Visual Acuity
Conditions
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.
Interventions
DIAGNOSTIC_TESTLocal Anesthesia
Minims Proxymetacaine hydrochloride Eye Drops
DIAGNOSTIC_TESTPlacebo
Sodium Chloride Solution
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Comfort Scores | 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. |
| Change in Subjective Comfort Scores From Pre-treatment to Post-treatment | 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. |
| Subjective Comfort Score Difference Between Post-treatment and Post-insertion Within Anesthetic | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Subjective Comfort Between Ocular Regions at Posttreatment Within Anesthetic | 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. |
| Change in Subjective Comfort From Pre-treatment to Post-Treatment Between Ocular Regions | 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. |
| Subjective Comfort Difference Between Post-removal and Preinsertion Within Anesthetic and Cornea | 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. |
Countries
United Kingdom
Participant flow
Recruitment details
A total of 22 subjects were enrolled in this study. Of those enrolled, 20 were dispensed at least one study lens while 2 subjects failed to meet all eligibility criteria. Of those dispensed, 17 completed the study while 3 subjects were discontinued.
Participants by arm
| Arm | Count |
|---|---|
| All Dispensed Subjects All subjects dispensed at least one study lens. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Period 1 | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 1 |
| Period 2 | Unscuccessful Treatment | 0 | 1 | 0 | 0 | 0 | 0 |
| Period 3 | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | All Dispensed Subjects |
|---|---|
| Age, Continuous | 26.2 Years STANDARD_DEVIATION 70 |
| Race/Ethnicity, Customized Asian | 8 Count of Participants |
| Race/Ethnicity, Customized Black or African Amercian | 2 Count of Participants |
| Race/Ethnicity, Customized White | 10 Count of Participants |
| Region of Enrollment United Kingdom | 20 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
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.
Time frame: 14-Hours upon Lens-Insertion (pre-treatment), and 10 Minutes post-treament
Population: All randomized subjects regardless of actual treatment and subsequent withdrawl from the study or deviation from protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (Anesthetic)- Cornea | Change in Subjective Comfort Scores From Pre-treatment to Post-treatment | 10- Mintues Post Treatment | 18.50 Units on a Scale | Standard Deviation 10.265 |
| Test (Anesthetic)- Cornea | Change in Subjective Comfort Scores From Pre-treatment to Post-treatment | 5- Mintues Post Treatment | 79.25 Units on a Scale | Standard Deviation 8.925 |
| Test (Anesthetic)- Cornea | Change in Subjective Comfort Scores From Pre-treatment to Post-treatment | Pre-treatment | 62.35 Units on a Scale | Standard Deviation 23.238 |
| Placebo- Cornea | Change in Subjective Comfort Scores From Pre-treatment to Post-treatment | 10- Mintues Post Treatment | 72.33 Units on a Scale | Standard Deviation 20.43 |
| Placebo- Cornea | Change in Subjective Comfort Scores From Pre-treatment to Post-treatment | 5- Mintues Post Treatment | 70.93 Units on a Scale | Standard Deviation 20.838 |
| Placebo- Cornea | Change in Subjective Comfort Scores From Pre-treatment to Post-treatment | Pre-treatment | 60.16 Units on a Scale | Standard Deviation 24.862 |
| Test (Anesthetic) - Upper Lid Margin | Change in Subjective Comfort Scores From Pre-treatment to Post-treatment | 10- Mintues Post Treatment | 65.11 Units on a Scale | Standard Deviation 21.766 |
| Test (Anesthetic) - Upper Lid Margin | Change in Subjective Comfort Scores From Pre-treatment to Post-treatment | 5- Mintues Post Treatment | 61.00 Units on a Scale | Standard Deviation 20.807 |
| Test (Anesthetic) - Upper Lid Margin | Change in Subjective Comfort Scores From Pre-treatment to Post-treatment | Pre-treatment | 56.67 Units on a Scale | Standard Deviation 24.867 |
| Placebo- Upper Lid Margin | Change in Subjective Comfort Scores From Pre-treatment to Post-treatment | 10- Mintues Post Treatment | 64.00 Units on a Scale | Standard Deviation 19.239 |
| Placebo- Upper Lid Margin | Change in Subjective Comfort Scores From Pre-treatment to Post-treatment | 5- Mintues Post Treatment | 61.94 Units on a Scale | Standard Deviation 16.783 |
| Placebo- Upper Lid Margin | Change in Subjective Comfort Scores From Pre-treatment to Post-treatment | Pre-treatment | 58.35 Units on a Scale | Standard Deviation 24.746 |
| Test (Anesthetic)- Lower Lid Margin | Change in Subjective Comfort Scores From Pre-treatment to Post-treatment | 10- Mintues Post Treatment | 70.79 Units on a Scale | Standard Deviation 16.511 |
| Test (Anesthetic)- Lower Lid Margin | Change in Subjective Comfort Scores From Pre-treatment to Post-treatment | 5- Mintues Post Treatment | 64.00 Units on a Scale | Standard Deviation 20.915 |
| Test (Anesthetic)- Lower Lid Margin | Change in Subjective Comfort Scores From Pre-treatment to Post-treatment | Pre-treatment | 60.11 Units on a Scale | Standard Deviation 24.669 |
| Placebo- Lower Lid Margin | Change in Subjective Comfort Scores From Pre-treatment to Post-treatment | 5- Mintues Post Treatment | 61.06 Units on a Scale | Standard Deviation 21.292 |
| Placebo- Lower Lid Margin | Change in Subjective Comfort Scores From Pre-treatment to Post-treatment | Pre-treatment | 57.94 Units on a Scale | Standard Deviation 21.939 |
| Placebo- Lower Lid Margin | Change in Subjective Comfort Scores From Pre-treatment to Post-treatment | 10- Mintues Post Treatment | 63.17 Units on a Scale | Standard Deviation 20.667 |
Comparison: 5-Mintues Post Treatment95% CI: [-10.3, 14.4]Linear Mixed Model
Comparison: 10-Minutes Post Treatment95% CI: [-12.1, 12.9]Linear Mixed Model
Comparison: 5-Minutes Post Treatment95% CI: [-11.4, 12.1]Linear Mixed Model
Comparison: 10-Mintues Post Treatment95% CI: [-9.2, 14]Linear Mixed Model
Comparison: 5-Mintues Post Treatment95% CI: [-8.5, 14.3]Linear Mixed Model
Comparison: 10-Mintues Post Treatment95% CI: [-3.7, 18.8]Linear Mixed Model
Primary
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.
Time frame: Immediately after lens-insertion, 5 and 10 minutes post-treatment
Population: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (Anesthetic)- Cornea | Subjective Comfort Score Difference Between Post-treatment and Post-insertion Within Anesthetic | 5-Minutes Post Treatment | 79.25 Units on a Scale | Standard Deviation 8.925 |
| Test (Anesthetic)- Cornea | Subjective Comfort Score Difference Between Post-treatment and Post-insertion Within Anesthetic | Immediate Post Lens Insertion | 78.06 Units on a Scale | Standard Deviation 17.243 |
| Test (Anesthetic)- Cornea | Subjective Comfort Score Difference Between Post-treatment and Post-insertion Within Anesthetic | 10 Minutes Post Treatment | 78.50 Units on a Scale | Standard Deviation 10.265 |
| Placebo- Cornea | Subjective Comfort Score Difference Between Post-treatment and Post-insertion Within Anesthetic | 5-Minutes Post Treatment | 61.00 Units on a Scale | Standard Deviation 20.807 |
| Placebo- Cornea | Subjective Comfort Score Difference Between Post-treatment and Post-insertion Within Anesthetic | Immediate Post Lens Insertion | 73.33 Units on a Scale | Standard Deviation 22.646 |
| Placebo- Cornea | Subjective Comfort Score Difference Between Post-treatment and Post-insertion Within Anesthetic | 10 Minutes Post Treatment | 65.11 Units on a Scale | Standard Deviation 21.766 |
| Test (Anesthetic) - Upper Lid Margin | Subjective Comfort Score Difference Between Post-treatment and Post-insertion Within Anesthetic | Immediate Post Lens Insertion | 80.37 Units on a Scale | Standard Deviation 14.064 |
| Test (Anesthetic) - Upper Lid Margin | Subjective Comfort Score Difference Between Post-treatment and Post-insertion Within Anesthetic | 10 Minutes Post Treatment | 70.79 Units on a Scale | Standard Deviation 16.511 |
| Test (Anesthetic) - Upper Lid Margin | Subjective Comfort Score Difference Between Post-treatment and Post-insertion Within Anesthetic | 5-Minutes Post Treatment | 64.00 Units on a Scale | Standard Deviation 20.915 |
Comparison: 10-Minutes Post Treatment95% CI: [-16.7, 0.2]Mixed Models Analysis
Comparison: 5-Minutes Post Treatment95% CI: [-13.2, 5.1]Mixed Models Analysis
Comparison: 10-Minutes Post Treatment95% CI: [-13.9, 5.3]Mixed Models Analysis
Comparison: 5-Minutes Post Treatment95% CI: [-24.4, -8.3]Mixed Models Analysis
Comparison: 10-Minutes Post Treatment95% CI: [-17.8, -1.4]Mixed Models Analysis
Comparison: 5-Minutes Post Treatment95% CI: [-20.6, -4.1]Mixed Models Analysis
Primary
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.
Time frame: 5 and 10 Minutes post-treament
Population: All randomized subjects regardless of actual treatment and subsequent withdrawl from the study or deviation from protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (Anesthetic)- Cornea | Subjective Comfort Scores | 5- Mintues Post Treatment | 79.25 Units on a Scale | Standard Deviation 8.925 |
| Test (Anesthetic)- Cornea | Subjective Comfort Scores | 10- Mintues Post Treatment | 18.50 Units on a Scale | Standard Deviation 10.265 |
| Placebo- Cornea | Subjective Comfort Scores | 5- Mintues Post Treatment | 70.93 Units on a Scale | Standard Deviation 20.838 |
| Placebo- Cornea | Subjective Comfort Scores | 10- Mintues Post Treatment | 72.33 Units on a Scale | Standard Deviation 20.43 |
| Test (Anesthetic) - Upper Lid Margin | Subjective Comfort Scores | 5- Mintues Post Treatment | 61.00 Units on a Scale | Standard Deviation 20.807 |
| Test (Anesthetic) - Upper Lid Margin | Subjective Comfort Scores | 10- Mintues Post Treatment | 65.11 Units on a Scale | Standard Deviation 21.766 |
| Placebo- Upper Lid Margin | Subjective Comfort Scores | 5- Mintues Post Treatment | 61.94 Units on a Scale | Standard Deviation 16.783 |
| Placebo- Upper Lid Margin | Subjective Comfort Scores | 10- Mintues Post Treatment | 64.00 Units on a Scale | Standard Deviation 19.239 |
| Test (Anesthetic)- Lower Lid Margin | Subjective Comfort Scores | 5- Mintues Post Treatment | 64.00 Units on a Scale | Standard Deviation 20.915 |
| Test (Anesthetic)- Lower Lid Margin | Subjective Comfort Scores | 10- Mintues Post Treatment | 70.79 Units on a Scale | Standard Deviation 16.511 |
| Placebo- Lower Lid Margin | Subjective Comfort Scores | 5- Mintues Post Treatment | 61.06 Units on a Scale | Standard Deviation 21.292 |
| Placebo- Lower Lid Margin | Subjective Comfort Scores | 10- Mintues Post Treatment | 63.17 Units on a Scale | Standard Deviation 20.667 |
Comparison: 5-Mintues Post Treatment95% CI: [-7.3, 12.4]Linear Mixed Model
Comparison: 10-Minutes Post Treatment95% CI: [-9.6, 11.5]Linear Mixed Model
Comparison: 5-Minutes Post Treatment95% CI: [-8.2, 9.8]Linear Mixed Model
Comparison: 10-Mintues Post Treatment95% CI: [-6.5, 12.2]Linear Mixed Model
Comparison: 5-Mintues Post Treatment95% CI: [-5.7, 11.7]Linear Mixed Model
Comparison: 10-Mintues Post Treatment95% CI: [-1.4, 16.8]Linear Mixed Model
Secondary
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.
