Contact Lens ComplicationNCT02298400
A Clinical Study Comparing the Comfort of Three Commercially Available Contact Lenses
A study testing Acuvue® Oasys® Lenses (senofilcon A), 30-Day Bausch + Lomb PureVision (balafilcon A) and Clariti® 1-Day (Somofilcon A) in people with Contact Lens Complication, run by ORA, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to compare the comfort of three commercially available contact lenses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contact Lens Complication
- What is being tested?
- Acuvue® Oasys® Lenses (senofilcon A), 30-Day Bausch + Lomb PureVision (balafilcon A) and Clariti® 1-Day (Somofilcon A)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Sep 2014
- 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
- Be at least 18 years old
- Have provided written informed consent
- Have discomfort when wearing contact lenses
Who cannot join
- Have an active ocular infection or significant slit lamp findings
- Participated in any other studies in the past 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Andover Eye Associates
Andover, Massachusetts, 01810
About this study
Official title: A Single-Center, Cross-over, Pilot Study Evaluating Acuvue® Oasys® Lenses (Senofilcon A), 30-Day Bausch + Lomb PureVision (Balafilcon A), and Clariti® 1-Day (Somofilcon A) Lenses, for Their Impact on Ocular Discomfort Induced by Exposure to the Turbo Controlled Adverse Environment™
The purpose of this study is to compare the comfort of three commercially available contact lenses.
- Conditions
- Contact Lens Complication
- Being tested
- Acuvue® Oasys® Lenses (senofilcon A), 30-Day Bausch + Lomb PureVision (balafilcon A), Clariti® 1-Day (Somofilcon A)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acuvue® Oasys® Lenses (senofilcon A)Device
Contact lenses placed in each eye during the day for about 8 hours
30-Day Bausch + Lomb PureVision (balafilcon A)Device
Contact lenses placed in each eye during the day for about 8 hours
Clariti® 1-Day (Somofilcon A)Device
Contact lenses placed in each eye during the day for about 8 hours
| Study group | Role | What they receive |
|---|---|---|
| Acuvue®Oasys® Lenses(senofilcon A) | Active comparator | Acuvue® Oasys® Lenses (senofilcon A) contact lenses Receives: Device: Acuvue® Oasys® Lenses (senofilcon A); Device: 30-Day Bausch + Lomb PureVision (balafilcon A); Device: Clariti® 1-Day (Somofilcon A) |
| Bausch + Lomb PureVision (balafilcon A) | Active comparator | 30-Day Bausch + Lomb PureVision (balafilcon A) contact lenses Receives: Device: Acuvue® Oasys® Lenses (senofilcon A); Device: 30-Day Bausch + Lomb PureVision (balafilcon A); Device: Clariti® 1-Day (Somofilcon A) |
| Clariti® 1-Day (Somofilcon A) | Active comparator | Clariti® 1-Day (Somofilcon A) contact lenses Receives: Device: Acuvue® Oasys® Lenses (senofilcon A); Device: 30-Day Bausch + Lomb PureVision (balafilcon A); Device: Clariti® 1-Day (Somofilcon A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contact lens wear comfort, as assessed by subject reported symptoms in diaries.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2014
- Study completionSep 2014
Why it stopped: Study terminated by Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact Lens ComplicationStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ORA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298400
- Sponsor's protocol ID
- 14-270-0001
- Status last verified
- Apr 2024
- First submitted
- 17 Nov 2014
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Cross-over, Pilot Study Evaluating Acuvue® Oasys® Lenses (Senofilcon A), 30-Day Bausch + Lomb PureVision (Balafilcon A), and Clariti® 1-Day (Somofilcon A) Lenses, for Their Impact on Ocular Discomfort Induced by Exposure to the Turbo Controlled Adverse Environment™
- ClinicalTrials.gov ID
- NCT02298400
- Acronym / sponsor ID
- 14-270-0001
- Conditions
- Contact Lens Complication
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study terminated by Sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ORA, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2014 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 24 Nov 2014 (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 comfort of three commercially available contact lenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acuvue®Oasys® Lenses(senofilcon A) | Active comparator | Device: Acuvue® Oasys® Lenses (senofilcon A), Device: 30-Day Bausch + Lomb PureVision (balafilcon A), Device: Clariti® 1-Day (Somofilcon A)Acuvue® Oasys® Lenses (senofilcon A) contact lenses |
| Bausch + Lomb PureVision (balafilcon A) | Active comparator | Device: Acuvue® Oasys® Lenses (senofilcon A), Device: 30-Day Bausch + Lomb PureVision (balafilcon A), Device: Clariti® 1-Day (Somofilcon A)30-Day Bausch + Lomb PureVision (balafilcon A) contact lenses |
| Clariti® 1-Day (Somofilcon A) | Active comparator | Device: Acuvue® Oasys® Lenses (senofilcon A), Device: 30-Day Bausch + Lomb PureVision (balafilcon A), Device: Clariti® 1-Day (Somofilcon A)Clariti® 1-Day (Somofilcon A) contact lenses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be at least 18 years old
- Have provided written informed consent
- Have discomfort when wearing contact lenses
Key exclusion criteria (2 listed)
- Have an active ocular infection or significant slit lamp findings
- Participated in any other studies in the past 30 days
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 |
|---|---|---|
| Acuvue® Oasys® Lenses (senofilcon A)Contact lenses placed in each eye during the day for about 8 hours | Device | Acuvue®Oasys® Lenses(senofilcon A), Bausch + Lomb PureVision (balafilcon A), Clariti® 1-Day (Somofilcon A) |
| 30-Day Bausch + Lomb PureVision (balafilcon A)Contact lenses placed in each eye during the day for about 8 hours | Device | Acuvue®Oasys® Lenses(senofilcon A), Bausch + Lomb PureVision (balafilcon A), Clariti® 1-Day (Somofilcon A) |
| Clariti® 1-Day (Somofilcon A)Contact lenses placed in each eye during the day for about 8 hours | Device | Acuvue®Oasys® Lenses(senofilcon A), Bausch + Lomb PureVision (balafilcon A), Clariti® 1-Day (Somofilcon A) |
Primary outcome
Contact lens wear comfort, as assessed by subject reported symptoms in diaries.
Time frame: 1 week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
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 Acuvue® Oasys® Lenses (senofilcon A), 30-Day Bausch + Lomb PureVision (balafilcon A) and Clariti® 1-Day (Somofilcon A) in people with Contact Lens Complication, run by ORA, Inc. 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 2 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: withdrawn, as of the sponsor's last update on 25 Apr 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Contact lens wear comfort, as assessed by subject reported symptoms in diaries. (time frame: 1 week). 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 25 Apr 2024.