Clinical trial NCT03139578: Short-Term Clinical Comparison of Two Silicone Hydrogel Daily Disposable Contact Lenses
Official title: Short-Term Clinical Comparison of Two Silicone Hydrogel Daily Disposable Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2017-05-04
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Contra-lateral Assignment
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

Potential subjects must satisfy all of the following criteria to be enrolled in the study:

1. The subject must read and sign the Informed Consent form.
2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Healthy adult males or females aged 18-55 years.
4. 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.
5. The subject's refractive cylinder must be ≤1.00 D in each eye.
6. The subject must have visual acuity best correctable to 6/9 (20/30) or better for each eye.
7. 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).
8. The subject must have normal eyes (i.e., no ocular medications or infections of any type).

Exclusion Criteria:

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

1. Currently pregnant or lactating
2. 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.
3. Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear.
4. 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.
5. Extended wear contact lens correction.
6. Any current use of ocular medication.
7. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
8. 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.
9. Any contact lens-related history or signs of a corneal inflammatory event, or any other ocular abnormality that would contraindicate contact lens wear.
10. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrolment.
11. Employee, relative or friends of employees of any ophthalmic company, or investigational clinic (e.g., Investigator, Coordinator, Technician).

Primary outcomes:
measure: Overall Fit Acceptance
timeFrame: 30-45 minutes after lens settling
measure: Lens Power Requirement
timeFrame: 30-45 minutes after lens settling
Secondary outcomes:
measure: Subjective Comfort at Lens Insertion
timeFrame: Immediately upon lens insertion
measure: Subjective Comfort After Lens Settling
timeFrame: 30-45 minutes after lens settling
measure: Subjective Vision Quality
timeFrame: 30-45 minutes after lens settling
measure: Subjective Handling
timeFrame: Immediately upon lens insertion
measure: Monocular High Contrast Visual Acuity (VA)
timeFrame: 30-45 minutes after lens settling
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Aston University Optometry and Vision Science
city: Farnham
country: United Kingdom
facility: Visioncare Research
Study officials:
References: