Corneal DeformityNCT02258139
Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens
A study testing B&L Investigational Contact Lens in people with Corneal Deformity, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
This will be a randomized non-dispensing study comparing the overnight corneal swelling of an eye while wearing no contact lens to the Ultra contract lens. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Corneal Deformity
- What is being tested?
- B&L Investigational Contact Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2014to 11 Dec 2014
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be between 18 and 40 years of age (inclusive)
- Not a current contact lens wearer (have not worn extended wear, and not worn in lenses in 6 months)
- Able to read, comprehend and sign an informed consent
- Willing to comply with the wear and study visit schedule
- Monocular best-corrected distance visual acuity >/-20/25 in each eye
Who cannot join
- Any active corneal infection, disease, injury, inflammation, past surgery, or ocular abnormality which may interfere with contact lens wear
- Systemic or ocular allergies, which might interfere with contact lens wear
- Systemic disease or condition, which might interfere with contact lens wear
- Use of prescription sleep aids or alcohol within 24 hours of study appointment
- Inability to wear contact lenses
- Under 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens
This will be a randomized non-dispensing study comparing the overnight corneal swelling of an eye while wearing no contact lens to the Ultra contract lens.
- Conditions
- Corneal Deformity
- Being tested
- B&L Investigational Contact Lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B&L Investigational Contact LensDevice
The lens used in this study will be supplied by the Sponsor. All subjects will wear a -3.00D lens.
| Study group | Role | What they receive |
|---|---|---|
| Study Group 1 | Experimental | 1st overnight visit with no contact lens; 2nd overnight visit randomized to either left or right eye for B\&L Investigational Contact Lens Receives: Device: B&L Investigational Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Central Corneal Thickness
Percent change in central corneal thickness from evening to morning (after 8 hours with lid closed)
Measured: 8 hours
Secondary outcomes (1)
Time to Restore Central Corneal Thickness
Time (hours) to restore central corneal thickness to its baseline value after lens removal
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2014 (estimated)
- Study start3 Nov 2014
- Primary completion11 Dec 2014
- Study completion11 Dec 2014
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 Corneal DeformityStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Steffen, OD, MS, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258139
- Sponsor's protocol ID
- 14-002
- Status last verified
- Sep 2020
- First submitted
- 3 Oct 2014
- Last updated
- 14 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens
- ClinicalTrials.gov ID
- NCT02258139
- Acronym / sponsor ID
- 14-002
- Conditions
- Corneal Deformity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2014 (actual)
- Primary completion
- 11 Dec 2014 (actual)
- Study completion
- 11 Dec 2014 (actual)
- First posted
- 7 Oct 2014 (estimated)
- Results
- Posted 14 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a randomized non-dispensing study comparing the overnight corneal swelling of an eye while wearing no contact lens to the Ultra contract lens.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group 1 | Experimental | Device: B&L Investigational Contact Lens1st overnight visit with no contact lens; 2nd overnight visit randomized to either left or right eye for B\&L Investigational Contact Lens |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Be between 18 and 40 years of age (inclusive)
- Not a current contact lens wearer (have not worn extended wear, and not worn in lenses in 6 months)
- Able to read, comprehend and sign an informed consent
- Willing to comply with the wear and study visit schedule
- Monocular best-corrected distance visual acuity >/-20/25 in each eye
Key exclusion criteria (6 listed)
- Any active corneal infection, disease, injury, inflammation, past surgery, or ocular abnormality which may interfere with contact lens wear
- Systemic or ocular allergies, which might interfere with contact lens wear
- Systemic disease or condition, which might interfere with contact lens wear
- Use of prescription sleep aids or alcohol within 24 hours of study appointment
- Inability to wear contact lenses
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 |
|---|---|---|
| B&L Investigational Contact LensThe lens used in this study will be supplied by the Sponsor. All subjects will wear a -3.00D lens. | Device | Study Group 1 |
Primary outcome
Percent Change in Central Corneal Thickness
Time frame: 8 hours
Percent change in central corneal thickness from evening to morning (after 8 hours with lid closed)
1 secondary outcome
Time to Restore Central Corneal Thickness
Time frame: 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- 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.
Robert Steffen, OD, MS 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 B&L Investigational Contact Lens in people with Corneal Deformity, 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 5 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 14 Sep 2020. 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 14 Sep 2020). 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?
Percent Change in Central Corneal Thickness (time frame: 8 hours). 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 14 Sep 2020.