Corneal SwellingNCT02328937
Central Corneal Swelling With Silicone Hydrogel Materials
A study testing etafilcon A, lotrafilcon B and comfilcon A in people with Corneal Swelling, run by Johnson & Johnson Vision Care, Inc. at 1 site in United States.
Trial summary
This is a prospective, single site, unmasked, cross-over study with three silicone hydrogel contact lenses comparing central corneal swelling. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Corneal Swelling
- What is being tested?
- etafilcon A, lotrafilcon B and comfilcon A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Apr 2015
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The participant must be at leat 18 years old or older and no greater than 65 years old. Children younger than18 will likely no be able to come back and forth to the clinic during the typical work week as outlined in the above (due to school schedules) and thus not be able to adhere to the protocol.
- The participant must be a current soft contact lens wearer who routinely wears lenses at least 6-8 hours per day and at least 4 days per week for at least the past 3 months.
- Refraction suitable for spherical soft contact lens powers between -1.00 and -6.00 D the participant must be correctable to 20/30 or better at distance with both eyes with dispensed contact lenses.
- The participant must be free of any active anterior segment disorders that would preclude safe contact lens wear. Active anterior segment disorders and evidence of central microbial keratitis are not allowed. However, evidence of past CLPU will be allowed so long as no more than 3 such scars are detected bilaterally. Evidence of more than 3 CLPU-like scars places excessive risk on the participant for subsequent CIE.
- The participant must be correctable to 20/25 or better in each eye with spectacles. Amblyopia will be excluded.
- Flat and steep corneal curvatures from keratometry readings must be between 39.00 and 48.50 D, respectively. Corneal curvatures outside this range may be indicative of a disease state, and the participants are not expected to comfortably wear the study lenses.
- The participant must own or agree to purchase a pair of spectacles that can be worn when lenses are removed, during the washout periods, or in case of ocular discomfort or emergency.
Who cannot join
- The participant has worn rigid gas permeable contact lenses within the last 30 days or PMMA lenses within the past 12 months. These lenses can transiently alter the corneal shape and influence the fitting of soft contact lenses or alter endothelial cell morphology.
- The participant has an immunocompromising disease or any other systemic disease that in the investigator's opinion will affect ocular health or increase risk during daily contact lens wear.
- The participant is taking any medication that in the investigator's opinion will affect ocular physiology or study participation.
- The participant has an ocular disease or condition such as aphakia, clinically significant corneal dystrophies, corneal edema, external ocular infection, iritis, or had any anterior segment surgery.
- The participant is taking any ocular medications. If a participant was previous taking any ocular medications, the medications must have been discontinued at least 2 weeks prior to enrollment.
- The participant must have less than or equal to grade 2 on any of the slit lamp observations of: upper tarsal papilla, corneal staining, corneal neovascularization, conjunctival injection, and lid erythema or scales.
- The participant is currently pregnant or lactating. Participant who become pregnant during the study will be discontinued.
- An employee or member of the UHCMC Eye Institute or a family member of any study personnel.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Daily Wear Central Corneal Swelling With Etafilcon A and 2 Silicone Hydrogel Materials
This is a prospective, single site, unmasked, cross-over study with three silicone hydrogel contact lenses comparing central corneal swelling.
- Conditions
- Corneal Swelling
- Being tested
- etafilcon A, lotrafilcon B, comfilcon A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etafilcon ADevice
Also called Investigational Soft Contact Lens -
spherical hydrophilic soft contact lens worn in a daily wear modality
lotrafilcon BDevice
comfilcon ADevice
| Study group | Role | What they receive |
|---|---|---|
| etafilcon A/lotrafilcon B/comfilcon A | Active comparator | Subjects that were randomized to receive the etafilcon A lens 1st, the lotrafilcon B lens 2nd and the comfilcon A lens 3rd. Receives: Device: etafilcon A; Device: lotrafilcon B; Device: comfilcon A |
| etafilcon A/comfilcon A/lotrafilcon B | Active comparator | Subjects that were randomized to receive the etafilcon A lens 1st, the comfilcon A lens 2nd and the lotrafilcon B lens 3rd. Receives: Device: etafilcon A; Device: lotrafilcon B; Device: comfilcon A |
| comfilcon A/etafilcon A/lotrafilcon B | Active comparator | Subjects that were randomized to receive the comfilcon A lens 1st, the etafilcon A lens 2nd and the lotrafilcon B lens 3rd. Receives: Device: etafilcon A; Device: lotrafilcon B; Device: comfilcon A |
| comfilcon A/lotrafilcon B/etafilcon A | Active comparator | Subjects that were randomized to receive the comfilcon A lens 1st, the lotrafilcon B lens 2nd and the etafilcon A lens 3rd. Receives: Device: etafilcon A; Device: lotrafilcon B; Device: comfilcon A |
| lotrafilcon B/etafilcon A/comfilcon A | Active comparator | Subjects that were randomized to receive the lotrafilcon B lens 1st, the etafilcon A lens 2nd and the comfilcon A lens 3rd. Receives: Device: etafilcon A; Device: lotrafilcon B; Device: comfilcon A |
| lotrafilcon B/comfilcon A/etafilcon A | Active comparator | Subjects that were randomized to receive the lotrafilcon B lens 1st, the comfilcon A lens 2nd and the etafilcon A lens 3rd. Receives: Device: etafilcon A; Device: lotrafilcon B; Device: comfilcon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Corneal Swelling
Corneal swelling measurements were taken in the right eye during slit lamp evaluations, 6-8 hours post lens insertion. The average corneal swelling per lens was reported.
Measured: 6-8 Hours Post lens insertion
Secondary outcomes (1)
Limbal Redness
Limbal redness was assessed in both eyes using a slit lamp, 6-8 hours post lens insertion. Redness was assessed in 4 regions of the eye (nasal, temporal, inferior and superior) and was graded with a 5-point scale (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). For each region (nasal, temporal, inferior and superior) the average grade was calculated by lens. The Total Grade was then calculated by summing all the average grade for each region. The regional average grade ranges from 0 to 4. The total Grade ranges from 0 to 16.
Measured: 6-8 hours post lens insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionApr 2015
- Study completionApr 2015
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 SwellingStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328937
- Sponsor's protocol ID
- CR-5550
- Status last verified
- Dec 2016
- First submitted
- 3 Dec 2014
- Last updated
- 19 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Wear Central Corneal Swelling With Etafilcon A and 2 Silicone Hydrogel Materials
- ClinicalTrials.gov ID
- NCT02328937
- Acronym / sponsor ID
- CR-5550
- Conditions
- Corneal Swelling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 31 Dec 2014 (estimated)
- Results
- Posted 30 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, single site, unmasked, cross-over study with three silicone hydrogel contact lenses comparing central corneal swelling.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| etafilcon A/lotrafilcon B/comfilcon A | Active comparator | Device: etafilcon A, Device: lotrafilcon B, Device: comfilcon ASubjects that were randomized to receive the etafilcon A lens 1st, the lotrafilcon B lens 2nd and the comfilcon A lens 3rd. |
| etafilcon A/comfilcon A/lotrafilcon B | Active comparator | Device: etafilcon A, Device: lotrafilcon B, Device: comfilcon ASubjects that were randomized to receive the etafilcon A lens 1st, the comfilcon A lens 2nd and the lotrafilcon B lens 3rd. |
| comfilcon A/etafilcon A/lotrafilcon B | Active comparator | Device: etafilcon A, Device: lotrafilcon B, Device: comfilcon ASubjects that were randomized to receive the comfilcon A lens 1st, the etafilcon A lens 2nd and the lotrafilcon B lens 3rd. |
| comfilcon A/lotrafilcon B/etafilcon A | Active comparator | Device: etafilcon A, Device: lotrafilcon B, Device: comfilcon ASubjects that were randomized to receive the comfilcon A lens 1st, the lotrafilcon B lens 2nd and the etafilcon A lens 3rd. |
| lotrafilcon B/etafilcon A/comfilcon A | Active comparator | Device: etafilcon A, Device: lotrafilcon B, Device: comfilcon ASubjects that were randomized to receive the lotrafilcon B lens 1st, the etafilcon A lens 2nd and the comfilcon A lens 3rd. |
| lotrafilcon B/comfilcon A/etafilcon A | Active comparator | Device: etafilcon A, Device: lotrafilcon B, Device: comfilcon ASubjects that were randomized to receive the lotrafilcon B lens 1st, the comfilcon A lens 2nd and the etafilcon A lens 3rd. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The participant must be at leat 18 years old or older and no greater than 65 years old. Children younger than18 will likely no be able to come back and forth to the clinic during the typical work week as outlined in the above (due to school schedules) and thus not be able to adhere to the protocol.
