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

• ClinicalTrials.gov Identifier: NCT03733899
• Recruitment Status: Completed
• First Posted: November 7, 2018
• Results First Posted: February 6, 2020
• Last Update Posted: March 11, 2020
• Sponsor: Johnson & Johnson Vision Care, Inc.
• Information provided by (Responsible Party): Johnson & Johnson Vision Care, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Visual Acuity	Diagnostic Test: Local Anesthesia; Diagnostic Test: Placebo	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: An Investigation of the Impact of Localized Topical Anesthesia of the Ocular Surface on End-of-day Contact Lens Discomfort
• Actual Study Start Date: November 7, 2018
• Actual Primary Completion Date: February 7, 2019
• Actual Study Completion Date: February 7, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Upper lid margin/Lower lid margin/Cornea; 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).	Diagnostic Test: Local Anesthesia; Minims Proxymetacaine hydrochloride Eye Drops; Diagnostic Test: Placebo; Sodium Chloride Solution
Experimental: Lower lid margin/Cornea/ Upper lid margin; 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).	Diagnostic Test: Local Anesthesia; Minims Proxymetacaine hydrochloride Eye Drops; Diagnostic Test: Placebo; Sodium Chloride Solution
Experimental: Cornea/Upper lid margin/Lower lid margin; 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).	Diagnostic Test: Local Anesthesia; Minims Proxymetacaine hydrochloride Eye Drops; Diagnostic Test: Placebo; Sodium Chloride Solution
Experimental: Cornea/Lower lid margin/Upper lid margin; 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).	Diagnostic Test: Local Anesthesia; Minims Proxymetacaine hydrochloride Eye Drops; Diagnostic Test: Placebo; Sodium Chloride Solution
Experimental: Upper lid margin/Cornea/Lower lid margin; 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).	Diagnostic Test: Local Anesthesia; Minims Proxymetacaine hydrochloride Eye Drops; Diagnostic Test: Placebo; Sodium Chloride Solution
Experimental: Lower lid margin/Upper lid margin/Cornea; 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).	Diagnostic Test: Local Anesthesia; Minims Proxymetacaine hydrochloride Eye Drops; Diagnostic Test: Placebo; Sodium Chloride Solution

Outcome Measures

Primary Outcome Measures :

1. Subjective Comfort Scores [ Time Frame: 5 and 10 Minutes post-treament ]
   Subjects were asked to rate how comfortable each eye was overall using a visual analog scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable.
2. Change in Subjective Comfort Scores From Pre-treatment to Post-treatment [ Time Frame: 14-Hours upon Lens-Insertion (pre-treatment), and 10 Minutes post-treament ]
   Subjects were asked to rate how comfortable each eye was overall using a visual analog scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable. Subjects wore their habitual contacts during the pre-treatment assessment.
3. Subjective Comfort Score Difference Between Post-treatment and Post-insertion Within Anesthetic [ Time Frame: Immediately after lens-insertion, 5 and 10 minutes post-treatment ]
   Subjects were asked to rate how comfortable each eye was overall on the scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable.

Secondary Outcome Measures :

1. Change in Subjective Comfort Between Ocular Regions at Posttreatment Within Anesthetic [ Time Frame: 5 and 10 minutes post treatment ]
   Subjects were asked to rate how comfortable each eye was overall on the scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable.
2. Change in Subjective Comfort From Pre-treatment to Post-Treatment Between Ocular Regions [ Time Frame: 14 hours upon lens-insertion (pre-treatment), 5- and 10- minutes post-treatment ]
   Subjects were asked to rate how comfortable each eye was overall on the scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable.
3. Subjective Comfort Difference Between Post-removal and Preinsertion Within Anesthetic and Cornea [ Time Frame: Immediately before lens-insertion (pre-insertion), 30 seconds after lens removal ]
   Subjects were asked to rate how comfortable each eye was overall on the scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable.

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United Kingdom

The University of Manchester

Manchester, United Kingdom, M13 9PL

Sponsors and Collaborators

Johnson & Johnson Vision Care, Inc.

  Study Documents (Full-Text)

Documents provided by Johnson & Johnson Vision Care, Inc.:

Study Protocol and Statistical Analysis Plan  [PDF] September 24, 2018

More Information

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT03733899
• Other Study ID Numbers: CR-6292
• First Posted: November 7, 2018
• Results First Posted: February 6, 2020
• Last Update Posted: March 11, 2020
• Last Verified: February 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs