Clinical trial NCT03733899: An Investigation of the Impact of Localized Topical Anesthesia of the Ocular Surface on End-of-day Contact Lens Discomfort
Official title: An Investigation of the Impact of Localized Topical Anesthesia of the Ocular Surface on End-of-day Contact Lens Discomfort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-07
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Subjective Comfort Scores
timeFrame: 5 and 10 Minutes post-treament
measure: Change in Subjective Comfort Scores From Pre-treatment to Post-treatment
timeFrame: 14-Hours upon Lens-Insertion (pre-treatment), and 10 Minutes post-treament
measure: Subjective Comfort Score Difference Between Post-treatment and Post-insertion Within Anesthetic
timeFrame: Immediately after lens-insertion, 5 and 10 minutes post-treatment
Secondary outcomes:
measure: Change in Subjective Comfort Between Ocular Regions at Posttreatment Within Anesthetic
timeFrame: 5 and 10 minutes post treatment
measure: Change in Subjective Comfort From Pre-treatment to Post-Treatment Between Ocular Regions
timeFrame: 14 hours upon lens-insertion (pre-treatment), 5- and 10- minutes post-treatment
measure: Subjective Comfort Difference Between Post-removal and Preinsertion Within Anesthetic and Cornea
timeFrame: Immediately before lens-insertion (pre-insertion), 30 seconds after lens removal
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The University of Manchester
Study officials:
References: