Trial Outcomes & Findings for BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens (NCT NCT02196766)
NCT ID: NCT02196766
Last Updated: 2020-07-29
Results Overview
Corneal staining for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
1 week
Results posted on
2020-07-29
Participant Flow
Participant milestones
| Measure |
Bioclean First Care EX Combo, Then Aosept Clearcare Combo
Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
|
Aosept Clearcare Combo First,Then Bioclean First Care EX Combo
Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
|
|---|---|---|
|
First Intervention (7 Days)
STARTED
|
15
|
15
|
|
First Intervention (7 Days)
COMPLETED
|
15
|
15
|
|
First Intervention (7 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (7 Days)
STARTED
|
15
|
15
|
|
Second Intervention (7 Days)
COMPLETED
|
15
|
15
|
|
Second Intervention (7 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens
Baseline characteristics by cohort
| Measure |
Bioclean First Care EX / Aosept Clearcare / Comfil
n=30 Participants
Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
|
|---|---|
|
Age, Continuous
|
31 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 weekCorneal staining for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Outcome measures
| Measure |
Bioclean First Care EX / Comfilcon A
n=60 Eyes
Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
|
Aosept Clearcare / Comfilcon A
n=60 Eyes
Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
|
|---|---|---|
|
Ocular Health - Corneal Staining
Normal
|
38 Eyes
|
35 Eyes
|
|
Ocular Health - Corneal Staining
Trace
|
18 Eyes
|
20 Eyes
|
|
Ocular Health - Corneal Staining
Mild
|
4 Eyes
|
5 Eyes
|
|
Ocular Health - Corneal Staining
Moderate
|
0 Eyes
|
0 Eyes
|
|
Ocular Health - Corneal Staining
Severe
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: 1 weekConjunctival redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Outcome measures
| Measure |
Bioclean First Care EX / Comfilcon A
n=60 Eyes
Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
|
Aosept Clearcare / Comfilcon A
n=60 Eyes
Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
|
|---|---|---|
|
Ocular Health - Conjunctival Redness
Normal
|
40 Eyes
|
40 Eyes
|
|
Ocular Health - Conjunctival Redness
Trace
|
20 Eyes
|
20 Eyes
|
|
Ocular Health - Conjunctival Redness
Mild
|
0 Eyes
|
0 Eyes
|
|
Ocular Health - Conjunctival Redness
Moderate
|
0 Eyes
|
0 Eyes
|
|
Ocular Health - Conjunctival Redness
Severe
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: 1 weekLimbal redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Outcome measures
| Measure |
Bioclean First Care EX / Comfilcon A
n=60 Eyes
Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
|
Aosept Clearcare / Comfilcon A
n=60 Eyes
Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
|
|---|---|---|
|
Ocular Health - Limbal Redness
Normal
|
49 Eyes
|
47 Eyes
|
|
Ocular Health - Limbal Redness
Trace
|
11 Eyes
|
12 Eyes
|
|
Ocular Health - Limbal Redness
Mild
|
0 Eyes
|
1 Eyes
|
|
Ocular Health - Limbal Redness
Moderate
|
0 Eyes
|
0 Eyes
|
|
Ocular Health - Limbal Redness
Severe
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: 1 weekPapillary conjunctivitis for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Outcome measures
| Measure |
Bioclean First Care EX / Comfilcon A
n=60 Eyes
Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
|
Aosept Clearcare / Comfilcon A
n=60 Eyes
Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
|
|---|---|---|
|
Ocular Health - Papillary Conjunctivitis
Normal
|
52 Eyes
|
51 Eyes
|
|
Ocular Health - Papillary Conjunctivitis
Trace
|
7 Eyes
|
8 Eyes
|
|
Ocular Health - Papillary Conjunctivitis
Mild
|
1 Eyes
|
1 Eyes
|
|
Ocular Health - Papillary Conjunctivitis
Moderate
|
0 Eyes
|
0 Eyes
|
|
Ocular Health - Papillary Conjunctivitis
Severe
|
0 Eyes
|
0 Eyes
|
SECONDARY outcome
Timeframe: BaselineSubjective rating of stinging sensation for the combinations is assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).
Outcome measures
| Measure |
Bioclean First Care EX / Comfilcon A
n=30 Participants
Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
|
Aosept Clearcare / Comfilcon A
n=30 Participants
Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
|
|---|---|---|
|
Stinging Sensation Right After Insertion (Subjective Rating)
|
9.5 units on a scale
Standard Deviation 1.1
|
9.4 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: BaselineSubjective rating of burning sensation right after insertion for each combination assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).
Outcome measures
| Measure |
Bioclean First Care EX / Comfilcon A
n=30 Participants
Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
|
Aosept Clearcare / Comfilcon A
n=30 Participants
Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
|
|---|---|---|
|
Burning Sensation Right After Insertion (Subjective Rating)
|
9.5 units on a scale
Standard Deviation 1.1
|
9.4 units on a scale
Standard Deviation 1.2
|
Adverse Events
Bioclean First Care EX / Comfilcon A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aosept Clearcare / Comfilcon A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Taku Muraoka, OD, Director Professional Services Organization
Coopervision Japan
Phone: 81-3-5449-6619
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators are NOT employed by the organization sponsoring the study. There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.
- Publication restrictions are in place
Restriction type: OTHER