MyopiaNCT01131130
Feasibility of a New Silicone Hydrogel Lens
A study testing Investigational contact lens, Acuvue Oasys Contact Lens and Air Optix Aqua in people with Myopia, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
The objective of this study is to determine the product feasibility of the investigational contact lens (Test) when compared to the currently marketed Acuvue Oasys contact lens (Control) and the Air Optix Aqua contact lens (Control) when worn by adapted wearers of soft contact lenses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- Investigational contact lens, Acuvue Oasys Contact Lens and Air Optix Aqua
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Jun 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participants must have clear central corneas and be free of any anterior segment disorders.
- Participants must be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
- Participants must be myopic and require lens correction from -0.75 D to - 4.75D in each eye.
Who cannot join
- Participants who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
- Participants with any systemic disease affecting ocular health.
- Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- Participants with an active ocular disease or are using any ocular medication.
- Participants who have had any corneal surgery (eg, refractive surgery).
- Participants who are allergic to any component in the study care products.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Lens
The objective of this study is to determine the product feasibility of the investigational contact lens (Test) when compared to the currently marketed Acuvue Oasys contact lens (Control) and the Air Optix Aqua contact lens (Control) when worn by adapted wearers of soft contact lenses.
- Conditions
- Myopia
- Being tested
- Investigational contact lens, Acuvue Oasys Contact Lens, Air Optix Aqua
- Keywords
- Contact lens
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational contact lensDevice
After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.
Acuvue Oasys Contact LensDevice
After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.
Air Optix AquaDevice
After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.
| Study group | Role | What they receive |
|---|---|---|
| Investigational contact lens | Experimental | Bausch \& Lomb Receives: Device: Investigational contact lens |
| Acuvue Oasys Contact Lens | Active comparator | Johnson \& Johnson Lens Receives: Device: Acuvue Oasys Contact Lens |
| Air Optix Aqua | Active comparator | Ciba Vision Receives: Device: Air Optix Aqua |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort Throughout the Day - Test Lens vs. Air Optix Aqua Lens
Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.
Measured: 7 days
Comfort Throughout the Day - Test Lens vs. Acuvue Oasys
Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.
Measured: 7 days
Secondary outcomes (2)
Lens Wettability, Test Lens vs. Acuvue Oasys
Lens wettability was assessed at each visit as Grade 4 - 0, with 4=optimal (100% of anterior surface wettable) and 0=severe (Presence of one or more non-wetting areas > 0.5 mm in size).
Measured: 7 days
Lens Wettability, Test Lens vs. Air Optix Aqua
Lens wettability was assessed at each visit as Grade 4 - 0, with 4=optimal (100% of anterior surface wettable) and 0=severe (Presence of one or more non-wetting areas > 0.5 mm in size).
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MyopiaStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerard Carains, MCOptom, PhD, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131130
- Sponsor's protocol ID
- 655
- Status last verified
- Mar 2014
- First submitted
- 25 May 2010
- Last updated
- 30 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Lens
- ClinicalTrials.gov ID
- NCT01131130
- Acronym / sponsor ID
- 655
- Conditions
- Myopia
- Keywords
- Contact lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 26 May 2010 (estimated)
- Results
- Posted 30 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine the product feasibility of the investigational contact lens (Test) when compared to the currently marketed Acuvue Oasys contact lens (Control) and the Air Optix Aqua contact lens (Control) when worn by adapted wearers of soft contact lenses.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Investigational contact lens | Experimental | Device: Investigational contact lensBausch \& Lomb |
| Acuvue Oasys Contact Lens | Active comparator | Device: Acuvue Oasys Contact LensJohnson \& Johnson Lens |
| Air Optix Aqua | Active comparator | Device: Air Optix AquaCiba Vision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must have clear central corneas and be free of any anterior segment disorders.
- Participants must be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
- Participants must be myopic and require lens correction from -0.75 D to - 4.75D in each eye.
Key exclusion criteria (6 listed)
- Participants who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
- Participants with any systemic disease affecting ocular health.
- Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- Participants with an active ocular disease or are using any ocular medication.
- Participants who have had any corneal surgery (eg, refractive surgery).
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 |
|---|---|---|
| Investigational contact lensAfter one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type. | Device | Investigational contact lens |
| Acuvue Oasys Contact LensAfter one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type. | Device | Acuvue Oasys Contact Lens |
| Air Optix AquaAfter one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type. | Device | Air Optix Aqua |
Primary outcome
Comfort Throughout the Day - Test Lens vs. Air Optix Aqua Lens
Time frame: 7 days
Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.
Comfort Throughout the Day - Test Lens vs. Acuvue Oasys
Time frame: 7 days
Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.
2 secondary outcomes
Lens Wettability, Test Lens vs. Acuvue Oasys
Time frame: 7 days
Lens Wettability, Test Lens vs. Air Optix Aqua
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Myopia
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
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.
Gerard Carains, MCOptom, PhD study director
Bausch & Lomb Incorporated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational contact lens, Acuvue Oasys Contact Lens and Air Optix Aqua in people with Myopia, run by Bausch & Lomb Incorporated at 1 site in United States.
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 3 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 30 Apr 2014. 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 States. 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?
Yes. Results are posted in the registry (first posted 30 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Comfort Throughout the Day - Test Lens vs. Air Optix Aqua Lens (time frame: 7 days). The study lists 2 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 30 Apr 2014.