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

Study Overview
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Brief Summary
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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.

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

Conditions
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Visual Acuity

Intervention / Treatment
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* Diagnostic Test: Local Anesthesia
* Diagnostic Test: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Potential subjects must satisfy all of the following criteria to be enrolled in the study: They are of legal age (18 years) and capacity of volunteer. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. They must appear able and willing to adhere to the instructions set forth in this clinical protocol. They have worn the same brand of soft spherical contact lenses for at least the previous three months, by self-report. They are defined as 'symptomatic' contact lens wearers (CLDEQ-8 score of 20-37) with their habitual contact lenses. They are willing to wear their lenses for approximately 14 hours on study days. They have a wearable pair of spectacles, if applicable. They agree not to participate in other clinical research for the duration of this study. 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: They have an ocular disorder, which would normally contra-indicate contact lens wear. They have a systemic disorder, which would normally contra-indicate contact lens wear. They are using any topical medication such as eye drops or ointment. They have had cataract or corneal refractive surgery. They are pregnant or breast-feeding by self-report. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV), by self-report. They have any known hypersensitivity or allergic reaction to any of the known ingredients in the anesthetic. They have a history of severe allergic reaction or anaphylaxis. They have a history of cardiac disease or hyperthyroidism. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study. They are an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician). They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Upper lid margin/Lower lid margin/Cornea<br>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<br>* Minims Proxymetacaine hydrochloride Eye Drops<br>Diagnostic Test: Placebo<br>* Sodium Chloride Solution<br>|
| Experimental: Lower lid margin/Cornea/ Upper lid margin<br>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<br>* Minims Proxymetacaine hydrochloride Eye Drops<br>Diagnostic Test: Placebo<br>* Sodium Chloride Solution<br>|
| Experimental: Cornea/Upper lid margin/Lower lid margin<br>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<br>* Minims Proxymetacaine hydrochloride Eye Drops<br>Diagnostic Test: Placebo<br>* Sodium Chloride Solution<br>|
| Experimental: Cornea/Lower lid margin/Upper lid margin<br>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<br>* Minims Proxymetacaine hydrochloride Eye Drops<br>Diagnostic Test: Placebo<br>* Sodium Chloride Solution<br>|
| Experimental: Upper lid margin/Cornea/Lower lid margin<br>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<br>* Minims Proxymetacaine hydrochloride Eye Drops<br>Diagnostic Test: Placebo<br>* Sodium Chloride Solution<br>|
| Experimental: Lower lid margin/Upper lid margin/Cornea<br>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<br>* Minims Proxymetacaine hydrochloride Eye Drops<br>Diagnostic Test: Placebo<br>* Sodium Chloride Solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Comfort Scores | 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. | 5 and 10 Minutes post-treament | 
| Change in Subjective Comfort Scores From Pre-treatment to Post-treatment | 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. | 14-Hours upon Lens-Insertion (pre-treatment), and 10 Minutes post-treament | 
| Subjective Comfort Score Difference Between Post-treatment and Post-insertion Within Anesthetic | 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. | Immediately after lens-insertion, 5 and 10 minutes post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Subjective Comfort Between Ocular Regions at Posttreatment Within Anesthetic | 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. | 5 and 10 minutes post treatment | 
| Change in Subjective Comfort From Pre-treatment to Post-Treatment Between Ocular Regions | 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. | 14 hours upon lens-insertion (pre-treatment), 5- and 10- minutes post-treatment | 
| Subjective Comfort Difference Between Post-removal and Preinsertion Within Anesthetic and Cornea | 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. | Immediately before lens-insertion (pre-insertion), 30 seconds after lens removal |