Time frame: 5 and 10 minutes post treatment
Population: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (Anesthetic)- Cornea | Change in Subjective Comfort Between Ocular Regions at Posttreatment Within Anesthetic | 5-Minutes Post Treatment | 79.25 Units on a Scale | Standard Deviation 8.925 |
| Test (Anesthetic)- Cornea | Change in Subjective Comfort Between Ocular Regions at Posttreatment Within Anesthetic | 10 Minutes Post Treatment | 78.50 Units on a Scale | Standard Deviation 10.265 |
| Placebo- Cornea | Change in Subjective Comfort Between Ocular Regions at Posttreatment Within Anesthetic | 5-Minutes Post Treatment | 61.00 Units on a Scale | Standard Deviation 20.807 |
| Placebo- Cornea | Change in Subjective Comfort Between Ocular Regions at Posttreatment Within Anesthetic | 10 Minutes Post Treatment | 65.11 Units on a Scale | Standard Deviation 21.766 |
| Test (Anesthetic) - Upper Lid Margin | Change in Subjective Comfort Between Ocular Regions at Posttreatment Within Anesthetic | 5-Minutes Post Treatment | 64.00 Units on a Scale | Standard Deviation 20.915 |
| Test (Anesthetic) - Upper Lid Margin | Change in Subjective Comfort Between Ocular Regions at Posttreatment Within Anesthetic | 10 Minutes Post Treatment | 70.79 Units on a Scale | Standard Deviation 16.511 |
Comparison: 10-Minutes Post Treatment95% CI: [-8.7, 11.6]Mixed Models Analysis
Comparison: 5-Minutes Post Treatment95% CI: [-1, 18]Mixed Models Analysis
Comparison: 10-Minutes Post Treatment95% CI: [-3.5, 17]Mixed Models Analysis
Comparison: 5-Minutes Post Treatment95% CI: [1.6, 20.8]Mixed Models Analysis
Secondary
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.
Time frame: 14 hours upon lens-insertion (pre-treatment), 5- and 10- minutes post-treatment
Population: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (Anesthetic)- Cornea | Change in Subjective Comfort From Pre-treatment to Post-Treatment Between Ocular Regions | 5-Minutes Post Treatment | 79.25 Units on a Scale | Standard Deviation 8.925 |
| Test (Anesthetic)- Cornea | Change in Subjective Comfort From Pre-treatment to Post-Treatment Between Ocular Regions | Pre-Treatment | 62.35 Units on a Scale | Standard Deviation 23.238 |
| Test (Anesthetic)- Cornea | Change in Subjective Comfort From Pre-treatment to Post-Treatment Between Ocular Regions | 10-Minutes Post Treatment | 78.50 Units on a Scale | Standard Deviation 10.265 |
| Placebo- Cornea | Change in Subjective Comfort From Pre-treatment to Post-Treatment Between Ocular Regions | 5-Minutes Post Treatment | 61.00 Units on a Scale | Standard Deviation 20.807 |
| Placebo- Cornea | Change in Subjective Comfort From Pre-treatment to Post-Treatment Between Ocular Regions | Pre-Treatment | 56.67 Units on a Scale | Standard Deviation 24.867 |
| Placebo- Cornea | Change in Subjective Comfort From Pre-treatment to Post-Treatment Between Ocular Regions | 10-Minutes Post Treatment | 65.11 Units on a Scale | Standard Deviation 21.766 |
| Test (Anesthetic) - Upper Lid Margin | Change in Subjective Comfort From Pre-treatment to Post-Treatment Between Ocular Regions | Pre-Treatment | 60.16 Units on a Scale | Standard Deviation 24.862 |
| Test (Anesthetic) - Upper Lid Margin | Change in Subjective Comfort From Pre-treatment to Post-Treatment Between Ocular Regions | 10-Minutes Post Treatment | 70.79 Units on a Scale | Standard Deviation 16.511 |
| Test (Anesthetic) - Upper Lid Margin | Change in Subjective Comfort From Pre-treatment to Post-Treatment Between Ocular Regions | 5-Minutes Post Treatment | 64.00 Units on a Scale | Standard Deviation 20.915 |
Comparison: 10-Minutes Post Treatment95% CI: [-11.4, 12.9]Mixed Models Analysis
Comparison: 5-Minutes Post Treatment95% CI: [-4.9, 19.9]Mixed Models Analysis
Comparison: 10-Minutes Post Treatment95% CI: [-9.3, 15.2]Mixed Models Analysis
Comparison: 5-Minutes Post Treatment95% CI: [-4.9, 19.6]Mixed Models Analysis
Secondary
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.
Time frame: Immediately before lens-insertion (pre-insertion), 30 seconds after lens removal
Population: All randomized subjects regardless of actual treatment and subsequent withdrawl from study or deviation from protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (Anesthetic)- Cornea | Subjective Comfort Difference Between Post-removal and Preinsertion Within Anesthetic and Cornea | Pre-Insertion | 81.53 Units on a Scale | Standard Deviation 17.784 |
| Test (Anesthetic)- Cornea | Subjective Comfort Difference Between Post-removal and Preinsertion Within Anesthetic and Cornea | Post-Removal | 69.12 Units on a Scale | Standard Deviation 21.508 |
95% CI: [-20.9, -3.9]Mixed Models Analysis