- The participant must be a current soft contact lens wearer who routinely wears lenses at least 6-8 hours per day and at least 4 days per week for at least the past 3 months.
- Refraction suitable for spherical soft contact lens powers between -1.00 and -6.00 D the participant must be correctable to 20/30 or better at distance with both eyes with dispensed contact lenses.
- The participant must be free of any active anterior segment disorders that would preclude safe contact lens wear. Active anterior segment disorders and evidence of central microbial keratitis are not allowed. However, evidence of past CLPU will be allowed so long as no more than 3 such scars are detected bilaterally. Evidence of more than 3 CLPU-like scars places excessive risk on the participant for subsequent CIE.
- The participant must be correctable to 20/25 or better in each eye with spectacles. Amblyopia will be excluded.
Key exclusion criteria (8 listed)
- The participant has worn rigid gas permeable contact lenses within the last 30 days or PMMA lenses within the past 12 months. These lenses can transiently alter the corneal shape and influence the fitting of soft contact lenses or alter endothelial cell morphology.
- The participant has an immunocompromising disease or any other systemic disease that in the investigator's opinion will affect ocular health or increase risk during daily contact lens wear.
- The participant is taking any medication that in the investigator's opinion will affect ocular physiology or study participation.
- The participant has an ocular disease or condition such as aphakia, clinically significant corneal dystrophies, corneal edema, external ocular infection, iritis, or had any anterior segment surgery.
- The participant is taking any ocular medications. If a participant was previous taking any ocular medications, the medications must have been discontinued at least 2 weeks prior to enrollment.
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 |
|---|---|---|
| etafilcon AAlso: Investigational Soft Contact Lens -spherical hydrophilic soft contact lens worn in a daily wear modality | Device | comfilcon A/etafilcon A/lotrafilcon B, comfilcon A/lotrafilcon B/etafilcon A, etafilcon A/comfilcon A/lotrafilcon B, etafilcon A/lotrafilcon B/comfilcon A, lotrafilcon B/comfilcon A/etafilcon A, lotrafilcon B/etafilcon A/comfilcon A |
| lotrafilcon B | Device | comfilcon A/etafilcon A/lotrafilcon B, comfilcon A/lotrafilcon B/etafilcon A, etafilcon A/comfilcon A/lotrafilcon B, etafilcon A/lotrafilcon B/comfilcon A, lotrafilcon B/comfilcon A/etafilcon A, lotrafilcon B/etafilcon A/comfilcon A |
| comfilcon A | Device | comfilcon A/etafilcon A/lotrafilcon B, comfilcon A/lotrafilcon B/etafilcon A, etafilcon A/comfilcon A/lotrafilcon B, etafilcon A/lotrafilcon B/comfilcon A, lotrafilcon B/comfilcon A/etafilcon A, lotrafilcon B/etafilcon A/comfilcon A |
Primary outcome
Central Corneal Swelling
Time frame: 6-8 Hours Post lens insertion
Corneal swelling measurements were taken in the right eye during slit lamp evaluations, 6-8 hours post lens insertion. The average corneal swelling per lens was reported.
1 secondary outcome
Limbal Redness
Time frame: 6-8 hours post lens insertion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 etafilcon A, lotrafilcon B and comfilcon A in people with Corneal Swelling, run by Johnson & Johnson Vision Care, 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 7 inclusion and 8 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 19 Jun 2018. 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 Jan 2017). 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?
Central Corneal Swelling (time frame: 6-8 Hours Post lens insertion). 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 19 Jun 2018.