Contact LensesNCT00940459
Subjective and Conjunctival Response to Edge Design of Different Silicone Hydrogels
A study testing Senofilcon A contact lens (Acuvue Oasys), Comfilcon A contact lens (Biofinity) and Lotrafilcon B contact lens (Air Optix) in people with Contact Lenses, run by Alcon Research at 1 site in United Kingdom.
Trial summary
The purpose of this study was to evaluate the effect of different contact lens edge designs on the circumlimbal conjunctiva. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contact Lenses
- What is being tested?
- Senofilcon A contact lens (Acuvue Oasys), Comfilcon A contact lens (Biofinity) and Lotrafilcon B contact lens (Air Optix)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2009to Sep 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum age of 18 years old
- Adapted contact lens wearer
- Sign informed consent
- Normal eyes with the exception of the need for visual correction
- Astigmatism less than or equal to -0.75 diopter
- Spherical prescription range between -10.00 and +6.00 diopters
- Other protocol-defined inclusion criteria may apply
Who cannot join
- Any known sensitivity to the test articles used in the study
- Monocular vision
- Lid or conjunctival infections or abnormalities
- Conjunctival staining greater than Grade 1
- Corneal staining greater than Grade 2
- Corneal edema or opacifications
Show all 21Show fewer
- Aphakia
- Any previous corneal surgery
- Iritis
- Recent significant changes in visual acuity
- Ocular disease that contraindicates contact lens wear
- Tarsal abnormalities greater than Grade 2
- Any ophthalmic medication
- Any systemic medication or condition that might affect the subject's participation in the study
- Chronic upper respiratory infections or colds
- Pregnancy or planning to become pregnant
- Lactation
- Seasonal allergies
- Known infections or immunosuppressive disease
- Participation in other studies
- Other protocol-defined exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to evaluate the effect of different contact lens edge designs on the circumlimbal conjunctiva.
- Conditions
- Contact Lenses
- Being tested
- Senofilcon A contact lens (Acuvue Oasys), Comfilcon A contact lens (Biofinity), Lotrafilcon B contact lens (Air Optix), Balafilcon A contact lens (PureVision), Etafilcon A contact lens (Acuvue 2)
- Keywords
- contact lenses, conjunctival staining, contact lens wear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Senofilcon A contact lens (Acuvue Oasys)Device
Also called ACUVUE® OASYS™
Silicone hydrogel contact lens CE-marked for the intended usage.
Comfilcon A contact lens (Biofinity)Device
Also called Biofinity®
Silicone hydrogel contact lens CE-marked for the intended usage.
Lotrafilcon B contact lens (Air Optix)Device
Also called Air Optix®
Silicone hydrogel contact lens CE-marked for the intended usage.
Balafilcon A contact lens (PureVision)Device
Also called PureVision®
Silicone hydrogel contact lens CE-marked for the intended usage.
Etafilcon A contact lens (Acuvue 2)Device
Also called ACUVUE® 2
Hydrogel contact lens CE-marked for the intended usage.
Contact lens care system (EasySept)Device
Also called EasySept
Contact lens care system CE-marked for the intended usage.
| Study group | Role | What they receive |
|---|---|---|
| Acuvue Oasys | Experimental | One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each. Receives: Device: Senofilcon A contact lens (Acuvue Oasys); Device: Contact lens care system (EasySept) |
| Biofinity | Experimental | One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each. Receives: Device: Comfilcon A contact lens (Biofinity); Device: Contact lens care system (EasySept) |
| Air Optix | Experimental | One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each. Receives: Device: Lotrafilcon B contact lens (Air Optix); Device: Contact lens care system (EasySept) |
| PureVision | Experimental | One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each. Receives: Device: Balafilcon A contact lens (PureVision); Device: Contact lens care system (EasySept) |
| Acuvue 2 | Active comparator | One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each. Receives: Device: Etafilcon A contact lens (Acuvue 2); Device: Contact lens care system (EasySept) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circumlimbal Conjunctival Staining (CCS)
Measured: After 10 days of wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contact LensesStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940459
- Sponsor's protocol ID
- M-09-11
- Status last verified
- Jul 2012
- First submitted
- 14 Jul 2009
- Last updated
- 16 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Maissa C, Guillon M, Garofalo RJ. Contact lens-induced circumlimbal staining in silicone hydrogel contact lenses worn on a daily wear basis. Eye Contact Lens. 2012 Jan;38(1):16-26. doi: 10.1097/ICL.0b013e31823bad46.
