Clinical Evaluation of Approved and Investigational Contact Lenses Using New UV Additive

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.

Study Overview

• Status: Completed
• Conditions: Visual Acuity
• Intervention / Treatment: Device: senofilcon A with new UV blocker; Device: senofilcon A

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32205
    • Longwood, Florida, United States, 32779
    • Sarasota, Florida, United States, 34242
  • New Jersey
    • Closter, New Jersey, United States, 07624
  • New York
    • Vestal, New York, United States, 13850
  • South Carolina
    • Pickens, South Carolina, United States, 29671

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational Contact Lens with UV Blocker; Subjects will be dispensed the investigational contact lens with UV blocker to wear daily for a period of 12 weeks with follow-up visits occurring after 1, 2, 4, 8, and 12 weeks. Afterwards, the subjects will wear their habitual contact lenses for a period of two weeks with weekly visits.	Device: senofilcon A with new UV blocker; Investigational Contact Lens
Active Comparator: Marketed Contact Lens; Subjects will be dispensed the marketed contact lens to wear daily for a period of 12 weeks with follow-up visits occurring after 1, 2, 4, 8, and 12 weeks. Afterwards, the subjects will wear their habitual contact lenses for a period of two weeks with weekly visits.	Device: senofilcon A; J&J Marketed Contact Lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eyestrain Related to Glare	Eyestrain related to glare was assessed at the 2-, 4-, 8- and 12- week follow-up visits using an 11-item questionnaire. This questionnaire assesses patient-experience attributes of soft contact lenses. Derived eyestrain related to glare scores using Item Response Theory (IRT) follow a normal distribution with a mean of 50 and a standard deviation of 10. Scores in this study ranged from 30 to 70. Lower scores indicate better performance. This questionnaire is still under development and the data collected is considered exploratory.	Up to 12-Week Follow-up
Distance Monocular logMAR Visual Acuity (VA)	Distance logMAR Visual Acuity was assessed for each subject and eye at 2-, 4- 8- and 12-weeks. The average logMAR visual acuity for each lens and time point was reported. Lower values of logMAR indicate better vision.	Up to 12-Week Follow-up
Percentage of Eyes With Grade 3 or Higher Slit Lamp Findings	Slit lamp findings were graded using a FDA Grade Scale, 0 = None, 1 = Slight, 2 = Moderate, 3 = Significant, 4 = Advanced. Measurements were taken in each subject eye at the initial visit, 2-4-8- and 12-week follow-ups. A new response variable was derived by dichotomizing the data as follows: 1 if a Grade 3or higher SLF was observed and 0 otherwise. The Percentage of eyes with Grade 3 or higher SLFs was reported for each lens and time point.	Up to 12-Week Follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contact Lens Wearing Time	Contact lens wearing time (hours) was self-reported by each subject at the 2-, 4-, 8- and 12-week follow-ups. The average contact lens wearing time (hours) for each lens and time point was reported.	Up to 12-Week Follow-up
Percentage of Eyes With Subject Reported Symptoms Problems or Complaints	Symptoms, problems and complaints are subject reported and were collected for each subject eye at the 1-, 2-, 4-, 8- and 12-week follow-up evaluations. The data is reported as a binary outcome of yes if a subject experience a problem or complaint or no otherwise. Symptoms, problems and complaints include the following: Burning/Stinging, Itchiness/Scratchiness, Dryness, Lens Awareness, Grittiness/Foreign Body Sensation, Redness, Irritation/Discomfort, Cloudy/Blurry/Hazy, Variable Vision and Other The Percentage of subjects eyes with symptoms, problems or complaints was reported for each lens and time point.	Up to 12-Week Follow-up

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): February 18, 2017
• Study Completion (Actual): February 18, 2017

Study Registration Dates

• First Submitted: October 31, 2016
• First Submitted That Met QC Criteria: November 30, 2016
• First Posted (Estimate): December 5, 2016

Study Record Updates

• Last Update Posted (Actual): July 19, 2018
• Last Update Submitted That Met QC Criteria: July 18, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: CR-5638

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes