- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02394808
2-week Evaluation of Marketed Silicone Hydrogel Contact Lenses in Indian Population
June 18, 2018 updated by: Johnson & Johnson Vision Care, Inc.
2-week Dispensing Cross-Over Evaluation of Marketed Silicone Hydrogel Contact Lenses in an Indian Population
The primary objective of this study is to evaluate the clinical performance of two marketed silicone hydrogel contact lenses in an Indian population in the following areas: physiological characteristics, comfort characteristics and vision characteristics.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
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
-
-
Tamil Nadu
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Chennai, Tamil Nadu, India, 600006
-
-
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 39 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The subject must read, understand English, 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 this clinical protocol.
- The subject must be 18 and less than 40 years of age.
- The subject's corrected spherical equivalent distance refraction must be in the range of -1.00 to -5.00D in each eye with visual acuity of 20/25 provided study lenses in each eye.
- The subject must have less than -1.00 D of cylindrical refraction.
- The subject must have best corrected visual acuity of 20/25 or better in each eye.
- The subject must be an adapted soft contact lens wearer in both eyes.
- The subject must have normal eyes.
Exclusion Criteria:
- Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued)
- Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
- Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
- Any previous, or planned ocular or interocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.).
- Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g. past peripheral ulcer, or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
- Any ocular infections
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment
- History of binocular vision abnormality or strabismus.
- Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV) by self report.
- 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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test Lens 1
senofilcon A (Approved contact lens material)
|
One fresh pair of contact lenses worn for 11 (+/-2) days, for a minimum of 6 hours per day
One fresh pair of contact lenses worn for 11 (+/-2) days, for a minimum of 6 hours per day
|
Active Comparator: Test Lens 2
lotrafilcon B (Approved contact lens material)
|
One fresh pair of contact lenses worn for 11 (+/-2) days, for a minimum of 6 hours per day
One fresh pair of contact lenses worn for 11 (+/-2) days, for a minimum of 6 hours per day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective Overall Comfort
Time Frame: 11 days Post fit
|
Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE).
CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65.
Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
|
11 days Post fit
|
Subjective Overall Quality of Vision
Time Frame: 11 days post fit
|
Subjective Overall quality of Vision was evaluated using the Contact Lens User Experience Comfort scores (CLUE).
CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65.
Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
|
11 days 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 (Actual)
January 1, 2015
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
March 16, 2015
First Submitted That Met QC Criteria
March 16, 2015
First Posted (Estimate)
March 20, 2015
Study Record Updates
Last Update Posted (Actual)
June 19, 2018
Last Update Submitted That Met QC Criteria
June 18, 2018
Last Verified
March 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- CR-5625
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.
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