Vision CorrectionNCT01197859
Three Month Clinical Evaluation of the Contamac 74% Silicone Hydrogel Contact Lens
A study testing Definitive Contact Lens and Biofinity in people with Vision Correction, run by Contamac Ltd at 1 site in United Kingdom.
Trial summary
The purpose of this study is to compare the clinical performance of the contamac silicone hydrogel contact lens with a predicate device (Cooper Vision Biofinity). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vision Correction
- What is being tested?
- Definitive Contact Lens and Biofinity
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2008to Feb 2009
- 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
- existing contact lens wearer
- read and signed statement of informed consent
- has clear central cornea
- requires spherical distance correction
Who cannot join
- has worn RGP contact lenses within the last 30 days
- is using any ocular medication
- has had refractive surgery
- has an infectious disease
- is pregnant or lactating
- is participating in another clinical research study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the clinical performance of the contamac silicone hydrogel contact lens with a predicate device (Cooper Vision Biofinity).
Read the detailed description
The purpose of this study is to evaluate the clinical performance of the Contamac lens in comparison with a currently marketed silicone hydrogel: Biofinity® (CooperVision). This is a 3-month, open-label, bilateral, parallel group, randomised, daily wear study. Approx. two-thirds of the subjects will wear the Contamac Silicone Hydrogel lens in both eyes while the other third will wear control lenses.
- Conditions
- Vision Correction
- Being tested
- Definitive Contact Lens, Biofinity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Definitive Contact LensDevice
Daily wear contact lens
BiofinityDevice
Daily wear contact lens
| Study group | Role | What they receive |
|---|---|---|
| Contamac 74% silicone hydrogel contact lens | Active comparator | Definitive Contact Lens Receives: Device: Definitive Contact Lens |
| Cooper Vision Biofinity | Placebo comparator | Biofinity Contact Lens Receives: Device: Biofinity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess performance variables as compared to the predicate device during follow-up visits to demonstrate safety and efficacy.
The clinical study will assess the following performance variables as compared to the predicate device during 5 follow-up visits over a 3 month period to demonstrate safety and efficacy: Sphere-cyl Refraction and VA, Keratometry, Comfort, Handling, Symptoms, Over-Refraction and VA, Lens Fit, Lens Deposits, and Slit Lamp Findings.
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 posted9 Sep 2010 (estimated)
- Study startAug 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vision CorrectionStudies 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
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Contamac Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Graeme Young, Principal investigator, Vision Care Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197859
- Sponsor's protocol ID
- CCSH-1901
- Status last verified
- Aug 2020
- First submitted
- 2 Sep 2010
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 the Contamac 74% Silicone Hydrogel Contact Lens
- ClinicalTrials.gov ID
- NCT01197859
- Acronym / sponsor ID
- CCSH-1901
- Conditions
- Vision Correction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Contamac LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2008 (actual)
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 9 Sep 2010 (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.
The purpose of this study is to compare the clinical performance of the contamac silicone hydrogel contact lens with a predicate device (Cooper Vision Biofinity).
Detailed description
The purpose of this study is to evaluate the clinical performance of the Contamac lens in comparison with a currently marketed silicone hydrogel: Biofinity® (CooperVision). This is a 3-month, open-label, bilateral, parallel group, randomised, daily wear study. Approx. two-thirds of the subjects will wear the Contamac Silicone Hydrogel lens in both eyes while the other third will wear control lenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contamac 74% silicone hydrogel contact lens | Active comparator | Device: Definitive Contact LensDefinitive Contact Lens |
| Cooper Vision Biofinity | Placebo comparator | Device: BiofinityBiofinity Contact Lens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- existing contact lens wearer
- read and signed statement of informed consent
- has clear central cornea
- requires spherical distance correction
Key exclusion criteria (6 listed)
- has worn RGP contact lenses within the last 30 days
- is using any ocular medication
- has had refractive surgery
- has an infectious disease
- is pregnant or lactating
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 Contact LensDaily wear contact lens | Device | Contamac 74% silicone hydrogel contact lens |
| BiofinityDaily wear contact lens | Device | Cooper Vision Biofinity |
Primary outcome
Assess performance variables as compared to the predicate device during follow-up visits to demonstrate safety and efficacy.
Time frame: 3 months
The clinical study will assess the following performance variables as compared to the predicate device during 5 follow-up visits over a 3 month period to demonstrate safety and efficacy: Sphere-cyl Refraction and VA, Keratometry, Comfort, Handling, Symptoms, Over-Refraction and VA, Lens Fit, Lens Deposits, and Slit Lamp Findings.
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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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.
Graeme Young principal investigator
Vision Care Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Definitive Contact Lens and Biofinity in people with Vision Correction, run by Contamac Ltd at 1 site in United Kingdom.
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 4 inclusion and 6 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 United Kingdom. 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?
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?
Assess performance variables as compared to the predicate device during follow-up visits to demonstrate safety and efficacy. (time frame: 3 months). 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.