Trial Outcomes & Findings for The Clinical Performance of the Biofinity Contact Lens (Comfilcon A) With Two Lens Care Systems (NCT NCT02510820)
NCT ID: NCT02510820
Last Updated: 2017-02-01
Results Overview
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.
COMPLETED
NA
51 participants
Baseline, 1 week, 2 weeks, 4 weeks
2017-02-01
Participant Flow
Three subjects were not dispensed the combination of multipurpose solutions.
Participant milestones
| Measure |
Synergi/Comfilcon A Combo, Then Biotrue/Comfilcon A Combo
Participants were randomized to wear Synergi/comfilcon A combination for one month, then cross over to the alternative Biotrue/comfilcon A combination.
|
Biotrue/Comfilcon A Combo, Then Synergi/Comfilcon A Combo
Participants were randomized to wear Biotrue/comfilcon A combination for one month, then cross over to the alternative Synergi/comfilcon A combination.
|
|---|---|---|
|
First Intervention (4 Weeks)
STARTED
|
21
|
27
|
|
First Intervention (4 Weeks)
COMPLETED
|
21
|
26
|
|
First Intervention (4 Weeks)
NOT COMPLETED
|
0
|
1
|
|
Washout (1 Week)
STARTED
|
21
|
26
|
|
Washout (1 Week)
COMPLETED
|
21
|
26
|
|
Washout (1 Week)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (4 Weeks)
STARTED
|
21
|
26
|
|
Second Intervention (4 Weeks)
COMPLETED
|
20
|
26
|
|
Second Intervention (4 Weeks)
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Synergi/Comfilcon A Combo, Then Biotrue/Comfilcon A Combo
Participants were randomized to wear Synergi/comfilcon A combination for one month, then cross over to the alternative Biotrue/comfilcon A combination.
|
Biotrue/Comfilcon A Combo, Then Synergi/Comfilcon A Combo
Participants were randomized to wear Biotrue/comfilcon A combination for one month, then cross over to the alternative Synergi/comfilcon A combination.
|
|---|---|---|
|
First Intervention (4 Weeks)
Withdrawal by Subject
|
0
|
1
|
|
Second Intervention (4 Weeks)
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
The Clinical Performance of the Biofinity Contact Lens (Comfilcon A) With Two Lens Care Systems
Baseline characteristics by cohort
| Measure |
Overall Baseline Characteristics
n=51 Participants
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.
|
|---|---|
|
Age, Continuous
|
33.3 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
51 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 week, 2 weeks, 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Synergi / Comfilcon A
n=47 Participants
Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution
|
Biotrue / Comfilcon A
n=48 Participants
Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution
|
|---|---|---|
|
Conjunctival Hyperaemia
Baseline
|
0.84 units on a scale
Standard Deviation 0.24
|
0.87 units on a scale
Standard Deviation 0.21
|
|
Conjunctival Hyperaemia
1 week
|
0.87 units on a scale
Standard Deviation 0.21
|
0.87 units on a scale
Standard Deviation 0.22
|
|
Conjunctival Hyperaemia
2 weeks
|
0.88 units on a scale
Standard Deviation 0.24
|
0.83 units on a scale
Standard Deviation 0.21
|
|
Conjunctival Hyperaemia
4 weeks
|
0.90 units on a scale
Standard Deviation 0.21
|
0.82 units on a scale
Standard Deviation 0.17
|
PRIMARY outcome
Timeframe: Baseline, 1 week, 2 weeks, 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Synergi / Comfilcon A
n=47 Participants
Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution
|
Biotrue / Comfilcon A
n=48 Participants
Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution
|
|---|---|---|
|
Limbal Hyperaemia
Baseline
|
0.73 units on a scale
Standard Deviation 0.26
|
0.77 units on a scale
Standard Deviation 0.22
|
|
Limbal Hyperaemia
1 week
|
0.80 units on a scale
Standard Deviation 0.23
|
0.75 units on a scale
Standard Deviation 0.24
|
|
Limbal Hyperaemia
2 weeks
|
0.73 units on a scale
Standard Deviation 0.25
|
0.70 units on a scale
Standard Deviation 0.26
|
|
Limbal Hyperaemia
4 weeks
|
