Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process 2

Not Applicable

Completed

• Conditions: Myopia

• Registration Number: NCT03701516
• Lead Sponsor: Johnson & Johnson Vision Care, Inc.

Brief Summary

This study is a multi-site, group sequential, adaptive, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear bilaterally both Test and Control lenses in a random order for 1-week each as a daily disposable modality with a wash-out period of 1 week between the wearing periods.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-24
• Study First Submitted: 2018-10-08
• Study First Submitted QC: 2018-10-08
• Study First Posted: 2018-10-10
• Primary Completion: 2019-04-01
• Study Completion: 2019-04-01
• Disposition First Submitted: 2020-03-25
• Results First Submitted: 2022-03-18
• Status Verified: 2022-04
• Results First Submitted QC: 2022-04-26
• Disposition First Submitted QC: 2022-04-26
• Last Update Submitted: 2022-04-26
• Results First Posted: 2022-04-27
• Disposition First Posted: 2022-04-27
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 268

Inclusion Criteria

• Potential subjects must satisfy all of the following criteria to be enrolled in the study:

  1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. Must be at least 18 and not more than 70 years of age (including 70) at the time of screening.
  4. The subject must be a habitual and adapted wearer of hydrogel daily disposable brand contact lens in both eyes (at least 1 month of daily wear).
  5. The subject must have normal eyes (i.e., no ocular medications or infections of any type).
  6. The subject's required spherical contact lens prescription must be in the range of -1.00 to -4.50 D in each eye.
  7. The subject's refractive cylinder must be < 0.75 D in each eye.
  8. The subject must have best corrected visual acuity of 20/25 or better in each eye.

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 that may interfere with contact lens wear.
  3. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
  4. Any ocular infection.
  5. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  6. Monovision or multi-focal contact lens correction.
  7. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
  8. History of binocular vision abnormality or strabismus.
  9. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report).
  10. Suspicion of or recent history of alcohol or substance abuse.
  11. History of serious mental illness.
  12. History of seizures.
  13. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)
  14. Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion.
  15. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale.
  16. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Overall Vision Scores	1-week Follow-up	Overall vision was assessed using the CLUE questionnaire. CLUE is a validated PRO questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using IRT follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Overall Comfort Scores	1-week Follow-up	Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.

Secondary Outcome Measures

Name	Time	Method
LLHC LogMAR Visual Performance	1-week Follow-up	Visual performance was calculated as monocular contact lens-corrected distance visual acuity using a logMAR visual acuity scale. This was evaluated under low luminance and high contrast conditions (LLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. Lower visual performance values indicate better vision. Two measurements were performed for each eye at 1-week follow-up. The average visual performance was reported for each lens type.
Average Daily Wear Time	1-week Follow-up	Average daily wear time was calculated as the number of hours between subjects reported time of insertion and time of removal of the study lenses, on an average day, at 1-week follow-up evaluation. Higher wear times indicate better lens performance. The average wear time was reported for each lens type.
HLLC LogMAR Visual Performance	1-week Follow-up	Visual performance was calculated as monocular contact lens-corrected distance visual acuity using a logMAR visual acuity scale. This was evaluated under high luminance and low contrast conditions (HLLC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. Lower visual performance values indicate better vision. Two measurements were performed for each eye at 1-week follow-up. The average visual performance was reported for each lens type.

Trial Locations

Locations (12)

EyeCenter Optometrics; 🇺🇸 Rocklin, California, United States

Fleming Island Vision Center; 🇺🇸 Fleming Island, Florida, United States

Bartram Eye Clinic; 🇺🇸 Jacksonville, Florida, United States

Sabal Eye Care; 🇺🇸 Longwood, Florida, United States

Maitland Vision Center; 🇺🇸 Maitland, Florida, United States

St. Johns Eye Associates; 🇺🇸 Saint Augustine, Florida, United States

Sacco Eye Group; 🇺🇸 Vestal, New York, United States

ProCare Vision Centers; 🇺🇸 Granville, Ohio, United States

Eyecare Professionals of Powell; 🇺🇸 Powell, Ohio, United States

Primary Eyecare Group; 🇺🇸 Brentwood, Tennessee, United States

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