Clinical trial NCT03913377: Ocular Characteristics in Contact Lens and Spectacle Wear
Official title: Ocular Characteristics in Contact Lens and Spectacle Wear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-12
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This clinical study will investigate the difference in ocular characteristics between contact lens wear and spectacle wear among habitual contact lens wearers, using a 2-treatment by 2-period cross-over design. There will be a 1-week washout between the two study periods to eliminate any potential carryover effect.


Eligibility criteria: Inclusion Criteria:

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

  1. The subject will have completed the pre-screening Classification questionnaire.
  2. Subject must have a working cell phone capable of sending and receiving text messages.
  3. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  4. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
  5. Between 18 and 42 (inclusive) years of age at the time of screening
  6. Be a current soft contact lens wearer in both eyes with a minimum of 5 days/week wear time over the last 1 month by self-report OR be a full-time spectacle wearer (7 days/ week) without contact lens wear over the last 6 months.
  7. Subjects must be willing to adhere to spectacle-only refractive correction for approximately 1 week.
  8. Subjects must possess a functional / usable pair of spectacles with which they can achieve 20/20 Snellen visual acuity or better at distance and near, and bring them to the visit
  9. The subject's vertex corrected spherical distance refraction must be in the range (+/-0.25 D) of -2.00 D to -6.00 D (inclusive) in each eye.
  10. The subject's vertex corrected refractive cylinder must be equal or less than -0.75 diopters in each eye.
  11. Contact lens wearers must have spherical best corrected visual acuity of 20/25 or better in each eye.
  12. Snellen visual acuity at distance and near must be within 1 line between subject's own spectacle and the manifest refraction, distance and near, OD \& OS.

      Exclusion Criteria:
* Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. Currently pregnant or lactating, by self-report
  2. Any ocular or systemic allergies, disease or use of medication which may interfere with contact lens wear and/or participation in the study (at the discretion of the investigator).
  3. Any active ocular abnormalities/conditions that may interfere with contact lens wear and/or participation in the study (at the discretion of the investigator).
  4. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear
  5. Habitual contact lens wear modality as extended wear (≥1 night per month of extended wear).
  6. Habitual contact lens is rigid gas permeable, toric, monovision or multi-focal
  7. Habitual spectacle contains an add power, photochromic or tint.
  8. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
  9. Participation in any contact lens or lens care product clinical trial within 2 weeks prior to study enrollment.
  10. Employee or employee's immediate family member of clinical site (e.g., Investigator, Coordinator, Technician)
  11. Current habitual use of Restasis, Xiidra, ocular steroids, or any medication (RX or OTC) that may interfere with contact lens wear and/or participation in the study (at the discretion of the investigator)
  12. 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.
  13. Any Grade 3 or greater biomicroscopy findings (this includes, corneal edema, corneal staining, corneal vascularization, conjunctival injection, tarsal abnormalities, bulbar injection) on the FDA classification scale (CTP-2018).
  14. Accommodative/binocular dysfunction, determined by study procedures.

Primary outcomes:
measure: Non-Invasive Break Up Time (NIBUT) or Non-Invasive Keratograph Break Up Time (NIKBUT)
timeFrame: 1-Week Follow-up
Secondary outcomes:
measure: Total Scores of Meibomian Gland Expressibility (MGE)
timeFrame: 1-Week Follow-up
measure: Conjunctival Staining
timeFrame: 1-Week Follow-up
measure: Number of Eyes With Clinically Significant (Grade 3 or 4 of Overall Classification) Lid Wiper Epitheliopathy
timeFrame: 1-Week Follow-up
measure: Meibomian Gland Expressibility (MGE) Grades
timeFrame: 1-Week Follow-up
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: VRC-East
state: Florida
city: Longwood
country: United States
facility: Sabal Eye Care
state: Florida
city: New York
country: United States
facility: Manhattan Vision Associates
state: New York
Study officials:
References: