Corneal SwellingNCT01765972
Open Eye Corneal Swelling With Daily Disposable Contact Lenses and no Lens Wear
A study testing etafilcon A with Lacreon, etafilcon A with Lacreon with print and etafilcon A with print in people with Corneal Swelling, run by Johnson & Johnson Vision Care, Inc. at 1 site in Canada.
Trial summary
The primary purpose of this clinical trial is to evaluate the eye's response to three test soft contact lenses as well as no lens wear, with respect to Corneal Staining. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Corneal Swelling
- What is being tested?
- etafilcon A with Lacreon, etafilcon A with Lacreon with print and etafilcon A with print
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2012to May 2013
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol.
- The subject must be between 18 and 45 years of age.
- The subject must be an adapted soft contact lens wearer in both eyes.
- The subject must be of East or Southeast Asian descent, e.g. ethnic Chinese, Japanese, Korean, Malay, Vietnamese, Indonesian, Filipino, etc. (it is preferred but not required that both the subject's biological parents are East or Southeast Asian ethnicity, by self report).
- The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 D in each eye.
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- The subject's refractive cylinder must be no more than 1.00D in each eye.
- The subject must have best corrected visual acuity of +0.14 logMAR (equivalent to 20/25-2) or better in each eye.
- Subjects must own a wearable pair of spectacles and wear them on the day of the initial visit, during the washout before each phase and during the no lens wear phase.
- The subject must have normal eyes (i.e., no ocular medications or infections of any type).
Who cannot join
- Are currently pregnant or lactating by self report (subjects who become pregnant during the study will be discontinued).
- Have any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- Have any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but may not be limited to, diabetes. hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndromes, xerophthalmia, acne rosacea, Stevens-Johnson syndromes, HIV/AIDS, hepatitis, and tuberculosis.
- Use of any topical medications such aas eye drops or ointments.
- Have entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosion, or aphakia.
- Had any previous, or planned ocular or intraocular surgery (e.g. cataract surgery, radial keratotomy, PRK, LASIK, etc.).
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- Have any grade 2.0 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the Efron classification scale or any other ocular abnormality that may contraindicate contact lens wear.
- Have any known hypersensitivity or allergic reaction to one of the study products.
- Have any ocular infection.
- Have any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- Have participated in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
- Have any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV by self report).
- Currently wear their contact lenses on an extended wear basis.
- Are an employee of the investigational clinic (e.g. Investigator, Coordinator, Technician)
Trial locations and contacts
1 site in 1 country.
About this study
The primary purpose of this clinical trial is to evaluate the eye's response to three test soft contact lenses as well as no lens wear, with respect to Corneal Staining.
- Conditions
- Corneal Swelling
- Being tested
- etafilcon A with Lacreon, etafilcon A with Lacreon with print, etafilcon A with print, Spectacles (habitual)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etafilcon A with LacreonDevice
Also called Test 1
contact lens with Lacreon
etafilcon A with Lacreon with printDevice
Also called Test 2
contact lens with Lacreon and cosmetic print
etafilcon A with printDevice
Also called Test 3
contact lens with print
Spectacles (habitual)Device
Spectacles
| Study group | Role | What they receive |
|---|---|---|
| Test 1/Spectacles/Test 2/Test 3 | Other | Subjects assigned randomly to this arm will wear the study lenses sequentially as TEST 1 (etafilcon A with Lacreon), spectacles, TEST 2 (etafilcon A with Lacreon with print) and TEST 3 (etafilcon A with print) in both eyes for 8 +/-1 hours. Receives: Device: etafilcon A with Lacreon; Device: etafilcon A with Lacreon with print; Device: etafilcon A with print; Device: Spectacles (habitual) |
| Test 2/Test 3/ Spectacles/Test 1 | Other | Subjects assigned randomly to this arm will wear the study lenses sequentially as TEST 2 (etafilcon A with Lacreon with print), TEST 3 (etafilcon A with print), spectacles and TEST 1 (etafilcon A with Lacreon) in both eyes for 8 +/-1 hours. Receives: Device: etafilcon A with Lacreon; Device: etafilcon A with Lacreon with print; Device: etafilcon A with print; Device: Spectacles (habitual) |
| Test 3/Test 1/ Test 2/ Spectacles | Other | Subjects assigned randomly to this arm will wear the study lenses sequentially as TEST 3 (etafilcon A with print), TEST 1 (etafilcon A with Lacreon), TEST 2 (etafilcon A with Lacreon with print) and spectacles in both eyes for 8 +/-1 hours. Receives: Device: etafilcon A with Lacreon; Device: etafilcon A with Lacreon with print; Device: etafilcon A with print; Device: Spectacles (habitual) |
| Spectacles/Test 2/Test 1/Test 3 | Other | Subjects assigned randomly to this arm will wear the study lenses sequentially as spectacles, TEST 2 (etafilcon A with Lacreon with print), TEST 1 (etafilcon A with Lacreon) and TEST 3 (etafilcon A with print) in both eyes for 8 +/-1 hours. Receives: Device: etafilcon A with Lacreon; Device: etafilcon A with Lacreon with print; Device: etafilcon A with print; Device: Spectacles (habitual) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change From Baseline of Corneal Swelling 8 Hours Post Fit
Central corneal thickness was measured at baseline and 8-hour post fit with a modified optical pachometer on a Zeiss biomicroscope, interfaced to a PC. The pachometry measurement included seven readings; the computer is programmed to remove the high and low readings and to calculate the average of the remaining five readings. Only a single central corneal thickness measurement, the average of the 5 readings, was recorded by the investigator in the eCRF. The average percent change from baseline of corneal swelling was reported and was calculated as: ((Post fit - Baseline)/ Baseline) X 100.
Measured: 8 hours post fit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionMay 2013
- Study completionMay 2013
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 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
- NCT01765972
- Sponsor's protocol ID
- CR-5252
- Status last verified
- Jul 2016
- First submitted
- 8 Jan 2013
- 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
- Open Eye Corneal Swelling With Daily Disposable Contact Lenses and no Lens Wear
- ClinicalTrials.gov ID
- NCT01765972
- Acronym / sponsor ID
- CR-5252
- Conditions
- Corneal Swelling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 11 Jan 2013 (estimated)
- Results
- Posted 20 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this clinical trial is to evaluate the eye's response to three test soft contact lenses as well as no lens wear, with respect to Corneal Staining.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test 1/Spectacles/Test 2/Test 3 | Other | Device: etafilcon A with Lacreon, Device: etafilcon A with Lacreon with print, Device: etafilcon A with print, Device: Spectacles (habitual)Subjects assigned randomly to this arm will wear the study lenses sequentially as TEST 1 (etafilcon A with Lacreon), spectacles, TEST 2 (etafilcon A with Lacreon with print) and TEST 3 (etafilcon A with print) in both eyes for 8 +/-1 hours. |
| Test 2/Test 3/ Spectacles/Test 1 | Other | Device: etafilcon A with Lacreon, Device: etafilcon A with Lacreon with print, Device: etafilcon A with print, Device: Spectacles (habitual)Subjects assigned randomly to this arm will wear the study lenses sequentially as TEST 2 (etafilcon A with Lacreon with print), TEST 3 (etafilcon A with print), spectacles and TEST 1 (etafilcon A with Lacreon) in both eyes for 8 +/-1 hours. |
| Test 3/Test 1/ Test 2/ Spectacles | Other | Device: etafilcon A with Lacreon, Device: etafilcon A with Lacreon with print, Device: etafilcon A with print, Device: Spectacles (habitual)Subjects assigned randomly to this arm will wear the study lenses sequentially as TEST 3 (etafilcon A with print), TEST 1 (etafilcon A with Lacreon), TEST 2 (etafilcon A with Lacreon with print) and spectacles in both eyes for 8 +/-1 hours. |
| Spectacles/Test 2/Test 1/Test 3 | Other | Device: etafilcon A with Lacreon, Device: etafilcon A with Lacreon with print, Device: etafilcon A with print, Device: Spectacles (habitual)Subjects assigned randomly to this arm will wear the study lenses sequentially as spectacles, TEST 2 (etafilcon A with Lacreon with print), TEST 1 (etafilcon A with Lacreon) and TEST 3 (etafilcon A with print) in both eyes for 8 +/-1 hours. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol.
- The subject must be between 18 and 45 years of age.
- The subject must be an adapted soft contact lens wearer in both eyes.
- The subject must be of East or Southeast Asian descent, e.g. ethnic Chinese, Japanese, Korean, Malay, Vietnamese, Indonesian, Filipino, etc. (it is preferred but not required that both the subject's biological parents are East or Southeast Asian ethnicity, by self report).
Key exclusion criteria (14 listed)
- Are currently pregnant or lactating by self report (subjects who become pregnant during the study will be discontinued).
- Have any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- Have any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but may not be limited to, diabetes. hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndromes, xerophthalmia, acne rosacea, Stevens-Johnson syndromes, HIV/AIDS, hepatitis, and tuberculosis.
- Use of any topical medications such aas eye drops or ointments.
- Have entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosion, or aphakia.
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 A with LacreonAlso: Test 1contact lens with Lacreon | Device | Spectacles/Test 2/Test 1/Test 3, Test 1/Spectacles/Test 2/Test 3, Test 2/Test 3/ Spectacles/Test 1, Test 3/Test 1/ Test 2/ Spectacles |
| etafilcon A with Lacreon with printAlso: Test 2contact lens with Lacreon and cosmetic print | Device | Spectacles/Test 2/Test 1/Test 3, Test 1/Spectacles/Test 2/Test 3, Test 2/Test 3/ Spectacles/Test 1, Test 3/Test 1/ Test 2/ Spectacles |
| etafilcon A with printAlso: Test 3contact lens with print | Device | Spectacles/Test 2/Test 1/Test 3, Test 1/Spectacles/Test 2/Test 3, Test 2/Test 3/ Spectacles/Test 1, Test 3/Test 1/ Test 2/ Spectacles |
| Spectacles (habitual)Spectacles | Device | Spectacles/Test 2/Test 1/Test 3, Test 1/Spectacles/Test 2/Test 3, Test 2/Test 3/ Spectacles/Test 1, Test 3/Test 1/ Test 2/ Spectacles |
Primary outcome
Percentage Change From Baseline of Corneal Swelling 8 Hours Post Fit
Time frame: 8 hours post fit
Central corneal thickness was measured at baseline and 8-hour post fit with a modified optical pachometer on a Zeiss biomicroscope, interfaced to a PC. The pachometry measurement included seven readings; the computer is programmed to remove the high and low readings and to calculate the average of the remaining five readings. Only a single central corneal thickness measurement, the average of the 5 readings, was recorded by the investigator in the eCRF. The average percent change from baseline of corneal swelling was reported and was calculated as: ((Post fit - Baseline)/ Baseline) X 100.
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 with Lacreon, etafilcon A with Lacreon with print and etafilcon A with print in people with Corneal Swelling, run by Johnson & Johnson Vision Care, Inc. at 1 site in Canada.
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 10 inclusion and 14 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 Canada. 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 20 Jul 2016). 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?
Percentage Change From Baseline of Corneal Swelling 8 Hours Post Fit (time frame: 8 hours post fit). 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; AzTrials last refreshed its copy on 8 Nov 2026.