Clinical trial NCT03228212: Evaluation of Approved and Investigational Contact Lenses
Official title: Evaluation of Approved and Investigational 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: 2017-07-24
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is a randomized, 5-visit, partial subject masked, 2x3 bilateral crossover, dispensing clinical trial. During the study, each test article will be worn in a daily wear modality for at least 6 hours per day and 5 days per week for approximately 2 weeks each. The subject will wear either the Test or Control article twice and the other study article once. The primary objective of this study is to demonstrate that the Test lens works as well, if not better compared to the Control lens with respect to CLUE (Contact Lens User Experience) comfort, Slit Lamp findings, and Distance Monocular logMAR Visual Acuity. This study will also aim to show acceptable lens fit for subjects wearing the Test lens.


Eligibility criteria: Inclusion Criteria:

* Potential subjects must satisfy all of the following inclusion 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 age ≥18 and ≤49 years of age with signed informed consent. Eligible presbyopes will be those that wear full distance contact lenses in both eyes, then wear reading glasses over them.
  4. The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 6.00 Diopter (D).
  5. The subject's refractive cylinder must be ≤ 1.00D in each eye.
  6. The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
  7. Subjects must own a wearable pair of spectacles.
  8. The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of Daily Wear per day, at least 5 days per week, for a minimum of 1 month prior to the study) and willing to wear the study lenses on a similar basis.
  9. Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 5 days per week
  10. 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 (subjects who become pregnant during the study will be discontinued).
  2. 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, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
  3. Use of any of the following medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral (e.g., Chlor-Trimeton, and Benadryl) and ophthalmic antihistamines, oral phenothiazines (e.g., Haldol, Mellaril, Thorazine, Elavil, Pamelor, Compazine), oral and ophthalmic Beta-adrenergic blockers (e.g., Propranolol, Timolol, and Practolol), systemic steroids, and any prescribed or over the counter (OTC) ocular medication.
  4. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion.
  5. Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), LASIK, etc.).
  6. Any Grade 3 or greater slit lamp findings (e.g.., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
  7. Any known hypersensitivity or allergic reaction to Optifree®PureMoist® multi-purpose care solution or Eye-Cept® rewetting drop solution
  8. Any ocular infection, allergy or clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca, ocular hypertension), or ocular conditions (e.g. strabismus), which might interfere with the study.
  9. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  10. Toric, extended wear, monovision or multi-focal contact lens correction.
  11. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
  12. Participation in clinical trials involving the Test lens within 3 months prior to study enrollment.
  13. History of binocular vision abnormality or strabismus.
  14. Employee, relative or friends of employees of any ophthalmic company, or investigational clinic (e.g., Investigator, Coordinator, Technician).

Primary outcomes:
measure: Overall Comfort
timeFrame: 2-Week Follow-up
measure: Distance Monocular LogMAR Visual Acuity
timeFrame: 2-Week Follow-up
measure: Contact Lens Fitting Acceptance Rate
timeFrame: Up to 2-Week Follow-up
measure: Number of Grade 3 or Higher Slit Lamp Findings
timeFrame: Up to 2-Week Follow-up
Secondary outcomes:
measure: Overall Quality of Vision
timeFrame: 2-Week Follow-up
measure: Overall Handling
timeFrame: 2-Week Follow-up
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Dr. James Weber & Associates, PA
state: Florida
city: Jacksonville
country: United States
facility: Vue Optical Boutique
state: Florida
city: East Lansing
country: United States
facility: VisionCare Associates
state: Michigan
city: Pickens
country: United States
facility: Pickens Family Eye Care
state: South Carolina
city: Salt Lake City
country: United States
facility: William J. Bogus, OD
state: Utah
Study officials:
References: