Dispensing Evaluation of Investigational Contact Lenses

NCT02625220 | Completed Results DMC

• 1 other identifier: CR-5769
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 12

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.

Conditions

Myopia; Astigmatism

Outcome Measures

Primary Outcomes (4)

• Proportion of Eyes With Monocular Visual Acuity Better Than 20/40

  Monocular visual acuity was assessed using distance Snellen visual acuity. Visual Acuity data was dichotomized such that 'response=1' if a subjects has 20/40 or better and 'response=0' if subject has worse than 20/40. The proportion of eyes with 20/40 or better was reported.

  7 day follow-up

• The Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees

  Absolute rotation was measured using a slit lamp. Absolute rotation measured at 15-minute post insertion was categorized into a binary outcome as 'response=1' if the absolute rotation is less than or equal to 10 degrees or 'response=0' otherwise. The proportion of eyes with absolute rotation less than or equal to 10 degrees was reported.

  15 Minutes Post Insertion

• Proportion of Subjects Eyes With Lens Stability With Blink Within 5 Degrees

  Lens stability with blink was measured using a slit lamp. The rotational stability of the lens during a series of normal (unforced) blinks was measured for both eyes. The data was dichotomized as 'response=1' if the lens stability was less than or equal to 5 degrees or 'response=0' otherwise. The proportion of eyes with rotational stability of 5 degrees or lower was reported.

  15 Minutes Post Insertion

• Proportion of Subject Eyes With Acceptable Lens Fit

  Acceptability of contact lens fit was assessed via slit lamp and was reported as a binary response as Acceptable or Unacceptable. The proportion of eyes with acceptable fit was reported.

  15 Minute Post Insertion

Study Arms (1)

Prototype toric lens senofilcon A

EXPERIMENTAL

Subjects will wear the senofilcon A prototype toric contact lens bilaterally for 6-8 days as a daily disposable modality.

Device: Prototype toric lens senofilcon A

Interventions

Prototype toric lens senofilcon A DEVICE

Investigational prototype

Prototype toric lens senofilcon A

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (12)

Edward S. Wygonik, OD

Jacksonville, Florida, 32250, United States

Location

The Eye Center

Pembroke Pines, Florida, 33024, United States

Location

Eye Associates of Winter Park

Winter Park, Florida, 32792, United States

Location

Eyecare Associates

Bloomington, Illinois, 61701, United States

Location

Indiana University College of Optometry

Bloomington, Indiana, 47405, United States

Location

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

Location

ABQ Eyecare

Albuquerque, New Mexico, 87109, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

New Image Eye Center

Springfield, Ohio, 45503, United States

Location

Professional Vision Care

Westerville, Ohio, 43081, United States

Location

West Bay Eye Associates

Warwick, Rhode Island, 02888, United States

Location

Total Eye Care PA

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Conditions

Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Benjamin Straker, BAppSc(Optom)(HonS) Principal Research Optometrist
• Organization: Johnson & Johnson Vision Care Inc.

Bstraker@ITS.JNJ.com

904-443-3500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: December 9, 2015
• Study Start: October 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: June 7, 2017
• Results First Posted: June 7, 2017

Record last verified: 2017-05

Locations

US (12)