Myopia
Conditions
Brief summary
This was be a randomized, contralateral, double-masked, dispensing study comparing the Study test lens against the control lens over one month of lens wear. The study results were not used for design validation of test lens.
Detailed description
Subjects were randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses were used in a daily wear modality for one month. The study results were not used for design validation of test lens.
Interventions
DEVICESapphire Lens
Each subject will be randomized to wear the test lens on one eye and control lens on one eye.
DEVICEenfilcon A
Each subject will be randomized to wear the test lens on one eye and control lens on one eye.
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects will only be eligible for the study if: 1. Is at least 18 years of age for the USA 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 an adapted soft contact lens wearer; 5. Requires spectacle lens powers between -0.50 to -6.50 diopters sphere; 6. Has no more than 0.75 diopters of refractive astigmatism; 7. Willing to wear contact lens in both eyes; 8. Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye; 9. To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit as acceptable.
Exclusion criteria
* Subjects will not be eligible to take part in the study if: 1. Is participating in any concurrent clinical or research 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. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit); 7. Is aphakic; 8. 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 |
|---|---|---|
| Subjective Ratings for Comfort After Lens Insertion | Baseline (5 minutes post lens dispensing) | Subjective ratings for comfort on a scale (0-100) assessed : 0= Cannot be worn, causes pain, 20=Frequently irritating, 40= Occasionally irritating, 60= Occasionally noticable but not irritating, 80= rarely noticeable, 100= cannot be felt ever |
| Percentage of Participants With a Lens Preference Based on Subjective Comfort | Baseline (5 minutes post lens dispensing) | Percentage of Participants with a Lens Preference Based on Subjective Comfort. Preferred Sapphire, Preferred Enfilcon A, No preference |
| Lens Wettability | Baseline (5 minutes post lens dispensing) | Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced) |
| Lens Surface Deposition | Baseline (5 minutes post lens dispensing) | Lens Surface Deposit was assessed on a scale of 0-4 (0-4, 0.25 steps)(0- Clean , no deposits, 1- 5 or less small deposits (\<0.1mm), 2- \>5 deposits of \<0.1mm size or film covering 25-50% of surface, 3 - Deposits of between 0.1 and 0.5amm or film covering 50-75% of surface, 4- Deposits of 0.5mm or larger or film covering more than 75% of surface) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Subjects were randomized to wear test lens in one eye and control lens in other eye for a one month period. | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 17 Participants | — |
| Age, Continuous | 29 years STANDARD_DEVIATION 12 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 17 participants | — |
| Sex: Female, Male Female | 14 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 / 18 | 0 / 18 |
| other Total, other adverse events | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
Primary
Lens Surface Deposition
Lens Surface Deposit was assessed on a scale of 0-4 (0-4, 0.25 steps)(0- Clean , no deposits, 1- 5 or less small deposits (\<0.1mm), 2- \>5 deposits of \<0.1mm size or film covering 25-50% of surface, 3 - Deposits of between 0.1 and 0.5amm or film covering 50-75% of surface, 4- Deposits of 0.5mm or larger or film covering more than 75% of surface)
Time frame: Baseline (5 minutes post lens dispensing)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sapphire Lenses | Lens Surface Deposition | 0.06 units on a scale | Standard Deviation 0.17 |
| Enfilcon A | Lens Surface Deposition | 0.03 units on a scale | Standard Deviation 0.12 |
Primary
Lens Surface Deposition
Lens Surface Deposit was assessed on a scale of 0-4 (0-4, 0.25 steps)(0- Clean , no deposits, 1- 5 or less small deposits (\<0.1mm), 2- \>5 deposits of \<0.1mm size or film covering 25-50% of surface, 3 - Deposits of between 0.1 and 0.5amm or film covering 50-75% of surface, 4- Deposits of 0.5mm or larger or film covering more than 75% of surface)
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sapphire Lenses | Lens Surface Deposition | 0.21 units on a scale | Standard Deviation 0.5 |
| Enfilcon A | Lens Surface Deposition | 0.10 units on a scale | Standard Deviation 0.27 |
Primary
Lens Wettability
Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced)
Time frame: Baseline (5 minutes post lens dispensing)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sapphire Lenses | Lens Wettability | 3.4 units on a scale | Standard Deviation 0.4 |
| Enfilcon A | Lens Wettability | 3.4 units on a scale | Standard Deviation 0.3 |
Primary
Lens Wettability
Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced)
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sapphire Lenses | Lens Wettability | 3.5 units on a scale | Standard Deviation 0.4 |
| Enfilcon A | Lens Wettability | 3.6 units on a scale | Standard Deviation 0.3 |
Primary
Percentage of Participants With a Lens Preference Based on Subjective Comfort
Percentage of Participants with a Lens Preference Based on Subjective Comfort. Preferred Sapphire, Preferred Enfilcon A, No preference
Time frame: Baseline (5 minutes post lens dispensing)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sapphire Lenses | Percentage of Participants With a Lens Preference Based on Subjective Comfort | Sapphire | 20 percentage of participants |
| Sapphire Lenses | Percentage of Participants With a Lens Preference Based on Subjective Comfort | No preference | 30 percentage of participants |
| Sapphire Lenses | Percentage of Participants With a Lens Preference Based on Subjective Comfort | enfilcon A | 50 percentage of participants |
Primary
Percentage of Participants With a Lens Preference Based on Subjective Comfort
Percentage of Participants with a Lens Preference Based on Subjective Comfort. Preferred Sapphire, Preferred Enfilcon A, No preference
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sapphire Lenses | Percentage of Participants With a Lens Preference Based on Subjective Comfort | Sapphire | 10 percentage of participants |
| Sapphire Lenses | Percentage of Participants With a Lens Preference Based on Subjective Comfort | No preference | 65 percentage of participants |
| Sapphire Lenses | Percentage of Participants With a Lens Preference Based on Subjective Comfort | enfilcon A | 25 percentage of participants |
Primary
Subjective Ratings for Comfort After Lens Insertion
Subjective ratings for comfort on a scale (0-100) assessed : 0= Cannot be worn, causes pain, 20=Frequently irritating, 40= Occasionally irritating, 60= Occasionally noticable but not irritating, 80= rarely noticeable, 100= cannot be felt ever
Time frame: Baseline (5 minutes post lens dispensing)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sapphire Lenses | Subjective Ratings for Comfort After Lens Insertion | 91 units on a scale | Standard Deviation 11 |
| Enfilcon A | Subjective Ratings for Comfort After Lens Insertion | 93 units on a scale | Standard Deviation 12 |
Primary
Subjective Ratings for Comfort After Lens Insertion
Subjective ratings for comfort on a scale (0-100) assessed : 0= Cannot be worn, causes pain, 20=Frequently irritating, 40= Occasionally irritating, 60= Occasionally noticable but not irritating, 80= rarely noticeable, 100= cannot be felt ever
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sapphire Lenses | Subjective Ratings for Comfort After Lens Insertion | 88 units on a scale | Standard Deviation 11 |
| Enfilcon A | Subjective Ratings for Comfort After Lens Insertion | 87 units on a scale | Standard Deviation 15 |