Short-Term Clinical Comparison of Two Silicone Hydrogel Daily Disposable Contact Lenses
1 other identifier
interventional
51
1 country
2
Brief Summary
This will be a 2 period one-day, double-masked, randomized, repeated measures, non-dispensing, cross-over study where the main purpose of this study is to compare the performance of a new daily disposable silicone hydrogel lens with that of an existing similar lens.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2017
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 28, 2017
CompletedFirst Submitted
Initial submission to the registry
May 2, 2017
CompletedFirst Posted
Study publicly available on registry
May 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 22, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 22, 2017
CompletedResults Posted
Study results publicly available
December 11, 2018
CompletedFebruary 1, 2019
January 1, 2019
6 months
May 2, 2017
October 18, 2018
January 11, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Overall Fit Acceptance
Overall lens fit acceptance was assessed by the investigator based on lens fitting characteristics and graded on a scale of 0 to 5, where 0=should not be worn and 5=perfect fit. The score ranges from 0 to 5, where higher scores indicate better fitting. The number of eye for each Grade was reported.
30-45 minutes after lens settling
Lens Power Requirement
The lens power requirements (aka sphere requirements) for each lens type was calculated by summing the lens power and the spherical over-refraction. Then the difference of lens power requirement between the Test and Control lenses was calculated (Test-Control).
30-45 minutes after lens settling
Secondary Outcomes (5)
Subjective Comfort at Lens Insertion
Immediately upon lens insertion
Subjective Comfort After Lens Settling
30-45 minutes after lens settling
Subjective Vision Quality
30-45 minutes after lens settling
Subjective Handling
Immediately upon lens insertion
Monocular High Contrast Visual Acuity (VA)
30-45 minutes after lens settling
Study Arms (4)
C 8.5\C 9.0\T 8.5\T 9.0
EXPERIMENTALSubjects randomized to this sequence received Control lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the first period and then received Test lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the second period.
C 9.0\C 8.5\T 9.0\T 8.5
EXPERIMENTALSubjects randomized to this sequence received Control lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the first period and then received Test lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the second period.
T 8.5\T 9.0\C 8.5\C 9.0
EXPERIMENTALSubjects randomized to this sequence received Test lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the first period and then received Control lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the second period.
T 9.0\T 8.5\C 9.0\C 8.5
EXPERIMENTALSubjects randomized to this sequence received Test lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the first period and then received Control lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the second period.
Interventions
senofilcon A contact lenses with 8.5 base curve
senofilcon A contact lenses with 9.0 base curve
narafilcon A contact lenses with 8.5 base curve
narafilcon A contact lenses with 9.0 base curve
Eligibility Criteria
You may qualify if:
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- The subject must read and sign the Informed Consent form.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Healthy adult males or females aged 18-55 years.
- The subject's spherical contact lens requirement in the range +2.00 D to +4.00 D or -1.00 D to -6.00 D.
- The subject's refractive cylinder must be ≤1.00 D in each eye.
- The subject must have visual acuity best correctable to 6/9 (20/30) or better for each eye.
- The subject is a current soft contact lens wearer (defined as a minimum of 6 hours of DW per day, at least 5 days per week, for a minimum of 1 month prior to the study).
- The subject must have normal eyes (i.e., no ocular medications or infections of any type).
You may not qualify if:
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Currently pregnant or lactating
- Any systemic disease (e.g., Sjögren's Syndrome),allergies, infectious disease (e.g., hepatitis,tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study.
- Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear.
- Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion.
- Extended wear contact lens correction.
- Any current use of ocular medication.
- Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
- Any greater than Grade 2 slit lamp findings (e.g., oedema, corneal neovascularisation, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale or any other ocular abnormality that may contraindicate contact lens wear.
- Any contact lens-related history or signs of a corneal inflammatory event, or any other ocular abnormality that would contraindicate contact lens wear.
- Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrolment.
- Employee, relative or friends of employees of any ophthalmic company, or investigational clinic (e.g., Investigator, Coordinator, Technician).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Aston University Optometry and Vision Science
Birmingham, United Kingdom
Visioncare Research
Farnham, United Kingdom
Results Point of Contact
- Title
- Anna Sulley BSc MCOptom FAAO
- Organization
- Johnson & Johnson Vision
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Both the investigator and the subjects are masked to the identity of the study lenses. Lenses were over-labelled and coded to mask the lens foil. Over-labelling was carried out by the study sponsor following specific SOPs (see ICH GCP guidelines Section 5.13).
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2017
First Posted
May 4, 2017
Study Start
April 28, 2017
Primary Completion
October 22, 2017
Study Completion
October 22, 2017
Last Updated
February 1, 2019
Results First Posted
December 11, 2018
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share