0.78 units on a scale
Standard Deviation 0.22
|
0.72 units on a scale
Standard Deviation 0.21
|
PRIMARY outcome
Timeframe: Baseline, 1 week, 2 weeks, 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Synergi / Comfilcon A
n=47 Participants
Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution
|
Biotrue / Comfilcon A
n=48 Participants
Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution
|
|---|---|---|
|
Corneal Staining
Baseline
|
0.30 units on a scale
Standard Deviation 0.48
|
0.17 units on a scale
Standard Deviation 0.34
|
|
Corneal Staining
1 week
|
0.34 units on a scale
Standard Deviation 0.40
|
0.67 units on a scale
Standard Deviation 0.47
|
|
Corneal Staining
2 weeks
|
0.38 units on a scale
Standard Deviation 0.46
|
0.59 units on a scale
Standard Deviation 0.54
|
|
Corneal Staining
4 weeks
|
0.31 units on a scale
Standard Deviation 0.42
|
0.62 units on a scale
Standard Deviation 0.51
|
PRIMARY outcome
Timeframe: Baseline, 1 week, 2 weeks, 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Synergi / Comfilcon A
n=47 Participants
Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution
|
Biotrue / Comfilcon A
n=48 Participants
Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution
|
|---|---|---|
|
Papillary Conjunctivitis
1 week
|
1.05 units on a scale
Standard Deviation 0.24
|
1.04 units on a scale
Standard Deviation 0.23
|
|
Papillary Conjunctivitis
2 weeks
|
1.05 units on a scale
Standard Deviation 0.26
|
1.06 units on a scale
Standard Deviation 0.20
|
|
Papillary Conjunctivitis
Baseline
|
1.04 units on a scale
Standard Deviation 0.22
|
1.07 units on a scale
Standard Deviation 0.24
|
|
Papillary Conjunctivitis
4 weeks
|
1.09 units on a scale
Standard Deviation 0.24
|
1.06 units on a scale
Standard Deviation 0.24
|
PRIMARY outcome
Timeframe: 1 weekSubjective 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.
Outcome measures
| Measure |
Synergi / Comfilcon A
n=46 Participants
Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution
|
Biotrue / Comfilcon A
n=47 Participants
Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution
|
|---|---|---|
|
Comfort
Comfort after insertion
|
88.7 units on a scale
Standard Deviation 11.4
|
83.4 units on a scale
Standard Deviation 17.9
|
|
Comfort
Comfort before removal
|
76.8 units on a scale
Standard Deviation 17.2
|
72.4 units on a scale
Standard Deviation 22.4
|
|
Comfort
Overall comfort
|
85.6 units on a scale
Standard Deviation 11.8
|
82.8 units on a scale
Standard Deviation 13.9
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Synergi / Comfilcon A
n=46 Participants
Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution
|
Biotrue / Comfilcon A
n=45 Participants
Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution
|
|---|---|---|
|
Comfort
Comfort after insertion
|
87.0 units on a scale
Standard Deviation 12.6
|
85.6 units on a scale
Standard Deviation 14.8
|
|
Comfort
Comfort before removal
|
78.1 units on a scale
Standard Deviation 19.4
|
73.9 units on a scale
Standard Deviation 20.9
|
|
Comfort
Overall comfort
|
84.7 units on a scale
Standard Deviation 14.9
|
83.2 units on a scale
Standard Deviation 14.8
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Synergi / Comfilcon A
n=45 Participants
Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution
|
Biotrue / Comfilcon A
n=45 Participants
Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution
|
|---|---|---|
|
Comfort
Comfort after insertion
|
88.3 units on a scale
Standard Deviation 11.0
|
87.3 units on a scale
Standard Deviation 15.5
|
|
Comfort
Comfort before removal
|
76.1 units on a scale
Standard Deviation 21.2
|
75.0 units on a scale
Standard Deviation 20.0
|
|
Comfort
Overall comfort
|
85.3 units on a scale
Standard Deviation 14.3
|
84.5 units on a scale
Standard Deviation 14.0
|
PRIMARY outcome
Timeframe: 1 weekPopulation: 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.
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.
Outcome measures
| Measure |
Synergi / Comfilcon A
n=46 Participants
Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution
|
Biotrue / Comfilcon A
n=47 Participants
Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution
|
|---|---|---|
|
Vision
Distance vision
|
91.1 units on a scale
Standard Deviation 12.7
|
92.1 units on a scale
Standard Deviation 10.4
|
|
Vision
Variable vision
|
92.1 units on a scale
Standard Deviation 12.7
|
92.1 units on a scale
Standard Deviation 12.4
|
|
Vision
Night vision
|
90.4 units on a scale
Standard Deviation 12.3
|
91.6 units on a scale
Standard Deviation 11.2
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Synergi / Comfilcon A
n=46 Participants
Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution
|
Biotrue / Comfilcon A
n=45 Participants
Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution
|
|---|---|---|
|
Vision
Distance vision
|
92.8 units on a scale
Standard Deviation 8.7
|
91.1 units on a scale
Standard Deviation 13.0
|
|
Vision
Variable vision
|
94.3 units on a scale
Standard Deviation 9.6
|
90.5 units on a scale
Standard Deviation 12.3
|
|
Vision
Night vision
|
93.2 units on a scale
Standard Deviation 8.1
|
90.8 units on a scale
Standard Deviation 12.7
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Synergi / Comfilcon A
n=45 Participants
Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution
|
Biotrue / Comfilcon A
n=45 Participants
Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution
|
|---|---|---|
|
Vision
Distance vision
|
92.5 units on a scale
Standard Deviation 8.8
|
92.6 units on a scale
Standard Deviation 10.4
|
|
Vision
Variable vision
|
92.6 units on a scale
Standard Deviation 12.5
|
94.1 units on a scale
Standard Deviation 9.5
|
|
Vision
Night vision
|
92.1 units on a scale
Standard Deviation 8.6
|
91.9 units on a scale
Standard Deviation 11.5
|
PRIMARY outcome
Timeframe: 1 week, 2 weeks, 4 weeksSubjective 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.
Outcome measures
| Measure |
Synergi / Comfilcon A
n=47 Participants
Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution
|
Biotrue / Comfilcon A
n=48 Participants
Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution
|
|---|---|---|
|
Dryness
4 weeks
|
79.9 units on a scale
Standard Deviation 20.9
|
81.7 units on a scale
Standard Deviation 20.3
|
|
Dryness
2 weeks
|
79.5 units on a scale
Standard Deviation 20.5
|
80.2 units on a scale
Standard Deviation 19.8
|
|
Dryness
1 week
|
82.8 units on a scale
Standard Deviation 16.3
|
79.3 units on a scale
Standard Deviation 20.0
|
PRIMARY outcome
Timeframe: 1 week, 2 weeks, 4 weeksSubjective 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.
Outcome measures
| Measure |
Synergi / Comfilcon A
n=47 Participants
Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution
|
Biotrue / Comfilcon A
n=48 Participants
Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution
|
|---|---|---|
|
Burning/Stinging
1 week
|
94.3 units on a scale
Standard Deviation 13.0
|
95.7 units on a scale
Standard Deviation 9.4
|
|
Burning/Stinging
2 weeks
|
96.0 units on a scale
Standard Deviation 8.4
|
96.8 units on a scale
Standard Deviation 8.7
|
|
Burning/Stinging
4 weeks
|
94.6 units on a scale
Standard Deviation 10.9
|
96.5 units on a scale
Standard Deviation 9.3
|
PRIMARY outcome
Timeframe: 1 week, 2 weeks, 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Synergi / Comfilcon A
n=46 Participants
Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution
|
Biotrue / Comfilcon A
n=47 Participants
Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution
|
|---|---|---|
|
Ocular Redness
1 week
|
96.0 units on a scale
Standard Deviation 9.9
|
96.8 units on a scale
Standard Deviation 6.4
|
|
Ocular Redness
2 weeks
|
95.4 units on a scale
Standard Deviation 9.6
|
96.5 units on a scale
Standard Deviation 8.2
|
|
Ocular Redness
4 weeks
|
95.5 units on a scale
Standard Deviation 8.1
|
95.7 units on a scale
Standard Deviation 9.9
|
PRIMARY outcome
Timeframe: 1 week, 2 weeks, 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Synergi / Comfilcon A
n=46 Participants
Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution
|
Biotrue / Comfilcon A
n=47 Participants
Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution
|
|---|---|---|
|
Ease of Lens Insertion
1 week
|
90.9 units on a scale
Standard Deviation 11.8
|
93.2 units on a scale
Standard Deviation 8.5
|
|
Ease of Lens Insertion
2 weeks
|
90.8 units on a scale
Standard Deviation 8.8
|
93.4 units on a scale
Standard Deviation 8.9
|
|
Ease of Lens Insertion
4 weeks
|
91.8 units on a scale
Standard Deviation 8.7
|
93.5 units on a scale
Standard Deviation 8.8
|
PRIMARY outcome
Timeframe: 1 week, 2 weeks, 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Synergi / Comfilcon A
n=46 Participants
Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution
|
Biotrue / Comfilcon A
n=47 Participants
Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution
|
|---|---|---|
|
Ease of Lens Removal
1 week
|
91.1 units on a scale
Standard Deviation 14.0
|
92.2 units on a scale
Standard Deviation 11.8
|
|
Ease of Lens Removal
2 weeks
|
90.7 units on a scale
Standard Deviation 11.9
|
94.0 units on a scale
Standard Deviation 10.5
|
|
Ease of Lens Removal
4 weeks
|
91.3 units on a scale
Standard Deviation 11.2
|
94.4 units on a scale
Standard Deviation 8.2
|
PRIMARY outcome
Timeframe: 1 week, 2 weeks, 4 weeksSubjective 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
Outcome measures
| Measure |
Synergi / Comfilcon A
n=47 Participants
Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution
|
Biotrue / Comfilcon A
n=48 Participants
Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution
|
|---|---|---|
|
Ease of Use of Solution
1 week
|
87.7 units on a scale
Standard Deviation 17.3
|
92.2 units on a scale
Standard Deviation 11.4
|
|
Ease of Use of Solution
2 weeks
|
88.2 units on a scale
Standard Deviation 17.5
|
93.6 units on a scale
Standard Deviation 11.0
|
|
Ease of Use of Solution
4 weeks
|
88.7 units on a scale
Standard Deviation 15.3
|
92.7 units on a scale
Standard Deviation 12.6
|
PRIMARY outcome
Timeframe: 1 week, 2 weeks, 4 weeksPopulation: Data not collected as follows: 2 weeks (1 participant) and 4 weeks (1 participant - Synergi, 1 participant - Biotrue).
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.
Outcome measures
| Measure |
Synergi / Comfilcon A
n=46 Participants
Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Synergi: Multipurpose solution
|
Biotrue / Comfilcon A
n=47 Participants
Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.
comfilcon A: soft contact lens
Biotrue: Multipurpose solution
|
|---|---|---|
|
Overall Score
4 weeks
|
88.8 units on a scale
Standard Deviation 15.4
|
91.7 units on a scale
Standard Deviation 12.7
|
|
Overall Score
1 week
|
90.3 units on a scale
Standard Deviation 12.6
|
90.6 units on a scale
Standard Deviation 11.7
|
|
Overall Score
2 weeks
|
88.3 units on a scale
Standard Deviation 15.0
|
90.7 units on a scale
Standard Deviation 12.5
|
Adverse Events
Biotrue/Comfilcon A Combo, Then Synergi/Comfilcon A Combo
Synergi/Comfilcon A Combo, Then Biotrue/Comfilcon A Combo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sr. Manager Global Medical Scientific Affairs
CooperVision
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER