HyperopiaNCT01392950
Clinical Study of Clariti Monthly Contact Lens
A study testing Air Optix Aqua and Clariti in people with Hyperopia and Myopia, run by Sauflon Pharmaceuticals Ltd at 1 site in United Kingdom.
Trial summary
A clinical study report follows; this clinical study evaluated the safety and efficacy of SAUFLON CLARITI Soft Silicone Hydrogel Contact Lens with UV Blocker by comparison with Air Optix Aqua silicone hydrogel contact lenses (Ciba Vision Inc.). Read more about this study
- Who is it for?
- Ages 19 to 63 yearsHealthy volunteers can take part
- What is being tested?
- Air Optix Aqua and Clariti
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 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 19 to 63 years
- All sexes
- Healthy volunteers accepted
- 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 6/9 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 range available.
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 have glaucoma (high pressure in the eye), have had cataract surgery or a history of recurring abrasions.
- They have had corneal refractive surgery.
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- They have any corneal distortion resulting from previous hard or rigid lens wear or have 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, M60 1QD
About this study
Official title: Clinical Performance of the Clariti Monthly Contact Lens for Daily Wear
A clinical study report follows; this clinical study evaluated the safety and efficacy of SAUFLON CLARITI Soft Silicone Hydrogel Contact Lens with UV Blocker by comparison with Air Optix Aqua silicone hydrogel contact lenses (Ciba Vision Inc.).
Subjects used OptiFree Replenish solution (Alcon Laboratories Inc.) for daily lens maintenance, care and storage.
Read the detailed description
1.1 Study characteristics This study evaluated the safety and efficacy of Clariti Monthly silicone hydrogel contact lenses (Sauflon Pharmaceuticals Limited) by comparison with Air Optix Aqua silicone hydrogel contact lenses (Ciba Vision Inc.). Subjects used OptiFree Replenish solution(Alcon Laboratories Inc.) for daily lens maintenance, care and storage.
The key study features were as follows:
- Three months duration.
- Seven investigator sites.
- Daily wear soft (hydrophilic) silicone hydrogel contact lenses, replaced on a monthly basis: Clariti Monthly and Air Optix Aqua. OptiFree Replenish was used as a care system by all subjects.
- A total of 95 subjects were enrolled, and 94 subjects accounting for 188 eyes were dispensed lenses. This group was randomized into 64 test subjects (128 eyes)and 30 control subjects (60 eyes).
- Of the 64 test subjects, 56 (87.5%) completed three months of use. Of the 30 control subjects, 29 (96.7%) completed three 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 three months of wear. Subjects were examined initially,and at five follow-up visits after one week, two weeks, four weeks, eight weeks and 12 weeks. Study visits commenced on September 6, 2010 and were completed on March 16, 2011.
1.3 Demographics Seven investigator sites dispensed 64 test subjects (128 eyes) who used Clariti Monthly as their contact lens during the work. Also enrolled were 30 control subjects (60 eyes)who used Air Optix Aqua as their contact lens during the work. All recruited subjects were existing contact lenses wearers.
Of the 64 test subjects, 56 (87.5%) completed three months of use and eight (12.5%)were discontinued. Of the 30 control subjects, 29 (96.7%) completed three months of use and one (3.4%) was discontinued.
The enrolled control group was made up of 22 females (73%) and eight males (27%) with an age range from 19 to 63 years (mean 35.6 years). The enrolled test group was composed of 41 females (63%) and 24 males (37%) with an age range from 17 to 62 years (mean 32.8 years). One ineligible subject (age 17 years) was enrolled and assigned to the test group but was not dispensed lenses.
- Being tested
- Air Optix Aqua, Clariti
- Keywords
- silicone hydrogel contact lenses for daily wear
- Medical subject headings
- Hyperopia, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air Optix AquaDevice
Lenses will be worn on a daily wear basis (ie. removed at night and stored in solution) and worn in the normal way. Lenses will be replaced each month. Lenses should be worn for a minimum of six hours a day, four days a week. The lenses are also to be worn for a minimum of two hours before attending all follow-up visits.
ClaritiDevice
Lenses will be worn on a daily wear basis (ie. removed at night and stored in solution) and worn in the normal way. Lenses will be replaced each month. Lenses should be worn for a minimum of six hours a day, four days a week. The lenses are also to be worn for a minimum of two hours before attending all follow-up visits.
| Study group | Role | What they receive |
|---|---|---|
| Air Optix Aqua | Active comparator | Compare safety and efficacy using OptiFree Replenish solution Receives: Device: Air Optix Aqua |
| Clariti | Active comparator | Compare safety and efficacy of the lens using OptiFree Replenish solution Receives: Device: Clariti |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall subjective acceptance
The results of this study showed the safety, acceptability and substantial equivalence of the Sauflon CLARITI (somofilcon A) Soft Silicone Hydrogel Contact Lens with UV Blocker to the predicate device for its intended use.
