Myopia
Conditions
Brief summary
This will be a controlled and randomized, single-masked, crossover study in which 48 subjects will use the Biofinity Contact Lens (comfilcon A) with each of the two lens care products ('solutions'), (Synergi and Biotrue Multi-purpose Solution) for one month each. Follow-up visits for each solution will take place at one week, two weeks and four weeks: with a one-week 'wash-out' period between the solutions. Key outcome measures for this study include biomicroscopic and subjective responses to the lens/solution combinations.
Interventions
DEVICEcomfilcon A
soft contact lens
DEVICESynergi
Multipurpose solution
DEVICEBiotrue
Multipurpose solution
OTHERstenfilcon A
daily disposable contact lenses for washout period
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. They are of legal age and capacity to volunteer. 2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent. 3. They are willing and able to follow the protocol. 4. They agree not to participate in other clinical research for the duration of this study. 5. They have a contact lens spherical prescription between - 0.50 to - 6.00 (inclusive) 6. They have a spectacle cylindrical correction of -1.00D (Diopters) or less in each eye. 7. At dispensing, they can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range. 8. They currently use silicone hydrogel soft contact lenses. 9. They are willing to comply with the wear schedule (at least 5 days per week, ≥8 hours/day).
Exclusion criteria
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 surgery. 5. They have had corneal refractive surgery. 6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. 7. They are pregnant or lactating. 8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear. 9. They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conjunctival Hyperaemia | Baseline, 1 week, 2 weeks, 4 weeks | Conjunctival hyperaemia of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe. |
| Limbal Hyperaemia | Baseline, 1 week, 2 weeks, 4 weeks | Limbal hyperaemia of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe. |
| Corneal Staining | Baseline, 1 week, 2 weeks, 4 weeks | Corneal staining of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=none, 4=patch. |
| Papillary Conjunctivitis | Baseline, 1 week, 2 weeks, 4 weeks | Papillary conjunctivitis of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe. |
| Comfort | 1 week | Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 1 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt. |
| Vision | 1 week | Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision. |
| Ease of Use of Solution | 1 week, 2 weeks, 4 weeks | Subjective ease of use for Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visit. Scale 0-100, 0=very difficult, 100=very easy |
| Dryness | 1 week, 2 weeks, 4 weeks | Subjective assessment of dryness for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week visit. Scale 0-100, 0=extremely dry 100=not dry at all. |
| Burning/Stinging | 1 week, 2 weeks, 4 weeks | Subjective assessment of burning/stinging for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week visit. Scale 0-100, 0=Extreme stinging / burning, 100=No stinging / burning sensation. |
| Ocular Redness | 1 week, 2 weeks, 4 weeks | Subjective ocular redness of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=extremely poor. intolerable levels of redness, 100=excellent, no redness. |
| Ease of Lens Insertion | 1 week, 2 weeks, 4 weeks | Subjective assessment of insertionfor Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=unmanageable. lenses impossible to insert, 100=excellent. no problem with lens insertion. |
| Ease of Lens Removal | 1 week, 2 weeks, 4 weeks | Subjective assessment of removal for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=unmanageable. lenses impossible to remove, 100=excellent. no problem with lens remove. |
| Overall Score | 1 week, 2 weeks, 4 weeks | Subjective overall scores Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visit. Scale 0-100, 0=extremely poor, 100=excellent, highly impressed. |
Countries
United Kingdom
Participant flow
Pre-assignment details
Three subjects were not dispensed the combination of multipurpose solutions.
Participants by arm
| Arm | Count |
|---|---|
| Overall Baseline Characteristics Participants were randomized to wear either the Synergi/comfilcon A or Biotrue/comfilcon A combination for one month, then cross over to the alternative combination. | 51 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (4 Weeks) | Withdrawal by Subject | 0 | 1 |
| Second Intervention (4 Weeks) | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Overall Baseline Characteristics |
|---|---|
| Age, Continuous | 33.3 years STANDARD_DEVIATION 10.9 |
| Region of Enrollment United Kingdom | 51 participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 27 |
| serious Total, serious adverse events | 0 / 21 | 0 / 27 |
Outcome results
Primary
Burning/Stinging
Subjective assessment of burning/stinging for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week visit. Scale 0-100, 0=Extreme stinging / burning, 100=No stinging / burning sensation.
Time frame: 1 week, 2 weeks, 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Synergi / Comfilcon A | Burning/Stinging | 1 week | 94.3 units on a scale | Standard Deviation 13 |
| Synergi / Comfilcon A | Burning/Stinging | 2 weeks | 96.0 units on a scale | Standard Deviation 8.4 |
| Synergi / Comfilcon A | Burning/Stinging | 4 weeks | 94.6 units on a scale | Standard Deviation 10.9 |
| Biotrue / Comfilcon A | Burning/Stinging | 1 week | 95.7 units on a scale | Standard Deviation 9.4 |
| Biotrue / Comfilcon A | Burning/Stinging | 2 weeks | 96.8 units on a scale | Standard Deviation 8.7 |
| Biotrue / Comfilcon A | Burning/Stinging | 4 weeks | 96.5 units on a scale | Standard Deviation 9.3 |
Primary
Comfort
Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 4 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.
Time frame: 4 weeks
Population: The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Synergi / Comfilcon A | Comfort | Comfort after insertion | 88.3 units on a scale | Standard Deviation 11 |
| Synergi / Comfilcon A | Comfort | Comfort before removal | 76.1 units on a scale | Standard Deviation 21.2 |
| Synergi / Comfilcon A | Comfort | Overall comfort | 85.3 units on a scale | Standard Deviation 14.3 |
| Biotrue / Comfilcon A | Comfort | Comfort after insertion | 87.3 units on a scale | Standard Deviation 15.5 |
| Biotrue / Comfilcon A | Comfort | Comfort before removal | 75.0 units on a scale | Standard Deviation 20 |
| Biotrue / Comfilcon A | Comfort | Overall comfort | 84.5 units on a scale | Standard Deviation 14 |
Primary
Comfort
Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 2 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.
Time frame: 2 weeks
Population: The difference in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Synergi / Comfilcon A | Comfort | Comfort after insertion | 87.0 units on a scale | Standard Deviation 12.6 |
| Synergi / Comfilcon A | Comfort | Comfort before removal | 78.1 units on a scale | Standard Deviation 19.4 |
| Synergi / Comfilcon A | Comfort | Overall comfort | 84.7 units on a scale | Standard Deviation 14.9 |
| Biotrue / Comfilcon A | Comfort | Comfort after insertion | 85.6 units on a scale | Standard Deviation 14.8 |
| Biotrue / Comfilcon A | Comfort | Comfort before removal | 73.9 units on a scale | Standard Deviation 20.9 |
| Biotrue / Comfilcon A | Comfort | Overall comfort | 83.2 units on a scale | Standard Deviation 14.8 |
Primary
Comfort
Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 1 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.
Time frame: 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Synergi / Comfilcon A | Comfort | Comfort after insertion | 88.7 units on a scale | Standard Deviation 11.4 |
| Synergi / Comfilcon A | Comfort | Comfort before removal | 76.8 units on a scale | Standard Deviation 17.2 |
| Synergi / Comfilcon A | Comfort | Overall comfort | 85.6 units on a scale | Standard Deviation 11.8 |
| Biotrue / Comfilcon A | Comfort | Comfort after insertion | 83.4 units on a scale | Standard Deviation 17.9 |
| Biotrue / Comfilcon A | Comfort | Comfort before removal | 72.4 units on a scale | Standard Deviation 22.4 |
| Biotrue / Comfilcon A | Comfort | Overall comfort | 82.8 units on a scale | Standard Deviation 13.9 |
Primary
Conjunctival Hyperaemia
Conjunctival hyperaemia of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.
Time frame: Baseline, 1 week, 2 weeks, 4 weeks
Population: The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Synergi / Comfilcon A | Conjunctival Hyperaemia | Baseline | 0.84 units on a scale | Standard Deviation 0.24 |
| Synergi / Comfilcon A | Conjunctival Hyperaemia | 1 week | 0.87 units on a scale | Standard Deviation 0.21 |
| Synergi / Comfilcon A | Conjunctival Hyperaemia | 2 weeks | 0.88 units on a scale | Standard Deviation 0.24 |
| Synergi / Comfilcon A | Conjunctival Hyperaemia | 4 weeks | 0.90 units on a scale | Standard Deviation 0.21 |
| Biotrue / Comfilcon A | Conjunctival Hyperaemia | 4 weeks | 0.82 units on a scale | Standard Deviation 0.17 |
| Biotrue / Comfilcon A | Conjunctival Hyperaemia | Baseline | 0.87 units on a scale | Standard Deviation 0.21 |
| Biotrue / Comfilcon A | Conjunctival Hyperaemia | 2 weeks | 0.83 units on a scale | Standard Deviation 0.21 |
| Biotrue / Comfilcon A | Conjunctival Hyperaemia | 1 week | 0.87 units on a scale | Standard Deviation 0.22 |
Primary
Corneal Staining
Corneal staining of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=none, 4=patch.
Time frame: Baseline, 1 week, 2 weeks, 4 weeks
Population: The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Synergi / Comfilcon A | Corneal Staining | Baseline | 0.30 units on a scale | Standard Deviation 0.48 |
| Synergi / Comfilcon A | Corneal Staining | 1 week | 0.34 units on a scale | Standard Deviation 0.4 |
| Synergi / Comfilcon A | Corneal Staining | 2 weeks | 0.38 units on a scale | Standard Deviation 0.46 |
| Synergi / Comfilcon A | Corneal Staining | 4 weeks | 0.31 units on a scale | Standard Deviation 0.42 |
| Biotrue / Comfilcon A | Corneal Staining | 4 weeks | 0.62 units on a scale | Standard Deviation 0.51 |
| Biotrue / Comfilcon A | Corneal Staining | Baseline | 0.17 units on a scale | Standard Deviation 0.34 |
| Biotrue / Comfilcon A | Corneal Staining | 2 weeks | 0.59 units on a scale | Standard Deviation 0.54 |
| Biotrue / Comfilcon A | Corneal Staining | 1 week | 0.67 units on a scale | Standard Deviation 0.47 |
Primary
Dryness
Subjective assessment of dryness for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week visit. Scale 0-100, 0=extremely dry 100=not dry at all.
Time frame: 1 week, 2 weeks, 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Synergi / Comfilcon A | Dryness | 1 week | 82.8 units on a scale | Standard Deviation 16.3 |
| Synergi / Comfilcon A | Dryness | 2 weeks | 79.5 units on a scale | Standard Deviation 20.5 |
| Synergi / Comfilcon A | Dryness | 4 weeks | 79.9 units on a scale | Standard Deviation 20.9 |
| Biotrue / Comfilcon A | Dryness | 1 week | 79.3 units on a scale | Standard Deviation 20 |
| Biotrue / Comfilcon A | Dryness | 2 weeks | 80.2 units on a scale | Standard Deviation 19.8 |
| Biotrue / Comfilcon A | Dryness | 4 weeks | 81.7 units on a scale | Standard Deviation 20.3 |
Primary
Ease of Lens Insertion
Subjective assessment of insertionfor Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=unmanageable. lenses impossible to insert, 100=excellent. no problem with lens insertion.
Time frame: 1 week, 2 weeks, 4 weeks
Population: The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Synergi / Comfilcon A | Ease of Lens Insertion | 1 week | 90.9 units on a scale | Standard Deviation 11.8 |
| Synergi / Comfilcon A | Ease of Lens Insertion | 2 weeks | 90.8 units on a scale | Standard Deviation 8.8 |
| Synergi / Comfilcon A | Ease of Lens Insertion | 4 weeks | 91.8 units on a scale | Standard Deviation 8.7 |
| Biotrue / Comfilcon A | Ease of Lens Insertion | 1 week | 93.2 units on a scale | Standard Deviation 8.5 |
| Biotrue / Comfilcon A | Ease of Lens Insertion | 2 weeks | 93.4 units on a scale | Standard Deviation 8.9 |
| Biotrue / Comfilcon A | Ease of Lens Insertion | 4 weeks | 93.5 units on a scale | Standard Deviation 8.8 |
Primary
Ease of Lens Removal
Subjective assessment of removal for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=unmanageable. lenses impossible to remove, 100=excellent. no problem with lens remove.
Time frame: 1 week, 2 weeks, 4 weeks
Population: The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Synergi / Comfilcon A | Ease of Lens Removal | 1 week | 91.1 units on a scale | Standard Deviation 14 |
| Synergi / Comfilcon A | Ease of Lens Removal | 2 weeks | 90.7 units on a scale | Standard Deviation 11.9 |
| Synergi / Comfilcon A | Ease of Lens Removal | 4 weeks | 91.3 units on a scale | Standard Deviation 11.2 |
| Biotrue / Comfilcon A | Ease of Lens Removal | 1 week | 92.2 units on a scale | Standard Deviation 11.8 |
| Biotrue / Comfilcon A | Ease of Lens Removal | 2 weeks | 94.0 units on a scale | Standard Deviation 10.5 |
| Biotrue / Comfilcon A | Ease of Lens Removal | 4 weeks | 94.4 units on a scale | Standard Deviation 8.2 |
Primary
Ease of Use of Solution
Subjective ease of use for Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visit. Scale 0-100, 0=very difficult, 100=very easy
Time frame: 1 week, 2 weeks, 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Synergi / Comfilcon A | Ease of Use of Solution | 1 week | 87.7 units on a scale | Standard Deviation 17.3 |
| Synergi / Comfilcon A | Ease of Use of Solution | 2 weeks | 88.2 units on a scale | Standard Deviation 17.5 |
| Synergi / Comfilcon A | Ease of Use of Solution | 4 weeks | 88.7 units on a scale | Standard Deviation 15.3 |
| Biotrue / Comfilcon A | Ease of Use of Solution | 1 week | 92.2 units on a scale | Standard Deviation 11.4 |
| Biotrue / Comfilcon A | Ease of Use of Solution | 2 weeks | 93.6 units on a scale | Standard Deviation 11 |
| Biotrue / Comfilcon A | Ease of Use of Solution | 4 weeks | 92.7 units on a scale | Standard Deviation 12.6 |
Primary
Limbal Hyperaemia
Limbal hyperaemia of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.
Time frame: Baseline, 1 week, 2 weeks, 4 weeks
Population: The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Synergi / Comfilcon A | Limbal Hyperaemia | Baseline | 0.73 units on a scale | Standard Deviation 0.26 |
| Synergi / Comfilcon A | Limbal Hyperaemia | 1 week | 0.80 units on a scale | Standard Deviation 0.23 |
| Synergi / Comfilcon A | Limbal Hyperaemia | 2 weeks | 0.73 units on a scale | Standard Deviation 0.25 |
| Synergi / Comfilcon A | Limbal Hyperaemia | 4 weeks | 0.78 units on a scale | Standard Deviation 0.22 |
| Biotrue / Comfilcon A | Limbal Hyperaemia | 4 weeks | 0.72 units on a scale | Standard Deviation 0.21 |
| Biotrue / Comfilcon A | Limbal Hyperaemia | Baseline | 0.77 units on a scale | Standard Deviation 0.22 |
| Biotrue / Comfilcon A | Limbal Hyperaemia | 2 weeks | 0.70 units on a scale | Standard Deviation 0.26 |
| Biotrue / Comfilcon A | Limbal Hyperaemia | 1 week | 0.75 units on a scale | Standard Deviation 0.24 |
Primary
Ocular Redness
Subjective ocular redness of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=extremely poor. intolerable levels of redness, 100=excellent, no redness.
Time frame: 1 week, 2 weeks, 4 weeks
Population: The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Synergi / Comfilcon A | Ocular Redness | 1 week | 96.0 units on a scale | Standard Deviation 9.9 |
| Synergi / Comfilcon A | Ocular Redness | 2 weeks | 95.4 units on a scale | Standard Deviation 9.6 |
| Synergi / Comfilcon A | Ocular Redness | 4 weeks | 95.5 units on a scale | Standard Deviation 8.1 |
| Biotrue / Comfilcon A | Ocular Redness | 1 week | 96.8 units on a scale | Standard Deviation 6.4 |
| Biotrue / Comfilcon A | Ocular Redness | 2 weeks | 96.5 units on a scale | Standard Deviation 8.2 |
| Biotrue / Comfilcon A | Ocular Redness | 4 weeks | 95.7 units on a scale | Standard Deviation 9.9 |
Primary
Overall Score
Subjective overall scores Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visit. Scale 0-100, 0=extremely poor, 100=excellent, highly impressed.
Time frame: 1 week, 2 weeks, 4 weeks
Population: Data not collected as follows: 2 weeks (1 participant) and 4 weeks (1 participant - Synergi, 1 participant - Biotrue).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Synergi / Comfilcon A | Overall Score | 1 week | 90.3 units on a scale | Standard Deviation 12.6 |
| Synergi / Comfilcon A | Overall Score | 2 weeks | 88.3 units on a scale | Standard Deviation 15 |
| Synergi / Comfilcon A | Overall Score | 4 weeks | 88.8 units on a scale | Standard Deviation 15.4 |
| Biotrue / Comfilcon A | Overall Score | 1 week | 90.6 units on a scale | Standard Deviation 11.7 |
| Biotrue / Comfilcon A | Overall Score | 2 weeks | 90.7 units on a scale | Standard Deviation 12.5 |
| Biotrue / Comfilcon A | Overall Score | 4 weeks | 91.7 units on a scale | Standard Deviation 12.7 |
Primary
Papillary Conjunctivitis
Papillary conjunctivitis of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.
Time frame: Baseline, 1 week, 2 weeks, 4 weeks
Population: The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Synergi / Comfilcon A | Papillary Conjunctivitis | Baseline | 1.04 units on a scale | Standard Deviation 0.22 |
| Synergi / Comfilcon A | Papillary Conjunctivitis | 1 week | 1.05 units on a scale | Standard Deviation 0.24 |
| Synergi / Comfilcon A | Papillary Conjunctivitis | 2 weeks | 1.05 units on a scale | Standard Deviation 0.26 |
| Synergi / Comfilcon A | Papillary Conjunctivitis | 4 weeks | 1.09 units on a scale | Standard Deviation 0.24 |
| Biotrue / Comfilcon A | Papillary Conjunctivitis | 4 weeks | 1.06 units on a scale | Standard Deviation 0.24 |
| Biotrue / Comfilcon A | Papillary Conjunctivitis | Baseline | 1.07 units on a scale | Standard Deviation 0.24 |
| Biotrue / Comfilcon A | Papillary Conjunctivitis | 2 weeks | 1.06 units on a scale | Standard Deviation 0.2 |
| Biotrue / Comfilcon A | Papillary Conjunctivitis | 1 week | 1.04 units on a scale | Standard Deviation 0.23 |
Primary
Vision
Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 4 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.
Time frame: 4 weeks
Population: The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Synergi / Comfilcon A | Vision | Night vision | 92.1 units on a scale | Standard Deviation 8.6 |
| Synergi / Comfilcon A | Vision | Distance vision | 92.5 units on a scale | Standard Deviation 8.8 |
| Synergi / Comfilcon A | Vision | Variable vision | 92.6 units on a scale | Standard Deviation 12.5 |
| Biotrue / Comfilcon A | Vision | Night vision | 91.9 units on a scale | Standard Deviation 11.5 |
| Biotrue / Comfilcon A | Vision | Variable vision | 94.1 units on a scale | Standard Deviation 9.5 |
| Biotrue / Comfilcon A | Vision | Distance vision | 92.6 units on a scale | Standard Deviation 10.4 |
Primary
Vision
Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 2 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.
Time frame: 2 weeks
Population: The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Synergi / Comfilcon A | Vision | Distance vision | 92.8 units on a scale | Standard Deviation 8.7 |
| Synergi / Comfilcon A | Vision | Variable vision | 94.3 units on a scale | Standard Deviation 9.6 |
| Synergi / Comfilcon A | Vision | Night vision | 93.2 units on a scale | Standard Deviation 8.1 |
| Biotrue / Comfilcon A | Vision | Distance vision | 91.1 units on a scale | Standard Deviation 13 |
| Biotrue / Comfilcon A | Vision | Variable vision | 90.5 units on a scale | Standard Deviation 12.3 |
| Biotrue / Comfilcon A | Vision | Night vision | 90.8 units on a scale | Standard Deviation 12.7 |
Primary
Vision
Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.
Time frame: 1 week
Population: The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Synergi / Comfilcon A | Vision | Distance vision | 91.1 units on a scale | Standard Deviation 12.7 |
| Synergi / Comfilcon A | Vision | Variable vision | 92.1 units on a scale | Standard Deviation 12.7 |
| Synergi / Comfilcon A | Vision | Night vision | 90.4 units on a scale | Standard Deviation 12.3 |
| Biotrue / Comfilcon A | Vision | Distance vision | 92.1 units on a scale | Standard Deviation 10.4 |
| Biotrue / Comfilcon A | Vision | Variable vision | 92.1 units on a scale | Standard Deviation 12.4 |
| Biotrue / Comfilcon A | Vision | Night vision | 91.6 units on a scale | Standard Deviation 11.2 |