AmetropiaNCT02553681
Clinical Evaluation of HPT Treated Rigid Contact Lenses Made From Roflufocon D
A study testing roflufocon D contact lenses and RGP contact lenses made from roflufocon D in people with Ametropia, run by Contamac Ltd at 1 site in Germany.
Trial summary
This will be an up to six months, subject-masked, contralateral, parallel-group, randomised, daily wear study. All subjects will wear the Test lens in one eye and the Control lens in the other eye. Data from the first four weeks of Test and Control lens exposure will be used for the FDA 510 (k) submission. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ametropia
- What is being tested?
- roflufocon D contact lenses and RGP contact lenses made from roflufocon D
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2015to 16 Feb 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing and able to sign the informed consent form
- Aged ≥18 years old
- Experienced wearer of rigid gas permeable contact lenses
- Subject's habitual contact lenses must be made of Contamac's Optimum Extra (roflufocon D) material
- Subjects must have owned spectacles or contact lenses prior to enrolment for this trial
- Spherical power between -10.00 D and +10.00 D (at vertex distance 0 mm)
Show all 21Show fewer
- Corneal astigmatism ≤2.00 D
- Exclusion Criteria:• Eye injury or surgery within 3 months immediately prior to enrolment for this trial
- Pre-existing ocular irritation that would preclude contact lens fitting
- Currently enrolled 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 contradicted, as determined by the investigator
- Current extended-wear users (sleep-in overnight)
- Current monovision lens wearers
- Current wearers of multifocal contact lenses
- Current wearers of toric contact lenses (front surface design)
- Current wearers of astigmatic contact lenses (posterior surface design)
- Has a reported "Strong" comfort or vision preference between each eye with their habitual RGP lenses
- Unacceptable fit of habitual lenses
- Pregnant women and nursing mothers
- Best-corrected visual acuity worse than 6/9 (LogMAR: +0.20; Snellen decimal: 0.63)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Hydra-PEG (Polyethylene Glycol) Treatment (HPT) Treated Rigid Contact Lenses Made From Roflufocon D
This will be an up to six months, subject-masked, contralateral, parallel-group, randomised, daily wear study. All subjects will wear the Test lens in one eye and the Control lens in the other eye. Data from the first four weeks of Test and Control lens exposure will be used for the FDA 510 (k) submission.
- Conditions
- Ametropia
- Being tested
- roflufocon D contact lenses, RGP contact lenses made from roflufocon D
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
roflufocon D contact lensesDevice
HPT treated rigid contact lenses
RGP contact lenses made from roflufocon DDevice
| Study group | Role | What they receive |
|---|---|---|
| HPT treated | Experimental | Hydra-PEG Treatment (HPT) treated RGP contact lenses made from roflufocon D Receives: Device: roflufocon D contact lenses |
| untreated | Active comparator | untreated RGP contact lenses made from roflufocon D Receives: Device: RGP contact lenses made from roflufocon D |
What is being measured
The primary outcome is the main question the study is designed to answer.
questionnaire addressing subjective comfort and wear time
Subjects rated on a scale from 1 to 10, where 1 was 'poor' and 10 was 'excellent'.
Measured: subjects will be followed-up for one month
conjunctival redness - ocular biomicroscopy
Graded based on a grading scale which ranged from 0 to 4, where 0 is none, 1 is trace, 2 is mild, 3 is moderate and 4 is severe.
Measured: subjects will be followed-up for one month
corneal staining - ocular biomicroscopy
Graded based on a grading scale which ranged from 0 to 4, where 0 is none, 1 is trace, 2 is mild, 3 is moderate and 4 is severe.
Measured: subjects will be followed-up for one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startJul 2015
- Primary completionFeb 2017
- Study completion16 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmetropiaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Contamac Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hartwig Research Center
- Responsible party
- Sponsor
- Investigators
- Andreas Hartwig, PhD, FAAO, Principal investigator, Hartwig Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553681
- Sponsor's protocol ID
- CM-002-001
- Status last verified
- Aug 2020
- First submitted
- 22 Jul 2015
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Hydra-PEG (Polyethylene Glycol) Treatment (HPT) Treated Rigid Contact Lenses Made From Roflufocon D
- ClinicalTrials.gov ID
- NCT02553681
- Acronym / sponsor ID
- CM-002-001
- Conditions
- Ametropia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Contamac LtdIndustry (pharma, biotech, devices)
- Collaborators
- Hartwig Research Center
- Study start
- Jul 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- 16 Feb 2017 (actual)
- First posted
- 17 Sep 2015 (estimated)
- 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.
This will be an up to six months, subject-masked, contralateral, parallel-group, randomised, daily wear study. All subjects will wear the Test lens in one eye and the Control lens in the other eye. Data from the first four weeks of Test and Control lens exposure will be used for the FDA 510 (k) submission.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPT treated | Experimental | Device: roflufocon D contact lensesHydra-PEG Treatment (HPT) treated RGP contact lenses made from roflufocon D |
| untreated | Active comparator | Device: RGP contact lenses made from roflufocon Duntreated RGP contact lenses made from roflufocon D |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Willing and able to sign the informed consent form
- Aged ≥18 years old
- Experienced wearer of rigid gas permeable contact lenses
- Subject's habitual contact lenses must be made of Contamac's Optimum Extra (roflufocon D) material
- Subjects must have owned spectacles or contact lenses prior to enrolment for this trial
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| roflufocon D contact lensesHPT treated rigid contact lenses | Device | HPT treated |
| RGP contact lenses made from roflufocon D | Device | untreated |
Primary outcome
questionnaire addressing subjective comfort and wear time
Time frame: subjects will be followed-up for one month
Subjects rated on a scale from 1 to 10, where 1 was 'poor' and 10 was 'excellent'.
conjunctival redness - ocular biomicroscopy
Time frame: subjects will be followed-up for one month
Graded based on a grading scale which ranged from 0 to 4, where 0 is none, 1 is trace, 2 is mild, 3 is moderate and 4 is severe.
corneal staining - ocular biomicroscopy
Time frame: subjects will be followed-up for one month
Graded based on a grading scale which ranged from 0 to 4, where 0 is none, 1 is trace, 2 is mild, 3 is moderate and 4 is severe.
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 12 Aug 2020.
Related trials for Ametropia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Not yet recruiting
Comparison of Two Rotational Alignment Methods for Astigmatism Correction in SMILE Surgery
Myopia, Refractive Ametropia
Recruiting
The Impact of 'A Miss Is as Good as a Mile': Is Compensation Necessary for Minimal Ocular Deviation in Myopic Laser Surgery?
Myopia, Refractive Ametropia
Recruiting
Comparison of Low- Versus High-Level Angle Kappa Compensation Strategies in SMILE Using the VisuMax 800: A Randomized Clinical Trial
Myopia, Refractive Ametropia
Recruiting
A Study to Evaluate the Clinical Performance and Safety of UNICON Silicone Hydrogel Daily Disposable Soft Contact Lenses
Refractive Ametropia
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.
Andreas Hartwig, PhD, FAAO principal investigator
Hartwig Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing roflufocon D contact lenses and RGP contact lenses made from roflufocon D in people with Ametropia, run by Contamac Ltd at 1 site in Germany.
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 21 inclusion and 0 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 12 Aug 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 Germany. 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?
questionnaire addressing subjective comfort and wear time (time frame: subjects will be followed-up for one month). The study lists 3 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 12 Aug 2020.