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 posted13 Jul 2011 (estimated)
- Study startSep 2010
- Primary completionOct 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 HyperopiaStudies 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
- None (open label)
- Enrolment
- 90 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
- NCT01392950
- Sponsor's protocol ID
- S10-491
- Status last verified
- Jul 2011
- First submitted
- 6 Jul 2011
- Last updated
- 29 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of the Clariti Monthly Contact Lens for Daily Wear
- ClinicalTrials.gov ID
- NCT01392950
- Acronym / sponsor ID
- S10-491
- Keywords
- silicone hydrogel contact lenses for daily wear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sauflon Pharmaceuticals LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Oct 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 study report follows; this clinical study evaluated the safety and efficacy of SAUFLON CLARITI Soft Silicone Hydrogel Contact Lens with UV Blocker by comparison with Air Optix Aqua silicone hydrogel contact lenses (Ciba Vision Inc.).
Subjects used OptiFree Replenish solution (Alcon Laboratories Inc.) for daily lens maintenance, care and storage.
Detailed description
1.1 Study characteristics This study evaluated the safety and efficacy of Clariti Monthly silicone hydrogel contact lenses (Sauflon Pharmaceuticals Limited) by comparison with Air Optix Aqua silicone hydrogel contact lenses (Ciba Vision Inc.). Subjects used OptiFree Replenish solution(Alcon Laboratories Inc.) for daily lens maintenance, care and storage.
The key study features were as follows:
- Three months duration.
- Seven investigator sites.
- Daily wear soft (hydrophilic) silicone hydrogel contact lenses, replaced on a monthly basis: Clariti Monthly and Air Optix Aqua. OptiFree Replenish was used as a care system by all subjects.
- A total of 95 subjects were enrolled, and 94 subjects accounting for 188 eyes were dispensed lenses. This group was randomized into 64 test subjects (128 eyes)and 30 control subjects (60 eyes).
- Of the 64 test subjects, 56 (87.5%) completed three months of use. Of the 30 control subjects, 29 (96.7%) completed three 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 three months of wear. Subjects were examined initially,and at five follow-up visits after one week, two weeks, four weeks, eight weeks and 12 weeks. Study visits commenced on September 6, 2010 and were completed on March 16, 2011.
1.3 Demographics Seven investigator sites dispensed 64 test subjects (128 eyes) who used Clariti Monthly as their contact lens during the work. Also enrolled were 30 control subjects (60 eyes)who used Air Optix Aqua as their contact lens during the work. All recruited subjects were existing contact lenses wearers.
Of the 64 test subjects, 56 (87.5%) completed three months of use and eight (12.5%)were discontinued. Of the 30 control subjects, 29 (96.7%) completed three months of use and one (3.4%) was discontinued.
The enrolled control group was made up of 22 females (73%) and eight males (27%) with an age range from 19 to 63 years (mean 35.6 years). The enrolled test group was composed of 41 females (63%) and 24 males (37%) with an age range from 17 to 62 years (mean 32.8 years). One ineligible subject (age 17 years) was enrolled and assigned to the test group but was not dispensed lenses.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Air Optix Aqua | Active comparator | Device: Air Optix AquaCompare safety and efficacy using OptiFree Replenish solution |
| Clariti | Active comparator | Device: ClaritiCompare safety and efficacy of the lens using OptiFree Replenish solution |
Who may qualify
- Ages
- 19 to 63 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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 |
|---|---|---|
| Air Optix AquaLenses will be worn on a daily wear basis (ie. removed at night and stored in solution) and worn in the normal way. Lenses will be replaced each month. Lenses should be worn for a minimum of six hours a day, four days a week. The lenses are also to be worn for a minimum of two hours before attending all follow-up visits. | Device | Air Optix Aqua |
| ClaritiLenses will be worn on a daily wear basis (ie. removed at night and stored in solution) and worn in the normal way. Lenses will be replaced each month. Lenses should be worn for a minimum of six hours a day, four days a week. The lenses are also to be worn for a minimum of two hours before attending all follow-up visits. | Device | Clariti |
Primary outcome
Overall subjective acceptance
Time frame: 3 months
The results of this study showed the safety, acceptability and substantial equivalence of the Sauflon CLARITI (somofilcon A) Soft Silicone Hydrogel Contact Lens with UV Blocker to the predicate device for its intended use.
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 29 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 Air Optix Aqua and Clariti in people with Hyperopia and Myopia, 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 29 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: 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 29 Jul 2011.