AmetropiaNCT04525170
Clinical Evaluation of HPT Treated Rigid Contact Lenses Made From Hexafocon A
A study testing HPT treatment and untreated in people with Ametropia, run by Contamac Ltd at 2 sites 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?
- HPT treatment and untreated
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesGermany
- Study dates
- Sep 2015to Dec 2015
- 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 Boston XO (hexafocon A) 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)
- Corneal astigmatism ≤2.00 D
Who cannot join
- 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)
Show all 14Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Clinical Evaluation of Hydra-PEG (Polyethylene Glycol) Treatment (HPT) Treated Rigid Contact Lenses Made From Hexafocon A
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
- HPT treatment, untreated
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPT treatmentDevice
Also called Hydra-PEG (Polyethylene Glycol) Treatment
untreatedDevice
| Study group | Role | What they receive |
|---|---|---|
| HPT treated | Experimental | daily wear Hexafocon A rigid contact lens treated with Hydra PEG surface coating Receives: Device: HPT treatment |
| untreated | Experimental | daily wear Hexafocon A rigid contact lens Receives: Device: untreated |
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
limbal redness - ocular biomicroscopy
Findings were 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
Findings were 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 posted25 Aug 2020
- Study startSep 2015
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: It was decided by the sponsor to not proceed.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Contamac Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andreas Hartwig, PhD, Principal investigator, Hartwig Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525170
- Sponsor's protocol ID
- CM-002-002
- Status last verified
- Aug 2020
- First submitted
- 2 Oct 2015
- Last updated
- 25 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 25 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 Hexafocon A
- ClinicalTrials.gov ID
- NCT04525170
- Acronym / sponsor ID
- CM-002-002
- Conditions
- Ametropia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: It was decided by the sponsor to not proceed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Contamac LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2015 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Aug 2020 (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.
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: HPT treatmentdaily wear Hexafocon A rigid contact lens treated with Hydra PEG surface coating |
| untreated | Experimental | Device: untreateddaily wear Hexafocon A rigid contact lens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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 Boston XO (hexafocon A) material
- Subjects must have owned spectacles or contact lenses prior to enrolment for this trial
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| HPT treatmentAlso: Hydra-PEG (Polyethylene Glycol) Treatment | Device | HPT treated |
| untreated | 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'.
limbal redness - ocular biomicroscopy
Time frame: subjects will be followed-up for one month
Findings were 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
Findings were 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 was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
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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 principal investigator
Hartwig Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPT treatment and untreated in people with Ametropia, run by Contamac Ltd at 2 sites 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 7 inclusion and 14 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: withdrawn, as of the sponsor's last update on 25 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 2 sites 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 was withdrawn before enrolling participants, so there are no results.
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 25 Aug 2020.