Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To determine if patients are unreactive to the lens care solution / Biofinity combination.
To determine if patients are unreactive to the lens care solution / Biofinity combination in this cross-over study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bioclean First Care EX combo, then Aosept Clearcare combo | Active Comparator | Subjects dispensed Bioclean First Care EX / comfilcon A combination then crossed over to the Aosept Clearcare / comfilcon A combination. |
|
| Aosept Clearcare combo, then Bioclean First Care EX combo | Active Comparator | Subjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the Bioclean First Care EX / comfilcon A combination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bioclean First Care EX / comfilcon A | Other | Subjects dispensed Bioclean First Care EX / comfilcon A combination then crossed over to the alternate combination. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Health - Corneal Staining | 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). | 1 week |
| Ocular Health - Conjunctival Redness | Conjunctival 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). | 1 week |
| Ocular Health - Limbal Redness | Limbal 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). | 1 week |
| Ocular Health - Papillary Conjunctivitis | Papillary 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). | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Stinging Sensation Right After Insertion (Subjective Rating) | Subjective rating of stinging sensation for the combinations is assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all). | Baseline |
| Burning Sensation Right After Insertion (Subjective Rating) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Taku Muraoka, OD | Director Professional Services, CVI Japan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kokama Eye Clinic | Joyo-shi | Kyoto | 610-0121 | Japan | ||
| Higashihara Clinic |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (7 Days) |
| |||||||||||||
| Second Intervention (7 Days) |
|
Overall participants group prior to randomization of study lens pairs and solution.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bioclean First Care EX / Aosept Clearcare / Comfil | Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ocular Health - Corneal Staining | 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). | Posted | Number | Eyes | 1 week | Eyes | Eyes |
|
From dispense up to two weeks for study lenses with both study lens care solutions
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Taku Muraoka, OD, Director Professional Services Organization | Coopervision Japan | 81-3-5449-6619 | taku.muraoka@jp.coopervision.com |
Not provided
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C540498 | comfilcon A |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Aosept Clearcare / comfilcon A | Other | Subjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the alternate combination. |
|
Subjective 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). |
| Baseline |
| Kameoka |
| Kyoto |
| 621-0861 |
| Japan |
| Dougenzaka Ioti Eye Clinic | Shibuya-ku | Tokyo-to | 150-0043 | Japan |
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Stinging Sensation Right After Insertion (Subjective Rating) | Subjective rating of stinging sensation for the combinations is assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all). | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | Burning Sensation Right After Insertion (Subjective Rating) | Subjective 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Primary | Ocular Health - Conjunctival Redness | Conjunctival 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). | Posted | Number | Eyes | 1 week | Eyes | Eyes |
|
|
|
| Primary | Ocular Health - Limbal Redness | Limbal 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). | Posted | Number | Eyes | 1 week | Eyes | Eyes |
|
|
|
| Primary | Ocular Health - Papillary Conjunctivitis | Papillary 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). | Posted | Number | Eyes | 1 week | Eyes | Eyes |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | 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. 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. | 0 | 30 | 0 | 30 |
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.
| Mild |
|
| Moderate |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Severe |
|