AmetropiaNCT02249689
Three-month Clinical Evaluation of Silicone Hydrogel Definitive 65 Contact Lenses
A study testing Definitive 65 and Definitive 74 in people with Ametropia, run by Contamac Ltd at 2 sites in Germany.
Trial summary
Comparison of different contact lens materials. 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?
- Definitive 65 and Definitive 74
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2014to May 2014
- 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
- ages 18 years or older
- 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)
- astigmatic power equal to or less than 0.75 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 use of 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 9Show fewer
- current monovision leans wearers
- 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
Comparison of different contact lens materials.
Read the detailed description
This will be a 3-month, open-label, bilateral, parallel-group, randomised, daily wear study. Two-thirds of the subjects will wear the Test lenses in both eyes, and one-third will wear the Control lenses in both eyes.
- Conditions
- Ametropia
- Being tested
- Definitive 65, Definitive 74
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Definitive 65Other
Definitive 74Other
| Study group | Role | What they receive |
|---|---|---|
| Definitive 65 | Experimental | The Test product were the Definitive 65 (Filcon V4) lenses. This material is produced by Contamac Ltd. and the contact lenses were manufactured by Appenzeller Kontaktlinsen AG. Receives: Other: Definitive 65 |
| Definitive 74 | Active comparator | The Control product was the commercially available Definitive 74 (Efrofilcon A) lens. This material is produced by Contamac Ltd. and the contact lenses were manufactured by Appenzeller Kontaktlinsen AG. Receives: Other: Definitive 74 |
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 three months
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 three months
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 three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2014
- Study completionMay 2014
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
- None (open label)
- Enrolment
- 60 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, Principal investigator, Hartwig Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249689
- Sponsor's protocol ID
- CM-001-001
- Status last verified
- Aug 2020
- First submitted
- 19 Jan 2014
- 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
- Three-month Clinical Evaluation of Silicone Hydrogel Definitive 65 Contact Lenses
- ClinicalTrials.gov ID
- NCT02249689
- Acronym / sponsor ID
- CM-001-001
- Conditions
- Ametropia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Contamac LtdIndustry (pharma, biotech, devices)
- Collaborators
- Hartwig Research Center
- Study start
- Jan 2014
- Primary completion
- Jan 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 25 Sep 2014 (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.
Comparison of different contact lens materials.
Detailed description
This will be a 3-month, open-label, bilateral, parallel-group, randomised, daily wear study. Two-thirds of the subjects will wear the Test lenses in both eyes, and one-third will wear the Control lenses in both eyes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Definitive 65 | Experimental | Other: Definitive 65The Test product were the Definitive 65 (Filcon V4) lenses. This material is produced by Contamac Ltd. and the contact lenses were manufactured by Appenzeller Kontaktlinsen AG. |
| Definitive 74 | Active comparator | Other: Definitive 74The Control product was the commercially available Definitive 74 (Efrofilcon A) lens. This material is produced by Contamac Ltd. and the contact lenses were manufactured by Appenzeller Kontaktlinsen AG. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- willing and able to sign the informed consent form
- ages 18 years or older
- 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)
- astigmatic power equal to or less than 0.75 D
Key exclusion criteria (9 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 use of 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 |
|---|---|---|
| Definitive 65 | Other | Definitive 65 |
| Definitive 74 | Other | Definitive 74 |
Primary outcome
questionnaire addressing subjective comfort and wear time
Time frame: subjects will be followed-up for three months
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 three months
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 three months
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 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.
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Comparison of Low- Versus High-Level Angle Kappa Compensation Strategies in SMILE Using the VisuMax 800: A Randomized Clinical Trial
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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 Definitive 65 and Definitive 74 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 5 inclusion and 9 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 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 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 three months). 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.