apical clearance, limbal clearance, and landing zone).
2 secondary outcomes
CLDEQ Score
Time frame: 1 day after treatment (day 31), final assessment (day 90)
Visual Analog Scale (VAS)
Time frame: 1 day after treatment (day 31), final assessment (day 90)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Tangible Science websiteLink provided by the sponsor.
Related trials for Contact Lens Solution
Recruiting
Treating Contact Lens Discomfort With Varenicline Solution Nasal Spray 0.03mg
Dry Eye
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.
Maria K Walker, OD MS principal investigator
University of Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tangible Boost in people with Contact Lens Solution, run by Tangible Science 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 3 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 17 Nov 2020. 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 17 Nov 2020). 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?
Number of Patients With Adverse Event Reports or Discontinuations (time frame: Duration of study, 90 +/- 7 days after lens dispense visit.). The study lists 5 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 17 Nov 2020.