PubMed 22146704
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subjective and Conjunctival Response to Edge Design of Different Silicone Hydrogels
- ClinicalTrials.gov ID
- NCT00940459
- Acronym / sponsor ID
- M-09-11
- Conditions
- Contact Lenses
- Keywords
- contact lenses, conjunctival staining, contact lens wear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 16 Jul 2009 (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 was to evaluate the effect of different contact lens edge designs on the circumlimbal conjunctiva.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Acuvue Oasys | Experimental | Device: Senofilcon A contact lens (Acuvue Oasys), Device: Contact lens care system (EasySept)One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each. |
| Biofinity | Experimental | Device: Comfilcon A contact lens (Biofinity), Device: Contact lens care system (EasySept)One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each. |
| Air Optix | Experimental | Device: Lotrafilcon B contact lens (Air Optix), Device: Contact lens care system (EasySept)One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each. |
| PureVision | Experimental | Device: Balafilcon A contact lens (PureVision), Device: Contact lens care system (EasySept)One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each. |
| Acuvue 2 | Active comparator | Device: Etafilcon A contact lens (Acuvue 2), Device: Contact lens care system (EasySept)One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Minimum age of 18 years old
- Adapted contact lens wearer
- Sign informed consent
- Normal eyes with the exception of the need for visual correction
- Astigmatism less than or equal to -0.75 diopter
Key exclusion criteria (21 listed)
- Any known sensitivity to the test articles used in the study
- Monocular vision
- Lid or conjunctival infections or abnormalities
- Conjunctival staining greater than Grade 1
- Corneal staining greater than Grade 2
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 |
|---|---|---|
| Senofilcon A contact lens (Acuvue Oasys)Also: ACUVUE® OASYS™Silicone hydrogel contact lens CE-marked for the intended usage. | Device | Acuvue Oasys |
| Comfilcon A contact lens (Biofinity)Also: Biofinity®Silicone hydrogel contact lens CE-marked for the intended usage. | Device | Biofinity |
| Lotrafilcon B contact lens (Air Optix)Also: Air Optix®Silicone hydrogel contact lens CE-marked for the intended usage. | Device | Air Optix |
| Balafilcon A contact lens (PureVision)Also: PureVision®Silicone hydrogel contact lens CE-marked for the intended usage. | Device | PureVision |
| Etafilcon A contact lens (Acuvue 2)Also: ACUVUE® 2Hydrogel contact lens CE-marked for the intended usage. | Device | Acuvue 2 |
| Contact lens care system (EasySept)Also: EasySeptContact lens care system CE-marked for the intended usage. | Device | Acuvue 2, Acuvue Oasys, Air Optix, Biofinity, PureVision |
Primary outcome
Circumlimbal Conjunctival Staining (CCS)
Time frame: After 10 days of wear
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 16 Nov 2016.
- Results publication: PubMed 22146704Maissa C, Guillon M, Garofalo RJ. Contact lens-induced circumlimbal staining in silicone hydrogel contact lenses worn on a daily wear basis. Eye Contact Lens. 2012 Jan;38(1):16-26. doi: 10.1097/ICL.0b013e31823bad46.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Senofilcon A contact lens (Acuvue Oasys), Comfilcon A contact lens (Biofinity) and Lotrafilcon B contact lens (Air Optix) in people with Contact Lenses, run by Alcon Research 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 7 inclusion and 21 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 16 Nov 2016. 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?
Circumlimbal Conjunctival Staining (CCS) (time frame: After 10 days of wear). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00940459, which also lists 1 linked publication.
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 16 Nov 2016.