- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01765972
Open Eye Corneal Swelling With Daily Disposable Contact Lenses and no Lens Wear
June 18, 2018 updated by: Johnson & Johnson Vision Care, Inc.
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 Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Waterloo, Ontario, Canada
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- 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).
Exclusion Criteria:
- 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.).
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Test 1/Spectacles/Test 2/Test 3
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.
|
contact lens with Lacreon
Other Names:
contact lens with Lacreon and cosmetic print
Other Names:
contact lens with print
Other Names:
Spectacles
|
Other: Test 2/Test 3/ Spectacles/Test 1
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.
|
contact lens with Lacreon
Other Names:
contact lens with Lacreon and cosmetic print
Other Names:
contact lens with print
Other Names:
Spectacles
|
Other: Test 3/Test 1/ Test 2/ Spectacles
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.
|
contact lens with Lacreon
Other Names:
contact lens with Lacreon and cosmetic print
Other Names:
contact lens with print
Other Names:
Spectacles
|
Other: Spectacles/Test 2/Test 1/Test 3
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.
|
contact lens with Lacreon
Other Names:
contact lens with Lacreon and cosmetic print
Other Names:
contact lens with print
Other Names:
Spectacles
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8 hours post fit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
January 8, 2013
First Submitted That Met QC Criteria
January 8, 2013
First Posted (Estimate)
January 11, 2013
Study Record Updates
Last Update Posted (Actual)
June 19, 2018
Last Update Submitted That Met QC Criteria
June 18, 2018
Last Verified
July 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- CR-5252
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Corneal Swelling
-
Johnson & Johnson Vision Care, Inc.Completed
-
Medical University of GrazUnknown
-
Chang Gung Memorial HospitalCompleted
-
Hillel Yaffe Medical CenterUnknownShoulder Arthroscopy | Soft Tissue Swelling
-
University Hospital of FerraraRecruiting
-
Tarek A Abdelsalam, MDCompletedSwelling Lips & FaceEgypt
-
Ohio State UniversityCompleted
-
Cairo UniversityNot yet recruitingClinical Evaluation Including Pain and SwellingEgypt
-
University of RostockCompletedKnee Pain SwellingGermany
-
Mansoura UniversityCompleted
Clinical Trials on etafilcon A with Lacreon
-
Johnson & Johnson Vision Care, Inc.CompletedMyopiaUnited States
-
Johnson & Johnson Vision Care, Inc.Completed
-
Johnson & Johnson Vision Care, Inc.CompletedAstigmatismUnited States
-
Johnson & Johnson Vision Care, Inc.CompletedRefractive AmetropiaUnited States
-
Johnson & Johnson Vision Care, Inc.CompletedRefractive AmetropiaUnited States
-
Johnson & Johnson Vision Care, Inc.Completed
-
Johnson & Johnson Vision Care, Inc.CompletedVisual AcuityUnited Kingdom
-
Johnson & Johnson Vision Care, Inc.CompletedVisual AcuityUnited States
-
Johnson & Johnson Vision Care, Inc.Completed
-
Johnson & Johnson Vision Care, Inc.Visioncare Research Ltd.Completed