Clinical trial NCT02625220: Dispensing Evaluation of Investigational Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia; Astigmatism
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2015-12-09
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Non-randomized, single-masked, 2-visit, bilateral wear, single-arm dispensing study to evaluate the visual acuity, rotational performance, lens fit, stability and subjective characteristics of a senofilcon-based JJVCI investigational toric contact lens design.


Eligibility criteria: Inclusion Criteria:

* Healthy adult males or females that are ≥18 years of age and ≤39 years of age.
* 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 this clinical protocol.
* The subject must be a habitual toric contact lens wearer. Habitual wearer is defined as someone who wears toric lenses for at least 6 hours a day, 5 days a week for the past 30 days.
* Subject's vertex corrected spherical component of their distance refraction must be between -1.50 Diopters Sphere (DS) to -4.00 DS (inclusive) in each eye.
* Subject's vertex corrected refractive cylinder must be between -0.75 and -1.50 Diopters Cylinder (DC) (inclusive) in each eye.
* Subject's refractive cylinder axis must be within 180±15° and 90±15° in each eye.
* If needed, the subject must have a wearable pair of spectacles with 20/30 or better vision Ocular Uterque (OU). If spectacles are not needed, the subject must have 20/40 or better vision OU without correction.
* Subject's best corrected distance acuity must be 20/25-2 or better in each eye.

Exclusion Criteria:

* Females who are currently pregnant or lactating.
* Any ocular or systemic allergies or diseases that may contraindicate contact lens wear.
* Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndromes, xerophthalmia, acne rosacea, and/or Stevens-Johnson syndromes, by self-report.
* Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV), by self-report.
* Habitual wearer of extended wear contact lenses.
* Any previous history of ocular and/or refractive surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
* History of seizures.
* Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by report.
* History of binocular vision abnormality or strabismus, by self-report.
* Habitual wearer of rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
* Employee and family members of employee of investigational clinic (e.g., Investigator, Coordinator, Technician).
* Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
* Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, and conjunctival injection) on the FDA classification scale.
* Any history of a contact lens-related corneal inflammatory event within the past year that may contraindicate contact lens wear.
* Any active ocular infection.
* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
* Any fluctuations in vision due to clinically significant dry eye or other ocular conditions.

Primary outcomes:
measure: Proportion of Eyes With Monocular Visual Acuity Better Than 20/40
timeFrame: 7 day follow-up
measure: The Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees
timeFrame: 15 Minutes Post Insertion
measure: Proportion of Subjects Eyes With Lens Stability With Blink Within 5 Degrees
timeFrame: 15 Minutes Post Insertion
measure: Proportion of Subject Eyes With Acceptable Lens Fit
timeFrame: 15 Minute Post Insertion
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Edward S. Wygonik, OD
state: Florida
city: Pembroke Pines
country: United States
facility: The Eye Center
state: Florida
city: Winter Park
country: United States
facility: Eye Associates of Winter Park
state: Florida
city: Bloomington
country: United States
facility: Eyecare Associates
state: Illinois
city: Bloomington
country: United States
facility: Indiana University College of Optometry
state: Indiana
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: Albuquerque
country: United States
facility: ABQ Eyecare
state: New Mexico
city: Vestal
country: United States
facility: Sacco Eye Group
state: New York
city: Springfield
country: United States
facility: New Image Eye Center
state: Ohio
city: Westerville
country: United States
facility: Professional Vision Care
state: Ohio
city: Warwick
country: United States
facility: West Bay Eye Associates
state: Rhode Island
city: Memphis
country: United States
facility: Total Eye Care PA
state: Tennessee
Study officials:
References: