An Investigation of the Impact of Localized Topical Anesthesia of the Ocular Surface on End-of-day Contact Lens Discomfort

Johnson & Johnson (J&J)

Status: Completed

Conditions: Visual Acuity

Treatments: Diagnostic Test: Local Anesthesia; Diagnostic Test: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03733899

CR-6292

Details and patient eligibility

About

This is a controlled, randomized, subject-masked, 3x3 crossover, non-dispensing, contralateral study. Twenty subjects will be recruited based on their scores (with their habitual lenses) from the Contact Lens Dry Eye Questionnaire-8 and examined on four occasions.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

  1. They are of legal age (18 years) and capacity of volunteer.

  2. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.

  3. They must appear able and willing to adhere to the instructions set forth in this clinical protocol.

  4. They have worn the same brand of soft spherical contact lenses for at least the previous three months, by self-report.

  5. They are defined as 'symptomatic' contact lens wearers (CLDEQ-8 score of 20-37) with their habitual contact lenses.

  6. They are willing to wear their lenses for approximately 14 hours on study days.

  7. They have a wearable pair of spectacles, if applicable.

  8. They agree not to participate in other clinical research for the duration of this study.

  9. They can attain high contrast logMAR visual acuity of 0.20 or better in their habitual contact lenses in each eye.

     Exclusion Criteria:

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

  1. They have an ocular disorder, which would normally contra-indicate contact lens wear.
  2. They have a systemic disorder, which would normally contra-indicate contact lens wear.
  3. They are using any topical medication such as eye drops or ointment.
  4. They have had cataract or corneal refractive surgery.
  5. They are pregnant or breast-feeding by self-report.
  6. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV), by self-report.
  7. They have any known hypersensitivity or allergic reaction to any of the known ingredients in the anesthetic.
  8. They have a history of severe allergic reaction or anaphylaxis.
  9. They have a history of cardiac disease or hyperthyroidism.
  10. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
  11. They are an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
  12. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
  13. They have grade 3 or greater of any of the following ocular surface signs which would contraindicate contact lens wear: corneal edema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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22 participants in 6 patient groups

Upper lid margin/Lower lid margin/Cornea

Experimental group

Description:

Subjects that are at least 18 years of age wearing their habitual lenses will be randomized into one of six unique sequences of an ocular surface region. For each region within a sequence, the two treatments will be randomly assigned to the left and right eye (anesthesia left eye/placebo right eye OR placebo left eye/anesthesia left eye).

Treatment:

Diagnostic Test: Placebo

Diagnostic Test: Local Anesthesia

Lower lid margin/Cornea/ Upper lid margin

Experimental group

Description:

Subjects that are at least 18 years of age wearing their habitual lenses will be randomized into one of six unique sequences. For each region within a sequence, the two treatments will be randomly assigned to the left and right eye (anesthesia left eye/placebo right eye OR placebo left eye/anesthesia left eye).

Treatment:

Diagnostic Test: Placebo

Diagnostic Test: Local Anesthesia

Cornea/Upper lid margin/Lower lid margin

Experimental group

Description:

Subjects that are at least 18 years of age wearing their habitual lenses will be randomized into one of six unique sequences. For each region within a sequence, the two treatments will be randomly assigned to the left and right eye (anesthesia left eye/placebo right eye OR placebo left eye/anesthesia left eye).

Treatment:

Diagnostic Test: Placebo

Diagnostic Test: Local Anesthesia

Cornea/Lower lid margin/Upper lid margin

Experimental group

Description:

Subjects that are at least 18 years of age wearing their habitual lenses will be randomized into one of six unique sequences. For each region within a sequence, the two treatments will be randomly assigned to the left and right eye (anesthesia left eye/placebo right eye OR placebo left eye/anesthesia left eye).

Treatment:

Diagnostic Test: Placebo

Diagnostic Test: Local Anesthesia

Upper lid margin/Cornea/Lower lid margin

Experimental group

Description:

Subjects that are at least 18 years of age wearing their habitual lenses will be randomized into one of six unique sequences. For each region within a sequence, the two treatments will be randomly assigned to the left and right eye (anesthesia left eye/placebo right eye OR placebo left eye/anesthesia left eye).

Treatment:

Diagnostic Test: Placebo

Diagnostic Test: Local Anesthesia

Lower lid margin/Upper lid margin/Cornea

Experimental group

Description:

Subjects that are at least 18 years of age wearing their habitual lenses will be randomized into one of six unique sequences. For each region within a sequence, the two treatments will be randomly assigned to the left and right eye (anesthesia left eye/placebo right eye OR placebo left eye/anesthesia left eye).

Treatment:

Diagnostic Test: Placebo

Diagnostic Test: Local Anesthesia