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
This study is designed to evaluate ocufilcon D lens compared to ocufilcon B lens in a 1-week crossover, daily wear regimen.
This study is designed to evaluate 2 daily disposable contact lenses that are both currently cleared for the USA market. Study of the ocufilcon D lens compared to the ocufilcon B lens in a 1-week crossover, daily wear regimen. The primary objective is the comparison of fitting characteristics. The secondary objective is the comparison of comfort, end of day comfort and dryness measures.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ocufilcon D | Experimental | Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week. |
|
| ocufilcon B | Active Comparator | Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ocufilcon D | Device | Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lens Fit - Decentration After Insertion | The ophthalmologist's objective assessment of lens fit measurement of decentration after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (mm, horizontal and vertical). | Baseline and 7 days from baseline visit |
| Lens Fit - Decentration at One Week | The ophthalmologist's objective assessment of lens fit measurement of decentration of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). Each pair worn for one week daily disposable wear basis (at least 8 hours per day, 7 days per week). Lenses worn minimum 2 hours prior to visit. (mm, horizontal and vertical). | 7 days and 14 days from baseline visit |
| Lens Fit - Tightness After Insertion | The ophthalmologist's rating of lens fit measurement of push-up tightness after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (0-100%, 5% steps, 0%=excessively loose, 50%=optimum, 100%=excessively tight ). | Baseline and 7 days from baseline visit |
| Lens Fit - Tightness at One Week | The ophthalmologist's rating of lens fit measurement of push-up tightness of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). Each pair worn for one week daily disposable wear basis (at least 8 hours per day, 7 days per week). Lenses worn minimum 2 hours prior to visit. (0-100%, 5% steps, 0%=excessively loose, 50%=optimum, 100%=excessively tight ). | 7 days and 14 days from baseline visit |
| Lens Fit - Post-Blink Lens Movement After Insertion | The ophthalmologist's objective assessment of lens fit measurement of post-blink lens movement after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (mm). |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Preference - Comfort After Insertion | Participant's subjective rating for overall preference of lens comfort immediately after insertion for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thao N Yeh, OD | U.C. Berkeley, School of Optometry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center, U.C. Berkeley, School of Optometry | Berkeley | California | 94720- | United States |
Fifty subjects started. Forty-nine subjects completed the study. One subject was disqualified after one week of wear of the control lens (ocufilcon B) during the 1st week of the study due to unresolved corneal staining.
A total of 71 subjects were recruited for the study, with 21 subjects being disqualified at the initial screening for a total of 50 subjects started.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ocufilcon D Then Ocufilcon B | Participants were randomized to wear ocufilcon D lenses for 1 week and then crossed over to the ocufilcon B lens pair for 1 week. |
| FG001 | Ocufulcon B Then Ocufilcon D | Participants were randomized to wear ocufilcon B lenses for 1 week and then crossed over to the ocufilcon D lens pair for 1 week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
1 subject being disqualified after 1 week of wear
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ocufilcon D Then Ocufilcon B | Participants were randomized to wear ocufilcon D lenses for 1 week and then crossed over to the ocufilcon B lens pair for 1 week. |
| BG001 | Ocufilcon B Then Ocufilcon D |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Lens Fit - Decentration After Insertion | The ophthalmologist's objective assessment of lens fit measurement of decentration after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (mm, horizontal and vertical). | Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2 | Posted | Mean | Standard Deviation | mm | Baseline and 7 days from baseline visit |
|
Not provided
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 | Ocufilcon D | Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thao N Yeh, O.D. | Clinical Research Center, University of California, Berkeley, School of Optometry | (510) 642-9649 | thaoyeh@berkeley.edu |
Not provided
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| ocufilcon B | Device | Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week. |
|
|
| Baseline and 7 days from baseline visit |
| Lens Fit - Post-Blink Lens Movement Prior to Removal | The ophthalmologist's objective assessment of lens fit measurement of post-blink lens movement prior to removal of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). (mm). | 7 days and 14 days from baseline visit |
| 14 days from baseline visit |
| Overall Preference - Comfort Before Removal | Participant's subjective rating for overall preference of lens comfort immediately before removal for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses. | 14 days from baseline visit |
| Overall Preference - Dryness After Insertion | Participant's subjective rating for overall preference of lens dryness immediately after insertion for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses. | 14 days from baseline visit |
| Overall Preference - Dryness Before Removal | Participant's subjective rating for overall preference of lens dryness immediately before removal for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses. | 14 days from baseline visit |
| Overall Preference - Handling, Inserting | Participant's subjective rating for overall preference of lens ease of handling at inserting for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses. | 14 days from baseline visit |
| Overall Preference - Handling, Removing | Participant's subjective rating for overall preference of lens ease of handling at removing for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses. | 14 days from baseline visit |
| Overall Lens Pair Preference | Participant's subjective rating for overall preference for lens pair #1 or Pair #2 based on comfort, vision and handling. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses. | 14 days from baseline visit |
Participants were randomized to wear ocufilcon B lenses for 1 week and then crossed over to the ocufilcon D lens pair for 1 week.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
|
|
| Primary | Lens Fit - Decentration at One Week | The ophthalmologist's objective assessment of lens fit measurement of decentration of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). Each pair worn for one week daily disposable wear basis (at least 8 hours per day, 7 days per week). Lenses worn minimum 2 hours prior to visit. (mm, horizontal and vertical). | Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2 | Posted | Mean | Standard Deviation | mm | 7 days and 14 days from baseline visit |
|
|
|
| Primary | Lens Fit - Tightness After Insertion | The ophthalmologist's rating of lens fit measurement of push-up tightness after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (0-100%, 5% steps, 0%=excessively loose, 50%=optimum, 100%=excessively tight ). | Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2 | Posted | Mean | Standard Deviation | percentage of tightness | Baseline and 7 days from baseline visit |
|
|
|
| Primary | Lens Fit - Tightness at One Week | The ophthalmologist's rating of lens fit measurement of push-up tightness of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). Each pair worn for one week daily disposable wear basis (at least 8 hours per day, 7 days per week). Lenses worn minimum 2 hours prior to visit. (0-100%, 5% steps, 0%=excessively loose, 50%=optimum, 100%=excessively tight ). | Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2 | Posted | Mean | Standard Deviation | percentage of tightness | 7 days and 14 days from baseline visit |
|
|
|
| Secondary | Overall Preference - Comfort After Insertion | Participant's subjective rating for overall preference of lens comfort immediately after insertion for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses. | Posted | Number | percentage of participants | 14 days from baseline visit |
|
|
|
| Secondary | Overall Preference - Comfort Before Removal | Participant's subjective rating for overall preference of lens comfort immediately before removal for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses. | Posted | Number | percentage of participants | 14 days from baseline visit |
|
|
|
| Secondary | Overall Preference - Dryness After Insertion | Participant's subjective rating for overall preference of lens dryness immediately after insertion for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses. | Posted | Number | percentage of participants | 14 days from baseline visit |
|
|
|
| Secondary | Overall Preference - Dryness Before Removal | Participant's subjective rating for overall preference of lens dryness immediately before removal for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses. | Posted | Number | percentage of participants | 14 days from baseline visit |
|
|
|
| Secondary | Overall Preference - Handling, Inserting | Participant's subjective rating for overall preference of lens ease of handling at inserting for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses. | Posted | Number | percentage of participants | 14 days from baseline visit |
|
|
|
| Secondary | Overall Preference - Handling, Removing | Participant's subjective rating for overall preference of lens ease of handling at removing for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses. | Posted | Number | percentage of participants | 14 days from baseline visit |
|
|
|
| Secondary | Overall Lens Pair Preference | Participant's subjective rating for overall preference for lens pair #1 or Pair #2 based on comfort, vision and handling. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses. | Posted | Number | percentage of participants | 14 days from baseline visit |
|
|
|
| Primary | Lens Fit - Post-Blink Lens Movement After Insertion | The ophthalmologist's objective assessment of lens fit measurement of post-blink lens movement after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (mm). | Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2 | Posted | Mean | Standard Deviation | mm | Baseline and 7 days from baseline visit |
|
|
|
| Primary | Lens Fit - Post-Blink Lens Movement Prior to Removal | The ophthalmologist's objective assessment of lens fit measurement of post-blink lens movement prior to removal of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). (mm). | Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2 | Posted | Mean | Standard Deviation | mm | 7 days and 14 days from baseline visit |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Ocufilcon B | Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week. | 0 | 50 | 0 | 50 |
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. This restriction will apply for a period of five years from completion of the study.
| Title | Measurements |
|---|---|
|
| Slightly Prefer Control Lenses |
|
| Strongly Prefer Control Lenses |
|
| Title | Measurements |
|---|---|
|
| Slightly Prefer Control Lenses |
|
| Strongly Prefer Control Lenses |
|
| Title | Measurements |
|---|---|
|
| Slightly Prefer Control Lenses |
|
| Strongly Prefer Control Lenses |
|
| Title | Measurements |
|---|---|
|
| Slightly Prefer Control Lenses |
|
| Strongly Prefer Control Lenses |
|
| Title | Measurements |
|---|---|
|
| Slightly Prefer Control Lenses |
|
| Strongly Prefer Control Lenses |
|
| Title | Measurements |
|---|---|
|
| Slightly Prefer Control Lenses |
|
| Strongly Prefer Control Lenses |
|
| Title | Measurements |
|---|---|
|
| Slightly Prefer Control Lenses |
|
| Strongly Prefer Control Lenses |
|