Clinical trial NCT03086447: Evaluation of Astigmatic Contact Lenses
Official title: Evaluation of Astigmatic 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: 2017-03-22
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized, double-masked, 5-visit, bilateral dispensing, parallel group study to demonstrate that the investigational contact lens meets the design requirements related to corneal staining, lens fit, visual acuity and rotational performance as well as subjective comfort and handling. Subjects will wear the contact lenses for a total of 28-36 days.


Eligibility criteria: Inclusion Criteria:

* 1) Healthy adult males or females age ≥18-40 years of age with signed informed consent.

  2) The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

  3) Subject must be a habitual soft toric contact lens wearer. Habitual wearer is defined as someone who wears contact lenses for at least 6 hours a day, 5 days a week for the past 30 days.

  4) Subject's vertex corrected spherical component of their distance refraction must be between -1.00 to -4.75 Diopter (D) (inclusive) in each eye.

  5) Subject's vertex corrected refractive cylinder must be between -0.75 and -1.50 DC (inclusive) in each eye.

  6) Subject's refractive cylinder axis must be 180±25 and 90±15 in each eye. 7) The subject must have visual acuity best correctable to 20/25 or better for each eye 8) The subject must read and sign the Informed Consent form.

Exclusion Criteria:

* 1) Women who are pregnant or breastfeeding, 2) Any ocular or systemic allergies or diseases that may contraindicate contact lens wear.

  3) Any ocular medications use within the last one month. 4) Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.

  5) Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV), by self-report.

  6) Habitual wearer of extended wear contact lenses. 7) Known sensitivity to Revitalens OcuTec® 8) Any previous history of ocular and/or refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.).

  9) A clinical finding or history of entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion, by self-report.

  10) History of binocular vision abnormality or strabismus, by self-report. 11) Habitual wearer of rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.

  12) Employee of investigational clinic (e.g., Investigator, Coordinator, Technician).

  13) Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.

  14) Clinically significant (grade 3 or higher) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities, bulbar injection or any other abnormalities which would contraindicate contact lens wear.

  15) Any history of a contact lens-related corneal inflammatory event within the past year that may contraindicate contact lens wear.

  16) Any active ocular infection. 17) Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

  18) Any fluctuations in vision due to clinically significant dry eye or other ocular conditions.

Primary outcomes:
measure: Monocular Distance Visual Acuity (VA)
timeFrame: Up to 4-Week Follow-up
measure: Lens Fit Acceptance
timeFrame: 15 Minutes Post Lens Fitting
measure: Lens Stability With Blink
timeFrame: 15 Minutes Post Lens Fitting
measure: Absolute Lens Rotation
timeFrame: 15-minutes Post Lens Insertion
measure: Corneal Staining
timeFrame: Up to 4-Week Follow-up
Secondary outcomes:
measure: Overall Comfort
timeFrame: Up to 4- Week Follow-up
measure: Overall Handling
timeFrame: Up to 4- Week Follow-up
measure: Monocular Distance Visual Acuity (VA)
timeFrame: 15 Minutes Post Lens Fitting
Other outcomes:
Locations:
city: Whittier
country: United States
facility: Golden Optometric Group
state: California
city: Jacksonville Beach
country: United States
facility: Edward S. Wygonik, OD
state: Florida
city: Jacksonville
country: United States
facility: Dr. James Weber & Associates, PA
state: Florida
city: Longwood
country: United States
facility: Sabal Eye Care
state: Florida
city: Maitland
country: United States
facility: Maitland Vision Center
state: Florida
city: Bloomington
country: United States
facility: Indiana University School of Optometry
state: Indiana
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: Albuquerque
country: United States
facility: ABQ Eye Care
state: New Mexico
city: Vestal
country: United States
facility: Sacco Eye Group
state: New York
city: Granville
country: United States
facility: ProCare Vision Centers
state: Ohio
city: Powell
country: United States
facility: EyeCare Professionals of Powell
state: Ohio
city: Westerville
country: United States
facility: Professional Vision Care, Inc
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
city: Amarillo
country: United States
facility: Premier Vision
state: Texas
city: Salt Lake City
country: United States
facility: William J Bogus, OD, FAAO
state: Utah
city: Salem
country: United States
facility: Botetourt Eyecare, LLC
state: Virginia
Study officials:
References: