Ocular ComfortNCT01423773
Ocular Comfort and OCT Observation of Post Lens Clearance and Ocular Tissue Compression
A study testing Lotrafilcon A test contact lens and Ultra-High Resolution Optical Coherence Tomographer (OCT) in people with Ocular Comfort, run by CIBA VISION at 1 site in United States.
Trial summary
The purpose of this study was to compare the fit and comfort of two types of contact lenses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Comfort
- What is being tested?
- Lotrafilcon A test contact lens and Ultra-High Resolution Optical Coherence Tomographer (OCT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Dec 2011
- 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
- Be of legal age of consent and sign Informed Consent document.
- Normal binocularity.
- Be able to wear soft contact lenses.
- Willing to comply with the wear and study visit schedule.
- Spherical contact lens prescription within 0.50 diopter of the available lens powers.
- Spectacle cylinder less than or equal to 1.50 diopter.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Eye injury or surgery within twelve weeks of enrollment.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Currently enrolled in any clinical trial.
- Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions as determined by the investigator.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
McKnight Building, Bascom Palmer Eye Institute
Miami, Florida, 33136
About this study
The purpose of this study was to compare the fit and comfort of two types of contact lenses.
Read the detailed description
The relationship between ocular comfort and the Optical Coherence Tomography (OCT) measurements of post lens clearance and ocular tissue compression was studied.
- Conditions
- Ocular Comfort
- Being tested
- Lotrafilcon A test contact lens, Lotrafilcon A control contact lens, Ultra-High Resolution Optical Coherence Tomographer (OCT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lotrafilcon A test contact lensDevice
Silicone hydrogel single vision, soft contact lens with alternate parameters
Lotrafilcon A control contact lensDevice
Also called Night&Day
Silicone hydrogel single vision, soft contact lens
Ultra-High Resolution Optical Coherence Tomographer (OCT)Device
Investigational, nonsignificant risk device for measuring post lens clearance and ocular tissue compression during contact lens wear
| Study group | Role | What they receive |
|---|---|---|
| Lotrafilcon A test/lotrafilcon A control | Other | Lotrafilcon A test contact lens worn first, with lotrafilcon A control contact lens worn second. Each product worn bilaterally for two days as follows: 20 minutes on Day 1 and 10 hours on Day 2. Receives: Device: Lotrafilcon A test contact lens; Device: Lotrafilcon A control contact lens; Device: Ultra-High Resolution Optical Coherence Tomographer (OCT) |
| Lotrafilcon A control/lotrafilcon A test | Other | Lotrafilcon A control contact lens worn first, with lotrafilcon A test contact lens worn second. Each product worn bilaterally for two days as follows: 20 minutes on Day 1 and 10 hours on Day 2. Receives: Device: Lotrafilcon A test contact lens; Device: Lotrafilcon A control contact lens; Device: Ultra-High Resolution Optical Coherence Tomographer (OCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final Comfort
Comfort was assessed by the participant on a Visual Analog Scale of 0 to 100, where 0=Extremely Uncomfortable ("My eyes are in pain. I cannot tolerate my lenses") and 100=Extremely Comfortable ("My eyes feel GREAT, better than normal. I cannot feel my lenses").
Measured: Day 2, Hour 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2011
- Study completionDec 2011
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 Ocular ComfortStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- CIBA VISION
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bascom Palmer Eye Institute
- Responsible party
- Sponsor
- Investigators
- Jianhua Wang, MD, PhD, Principal investigator, Bascom Palmer Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423773
- Sponsor's protocol ID
- P-367-C-800
- Status last verified
- Nov 2012
- First submitted
- 25 Aug 2011
- Last updated
- 28 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Comfort and OCT Observation of Post Lens Clearance and Ocular Tissue Compression
- ClinicalTrials.gov ID
- NCT01423773
- Acronym / sponsor ID
- P-367-C-800
- Conditions
- Ocular Comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- CIBA VISIONIndustry (pharma, biotech, devices)
- Collaborators
- Bascom Palmer Eye Institute
- Study start
- Aug 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 26 Aug 2011 (estimated)
- Results
- Posted 21 Dec 2012
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 compare the fit and comfort of two types of contact lenses.
Detailed description
The relationship between ocular comfort and the Optical Coherence Tomography (OCT) measurements of post lens clearance and ocular tissue compression was studied.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lotrafilcon A test/lotrafilcon A control | Other | Device: Lotrafilcon A test contact lens, Device: Lotrafilcon A control contact lens, Device: Ultra-High Resolution Optical Coherence Tomographer (OCT)Lotrafilcon A test contact lens worn first, with lotrafilcon A control contact lens worn second. Each product worn bilaterally for two days as follows: 20 minutes on Day 1 and 10 hours on Day 2. |
| Lotrafilcon A control/lotrafilcon A test | Other | Device: Lotrafilcon A test contact lens, Device: Lotrafilcon A control contact lens, Device: Ultra-High Resolution Optical Coherence Tomographer (OCT)Lotrafilcon A control contact lens worn first, with lotrafilcon A test contact lens worn second. Each product worn bilaterally for two days as follows: 20 minutes on Day 1 and 10 hours on Day 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be of legal age of consent and sign Informed Consent document.
- Normal binocularity.
- Be able to wear soft contact lenses.
- Willing to comply with the wear and study visit schedule.
- Spherical contact lens prescription within 0.50 diopter of the available lens powers.
Key exclusion criteria (5 listed)
- Eye injury or surgery within twelve weeks of enrollment.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Currently enrolled in any clinical trial.
- Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions as determined by the investigator.
- Other protocol-defined exclusion criteria may apply.
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 |
|---|---|---|
| Lotrafilcon A test contact lensSilicone hydrogel single vision, soft contact lens with alternate parameters | Device | Lotrafilcon A control/lotrafilcon A test, Lotrafilcon A test/lotrafilcon A control |
| Lotrafilcon A control contact lensAlso: Night&DaySilicone hydrogel single vision, soft contact lens | Device | Lotrafilcon A control/lotrafilcon A test, Lotrafilcon A test/lotrafilcon A control |
| Ultra-High Resolution Optical Coherence Tomographer (OCT)Investigational, nonsignificant risk device for measuring post lens clearance and ocular tissue compression during contact lens wear | Device | Lotrafilcon A control/lotrafilcon A test, Lotrafilcon A test/lotrafilcon A control |
Primary outcome
Final Comfort
Time frame: Day 2, Hour 10
Comfort was assessed by the participant on a Visual Analog Scale of 0 to 100, where 0=Extremely Uncomfortable ("My eyes are in pain. I cannot tolerate my lenses") and 100=Extremely Comfortable ("My eyes feel GREAT, better than normal. I cannot feel my lenses").
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jianhua Wang, MD, PhD principal investigator
Bascom Palmer Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lotrafilcon A test contact lens and Ultra-High Resolution Optical Coherence Tomographer (OCT) in people with Ocular Comfort, run by CIBA VISION 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 7 inclusion and 5 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 28 Jun 2013. 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 21 Dec 2012). 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?
Final Comfort (time frame: Day 2, Hour 10). 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 28 Jun 2013.