Clinical trial NCT02982018: Clinical Evaluation of Approved and Investigational Contact Lenses Using New UV Additive
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2016-12-05
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized, 8-visit dispensing study over 14 weeks to evaluate the safety and efficacy of an investigational contact lens with a new UV blocker compared to a marketed contact lens.


Eligibility criteria: Inclusion Criteria:

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 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 Diopters (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 20/25+3 or better for each eye.
7. Subjects should 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:

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. Seldane, 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 by keratometry.
5. Any previous, or planned, ocular or interocular surgery (e.g.., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.).
6. Any grade 2 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. History of binocular vision abnormality or strabismus.
13. Employee or relative of employees of sponsor or investigational clinic (e.g., Investigator, Coordinator, Technician).

Primary outcomes:
measure: Eyestrain Related to Glare
timeFrame: Up to 12-Week Follow-up
measure: Distance Monocular logMAR Visual Acuity (VA)
timeFrame: Up to 12-Week Follow-up
measure: Percentage of Eyes With Grade 3 or Higher Slit Lamp Findings
timeFrame: Up to 12-Week Follow-up
Secondary outcomes:
measure: Contact Lens Wearing Time
timeFrame: Up to 12-Week Follow-up
measure: Percentage of Eyes With Subject Reported Symptoms Problems or Complaints
timeFrame: Up to 12-Week Follow-up
Other outcomes:
Locations:
city: Jacksonville
country: United States
state: Florida
city: Longwood
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Closter
country: United States
state: New Jersey
city: Vestal
country: United States
state: New York
city: Pickens
country: United States
state: South Carolina
Study officials:
References: