HealthyNCT01392937
Clinical Performance of All-in-One Light Multi-purpose for Silicone Hydrogel Contact Lenses
A study testing All-in-One Light multipurpose and Aquify care in people with Healthy, run by Sauflon Pharmaceuticals Ltd at 1 site in United Kingdom.
Trial summary
A clinical trial was conducted to assess the safety and acceptability of the Sauflon Multipurpose Solution when used with four different silicone hydrogel contact lens brands and one conventional hydrogel control lens was conducted over a period of two months, with a control group using Ciba Vision Aquify Multi… Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- All-in-One Light multipurpose and Aquify care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2010to Mar 2011
- 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 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects will only be eligible for the study if:
- They are 18 years of age and above.
- They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
- They are willing and able to follow the protocol.
- They agree not to participate in other clinical research for the duration of this study.
- They can attain at least 6/12 in each eye with the study contact lenses.
- They have successfully worn contact lenses within six months of starting the study.
- They can be fitted with spherical soft contact lenses within the power ranges of the study lenses.
Who cannot join
- Subjects will not be eligible if:
- They have an ocular disorder which would normally contra-indicate contact lens wear.
- They have a systemic disorder which would normally contra-indicate contact lens wear.
- They are using any topical medication such as eye drops or ointment.
- They are aphakic.
- They have had corneal refractive surgery.
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- They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
- They are pregnant or lactating.
- They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
- They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Eurolens Research Faculty of Life Sciences The University of Manchester
Manchester, Manchester
About this study
Official title: The Clinical Performance of the All-in-One Light Multi-purpose Care Regimen for Silicone Hydrogel Contact Lenses
A clinical trial was conducted to assess the safety and acceptability of the Sauflon Multipurpose Solution when used with four different silicone hydrogel contact lens brands and one conventional hydrogel control lens was conducted over a period of two months, with a control group using Ciba Vision Aquify Multi- Purpose Solution. The study was conducted at six investigator sites and a total of 257 subjects were enrolled. The results of this study showed the safety, acceptability and substantial equivalence of the Sauflon Multipurpose Solution to the predicate device for its intended use.
Read the detailed description
1.1 Study characteristics This study evaluated the safety and efficacy of the All-in-One Light multipurpose care regimen (Sauflon Pharmaceuticals Limited) by comparison with the Aquify care regimen(Ciba Vision Inc.). Each subject used one of five different lens brands: Air Optix Aqua(Ciba Vision Inc.), PureVision (Bausch + Lomb Inc.), Biofinity (CooperVision Inc.), Acuvue Advance and Acuvue 2 (both Johnson \& Johnson).
The key study features were as follows:
- Two months duration.
- Six investigator sites.
- Daily wear soft (hydrophilic) contact lenses, replaced on a two-weekly basis: Air Optix Aqua, PureVision, Biofinity, Acuvue Advance and Acuvue 2; with one of two care regimens: All-in-One Light and Aquify.
- A total of 257 subjects were enrolled, and 256 subjects accounting for 512 eyes were dispensed lenses. This group was randomized into 173 test subjects (346 eyes) and 83 control subjects (166 eyes).
- Of the 173 test subjects, 163 (94.2%) completed two months of use. Of the 83 control subjects, 73 (88.0%) completed two months of use.
- No eyes remained active at the end of the study.
- There were no adverse reactions. 1.2 Study period The study was conducted over two months of wear. Subjects were examined initially, and at three follow-up visits after two weeks, one month and two months. Study visits commenced on March 29, 2010 and were completed on March 11, 2011.
1.3 Demographics Six investigator sites dispensed 173 test subjects (346 eyes) who used All-in-One Light as their care regimen during the work. Also dispensed were 83 control subjects (166 eyes)who used Aquify as their care regimen during the work. All recruited subjects were existing contact lenses wearers.
Of the 173 test subjects, 163 (94.2%) completed two months of use and ten (5.8%) were discontinued. Of the 83 control subjects, 73 (88.0%) completed two months of use and ten (12.2%) were discontinued.
The enrolled control group was made up of 51 females (61%) and 32 males (39%) with an age range from 18 to 67 years (mean 36.7 years). The enrolled test group was composed of 117 females (67%) and 57 males (33%) with an age range from 18 to 65 years (mean 34.1 years). One subject (female, age 45 years) was enrolled and assigned to the test group but was not dispensed lenses.
- Conditions
- Healthy
- Being tested
- All-in-One Light multipurpose, Aquify care
- Keywords
- AIOL, multipurpose solution, silicone hydrogel lenses, The safety and efficacy of the All-in-One Light multipurpose care regimen by comparison with the Aquify care regimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All-in-One Light multipurposeDevice
The study was conducted over two months of wear. Subjects were examined initially, and at three follow-up visits after two weeks, one month and two months.
Aquify careDevice
The study was conducted over two months of wear. Subjects were examined initially, and at three follow-up visits after two weeks, one month and two months.
| Study group | Role | What they receive |
|---|---|---|
| All-in-One Light multipurpose | Active comparator | Used All in One light multipurpose with one of five different lens brands: Air Optix Aqua(Ciba Vision Inc.), PureVision (Bausch + Lomb Inc.), Biofinity (CooperVision Inc.), Acuvue Advance and Acuvue 2 (both Johnson \& Johnson). Receives: Device: All-in-One Light multipurpose |
| Aquify care | Active comparator | Use Aquify care with one of five different lens brands: Air Optix Aqua(Ciba Vision Inc.), PureVision (Bausch + Lomb Inc.), Biofinity (CooperVision Inc.), Acuvue Advance and Acuvue 2 (both Johnson \& Johnson). Receives: Device: Aquify care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall subjective acceptance.
The safety and efficacy of the All-in-One Light multipurpose care regimen (Sauflon Pharmaceuticals Limited) by comparison with the Aquify care regimen(Ciba Vision Inc.). Each subject used one of five different lens brands: Air Optix Aqua(Ciba Vision Inc.), PureVision (Bausch + Lomb Inc.), Biofinity (CooperVision Inc.), Acuvue Advance and Acuvue 2 (both Johnson \& Johnson).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startMar 2010
- Primary completionApr 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sauflon Pharmaceuticals Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Philip Morgan, PhD, Principal investigator, MCOptom FAAO FBCLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01392937
- Sponsor's protocol ID
- S09-469
- Status last verified
- Jul 2011
- First submitted
- 6 Jul 2011
- Last updated
- 13 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Performance of the All-in-One Light Multi-purpose Care Regimen for Silicone Hydrogel Contact Lenses
- ClinicalTrials.gov ID
- NCT01392937
- Acronym / sponsor ID
- S09-469
- Conditions
- Healthy
- Keywords
- AIOL, multipurpose solution, silicone hydrogel lenses, The safety and efficacy of the All-in-One Light multipurpose care regimen by comparison with the Aquify care regimen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Sauflon Pharmaceuticals LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 13 Jul 2011 (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.
A clinical trial was conducted to assess the safety and acceptability of the Sauflon Multipurpose Solution when used with four different silicone hydrogel contact lens brands and one conventional hydrogel control lens was conducted over a period of two months, with a control group using Ciba Vision Aquify Multi- Purpose Solution. The study was conducted at six investigator sites and a total of 257 subjects were enrolled. The results of this study showed the safety, acceptability and substantial equivalence of the Sauflon Multipurpose Solution to the predicate device for its intended use.
Detailed description
1.1 Study characteristics This study evaluated the safety and efficacy of the All-in-One Light multipurpose care regimen (Sauflon Pharmaceuticals Limited) by comparison with the Aquify care regimen(Ciba Vision Inc.). Each subject used one of five different lens brands: Air Optix Aqua(Ciba Vision Inc.), PureVision (Bausch + Lomb Inc.), Biofinity (CooperVision Inc.), Acuvue Advance and Acuvue 2 (both Johnson \& Johnson).
The key study features were as follows:
- Two months duration.
- Six investigator sites.
- Daily wear soft (hydrophilic) contact lenses, replaced on a two-weekly basis: Air Optix Aqua, PureVision, Biofinity, Acuvue Advance and Acuvue 2; with one of two care regimens: All-in-One Light and Aquify.
- A total of 257 subjects were enrolled, and 256 subjects accounting for 512 eyes were dispensed lenses. This group was randomized into 173 test subjects (346 eyes) and 83 control subjects (166 eyes).
- Of the 173 test subjects, 163 (94.2%) completed two months of use. Of the 83 control subjects, 73 (88.0%) completed two months of use.
- No eyes remained active at the end of the study.
- There were no adverse reactions. 1.2 Study period The study was conducted over two months of wear. Subjects were examined initially, and at three follow-up visits after two weeks, one month and two months. Study visits commenced on March 29, 2010 and were completed on March 11, 2011.
1.3 Demographics Six investigator sites dispensed 173 test subjects (346 eyes) who used All-in-One Light as their care regimen during the work. Also dispensed were 83 control subjects (166 eyes)who used Aquify as their care regimen during the work. All recruited subjects were existing contact lenses wearers.
Of the 173 test subjects, 163 (94.2%) completed two months of use and ten (5.8%) were discontinued. Of the 83 control subjects, 73 (88.0%) completed two months of use and ten (12.2%) were discontinued.
The enrolled control group was made up of 51 females (61%) and 32 males (39%) with an age range from 18 to 67 years (mean 36.7 years). The enrolled test group was composed of 117 females (67%) and 57 males (33%) with an age range from 18 to 65 years (mean 34.1 years). One subject (female, age 45 years) was enrolled and assigned to the test group but was not dispensed lenses.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| All-in-One Light multipurpose | Active comparator | Device: All-in-One Light multipurposeUsed All in One light multipurpose with one of five different lens brands: Air Optix Aqua(Ciba Vision Inc.), PureVision (Bausch + Lomb Inc.), Biofinity (CooperVision Inc.), Acuvue Advance and Acuvue 2 (both Johnson \& Johnson). |
| Aquify care | Active comparator | Device: Aquify careUse Aquify care with one of five different lens brands: Air Optix Aqua(Ciba Vision Inc.), PureVision (Bausch + Lomb Inc.), Biofinity (CooperVision Inc.), Acuvue Advance and Acuvue 2 (both Johnson \& Johnson). |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects will only be eligible for the study if:
Key exclusion criteria (10 listed)
- Subjects will not be eligible if:
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 |
|---|---|---|
| All-in-One Light multipurposeThe study was conducted over two months of wear. Subjects were examined initially, and at three follow-up visits after two weeks, one month and two months. | Device | All-in-One Light multipurpose |
| Aquify careThe study was conducted over two months of wear. Subjects were examined initially, and at three follow-up visits after two weeks, one month and two months. | Device | Aquify care |
Primary outcome
Overall subjective acceptance.
Time frame: 2 months
The safety and efficacy of the All-in-One Light multipurpose care regimen (Sauflon Pharmaceuticals Limited) by comparison with the Aquify care regimen(Ciba Vision Inc.). Each subject used one of five different lens brands: Air Optix Aqua(Ciba Vision Inc.), PureVision (Bausch + Lomb Inc.), Biofinity (CooperVision Inc.), Acuvue Advance and Acuvue 2 (both Johnson \& Johnson).
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 13 Jul 2011.
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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.
Philip Morgan, PhD principal investigator
MCOptom FAAO FBCLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing All-in-One Light multipurpose and Aquify care in people with Healthy, run by Sauflon Pharmaceuticals 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 8 inclusion and 10 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 13 Jul 2011. 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. 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?
Overall subjective acceptance. (time frame: 2 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 13 Jul 2011.