Myopia
Conditions
Brief summary
The study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses.
Detailed description
The study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses. The primary outcome variable for this study is the loss in lens weight over the day, which will indicate the amount of dehydration that has occured.
Interventions
DEVICEstenfilcon A
Each subject randomized to wear either the test or control in either the left of right eye.
DEVICEdelefilcon A
Each subject randomized to wear either the test or control in either the left of right eye.
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Is at least 17 years of age and has full legal capacity to volunteer; 2. Has read and signed an information consent letter; 3. Is willing and able to follow instructions and maintain the appointment schedule; 4. Is a current wearer of soft contact lenses and has worn them (any brand) more than 3 months. 5. Is able to wear lenses for at least 12 hours a day.
Exclusion criteria
1. Is participating in any concurrent clinical study; 2. Has any known active\* ocular disease and/or infection; 3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; 4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; 5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study; 6. Has undergone refractive error surgery; * \*For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change in Water Content (Mean) of Stenfilcon A and Delefilcon A | 12 Hours of Wear | Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC). |
| Absolute Change in Water Content (Median) of Stenfilcon A and Delefilcon A | 12 Hours of Wear | Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC). |
| Moisture Retention (Mean) of Stenfilcon A and Delefilcon A | 12 Hours of Wear | Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD). |
| Moisture Retention (Median) of Stenfilcon A and Delefilcon A | 12 Hours of Wear | Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Comfort of Stenfilcon A and Delefilcon A | Up to 12 Hours of Wear | Subjective ratings for stenfilcon A and delefilcon A assessed at every hour up to 12 hours. (Scale 0-100, 0=very poor 100=excellent) |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Participants Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table.
stenfilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table
delefilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | High Astigmatism | 3 |
| Overall Study | Positive Slit Lamp Findings | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Overall Participants |
|---|---|
| Age, Continuous | 25 years |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
Primary
Absolute Change in Water Content (Mean) of Stenfilcon A and Delefilcon A
Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).
Time frame: 12 Hours of Wear
Population: There were outliers across four participants in five lenses due to the fact that the weight of the worn lens after 12 hours was greater than the baseline weight of the lens from the blister pack. The sample size for statistical analysis is reduced to 18 pairs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A | Absolute Change in Water Content (Mean) of Stenfilcon A and Delefilcon A | 2.82 absolute WC change | Standard Deviation 1.31 |
| Delefilcon A | Absolute Change in Water Content (Mean) of Stenfilcon A and Delefilcon A | 2.91 absolute WC change | Standard Deviation 2.31 |
Primary
Absolute Change in Water Content (Median) of Stenfilcon A and Delefilcon A
Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).
Time frame: 12 Hours of Wear
Population: There were outliers across four participants in five lenses due to the fact that the weight of the worn lens after 12 hours was greater than the baseline weight of the lens from the blister pack. The sample size for statistical analysis is reduced to 18 pairs.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stenfilcon A | Absolute Change in Water Content (Median) of Stenfilcon A and Delefilcon A | 2.76 absolute WC change |
| Delefilcon A | Absolute Change in Water Content (Median) of Stenfilcon A and Delefilcon A | 2.35 absolute WC change |
Primary
Moisture Retention (Mean) of Stenfilcon A and Delefilcon A
Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).
Time frame: 12 Hours of Wear
Population: There were outliers across four participants in five lenses due to the fact that the weight of the worn lens after 12 hours was greater than the baseline weight of the lens from the blister pack. The sample size for statistical analysis is reduced to 18 pairs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A | Moisture Retention (Mean) of Stenfilcon A and Delefilcon A | 5.22 percentage of dehyrdation | Standard Deviation 2.42 |
| Delefilcon A | Moisture Retention (Mean) of Stenfilcon A and Delefilcon A | 9.21 percentage of dehyrdation | Standard Deviation 7.38 |
Primary
Moisture Retention (Median) of Stenfilcon A and Delefilcon A
Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).
Time frame: 12 Hours of Wear
Population: There were outliers across four participants in five lenses due to the fact that the weight of the worn lens after 12 hours was greater than the baseline weight of the lens from the blister pack. The sample size for statistical analysis is reduced to 18 pairs.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stenfilcon A | Moisture Retention (Median) of Stenfilcon A and Delefilcon A | 5.15 percentage of dehyrdation |
| Delefilcon A | Moisture Retention (Median) of Stenfilcon A and Delefilcon A | 7.41 percentage of dehyrdation |
Secondary
Subjective Comfort of Stenfilcon A and Delefilcon A
Subjective ratings for stenfilcon A and delefilcon A assessed at every hour up to 12 hours. (Scale 0-100, 0=very poor 100=excellent)
Time frame: Up to 12 Hours of Wear
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stenfilcon A | Subjective Comfort of Stenfilcon A and Delefilcon A | 2 HR | 90.9 units on a scale | Standard Deviation 8.8 |
| Stenfilcon A | Subjective Comfort of Stenfilcon A and Delefilcon A | 7 HR | 86.8 units on a scale | Standard Deviation 10.4 |
| Stenfilcon A | Subjective Comfort of Stenfilcon A and Delefilcon A | 4 HR | 89.7 units on a scale | Standard Deviation 9.3 |
| Stenfilcon A | Subjective Comfort of Stenfilcon A and Delefilcon A | 8 HR | 84.7 units on a scale | Standard Deviation 10.5 |
| Stenfilcon A | Subjective Comfort of Stenfilcon A and Delefilcon A | 1 HR | 90.5 units on a scale | Standard Deviation 8.4 |
| Stenfilcon A | Subjective Comfort of Stenfilcon A and Delefilcon A | 9 HR | 83.0 units on a scale | Standard Deviation 11.6 |
| Stenfilcon A | Subjective Comfort of Stenfilcon A and Delefilcon A | 5 HR | 89.1 units on a scale | Standard Deviation 9.5 |
| Stenfilcon A | Subjective Comfort of Stenfilcon A and Delefilcon A | 10 HR | 80.9 units on a scale | Standard Deviation 12 |
| Stenfilcon A | Subjective Comfort of Stenfilcon A and Delefilcon A | 3 HR | 89.8 units on a scale | Standard Deviation 10.9 |
| Stenfilcon A | Subjective Comfort of Stenfilcon A and Delefilcon A | 11 HR | 78.0 units on a scale | Standard Deviation 14.8 |
| Stenfilcon A | Subjective Comfort of Stenfilcon A and Delefilcon A | 6 HR | 87.5 units on a scale | Standard Deviation 10.4 |
| Stenfilcon A | Subjective Comfort of Stenfilcon A and Delefilcon A | 12 HR | 75.5 units on a scale | Standard Deviation 16.2 |
| Stenfilcon A | Subjective Comfort of Stenfilcon A and Delefilcon A | 0 HR | 92.0 units on a scale | Standard Deviation 11.5 |
| Delefilcon A | Subjective Comfort of Stenfilcon A and Delefilcon A | 12 HR | 81.1 units on a scale | Standard Deviation 14.7 |
| Delefilcon A | Subjective Comfort of Stenfilcon A and Delefilcon A | 0 HR | 93.9 units on a scale | Standard Deviation 8.4 |
| Delefilcon A | Subjective Comfort of Stenfilcon A and Delefilcon A | 1 HR | 92.8 units on a scale | Standard Deviation 8.6 |
| Delefilcon A | Subjective Comfort of Stenfilcon A and Delefilcon A | 2 HR | 93.6 units on a scale | Standard Deviation 6.2 |
| Delefilcon A | Subjective Comfort of Stenfilcon A and Delefilcon A | 3 HR | 92.7 units on a scale | Standard Deviation 7 |
| Delefilcon A | Subjective Comfort of Stenfilcon A and Delefilcon A | 4 HR | 91.8 units on a scale | Standard Deviation 8 |
| Delefilcon A | Subjective Comfort of Stenfilcon A and Delefilcon A | 5 HR | 90.6 units on a scale | Standard Deviation 8.4 |
| Delefilcon A | Subjective Comfort of Stenfilcon A and Delefilcon A | 6 HR | 91.8 units on a scale | Standard Deviation 7.8 |
| Delefilcon A | Subjective Comfort of Stenfilcon A and Delefilcon A | 7 HR | 89.5 units on a scale | Standard Deviation 10 |
| Delefilcon A | Subjective Comfort of Stenfilcon A and Delefilcon A | 8 HR | 87.2 units on a scale | Standard Deviation 10.7 |
| Delefilcon A | Subjective Comfort of Stenfilcon A and Delefilcon A | 9 HR | 85.6 units on a scale | Standard Deviation 12.6 |
| Delefilcon A | Subjective Comfort of Stenfilcon A and Delefilcon A | 10 HR | 83.9 units on a scale | Standard Deviation 13.4 |
| Delefilcon A | Subjective Comfort of Stenfilcon A and Delefilcon A | 11 HR | 81.4 units on a scale | Standard Deviation 15.2 |