An interventional study of ocufilcon D and ocufilcon B in Myopia, sponsored by CooperVision International Limited (CVIL). Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2014-08-19.
Sponsored by CooperVision International Limited (CVIL) · Not applicable and Interventional
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.
984 studies on the registry are indexed under Myopia; 209 are open to participants now.
This study's enrollment of 71 is below the median of 80 across 782 interventional studies indexed under Myopia.
Browse Myopia studies →CooperVision International Limited (CVIL) is the lead sponsor of 138 studies on the registry; 9 are open to participants now.
Of its 72 completed or terminated interventional studies of FDA-regulated products, 67 (93%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
Device: ocufilcon B
Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
Device: ocufilcon D
Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
Also known as: oculfilcon D (Daily wear soft contact lens)
Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
Also known as: oculfilcon B (Daily wear soft contact lens)
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).
Time frame: 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).
Time frame: 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 ).
Time frame: 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 ).
Time frame: 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).
Time frame: 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).
Time frame: 7 days and 14 days from baseline visit
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 14 days from baseline visit
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.
| Milestone | Ocufilcon D Then Ocufilcon B | Ocufulcon B Then Ocufilcon D |
|---|---|---|
| Started | 25 | 25 |
| Completed | 25 | 24 |
| Not completed | 0 | 1 |
| Withdrew: Unresolve corneal staining | 0 | 1 |
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).
| mm | Ocufilcon D Then Ocufilcon B | Ocufilcon B Then Ocufilcon D |
|---|---|---|
| Horizontal | 0.12 ± 0.29 | 0.07 ± 0.30 |
| Vertical | -0.11 ± 0.47 | -0.15 ± 0.48 |
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).
| mm | Ocufilcon D Then Ocufilcon B | Ocufilcon B Then Ocufilcon D |
|---|---|---|
| Horizontal | 0.14 ± 0.36 | 0.09 ± 0.37 |
| Vertical | -0.08 ± 0.39 | -0.18 ± 0.51 |
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 ).
| percentage of tightness | Ocufilcon D Then Ocufilcon B | Ocufilcon B Then Ocufilcon D |
|---|---|---|
| Lens Fit - Tightness After Insertion | 50.0 ± 14.1 | 52.4 ± 15.7 |
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 ).
| percentage of tightness | Ocufilcon D Then Ocufilcon B | Ocufilcon B Then Ocufilcon D |
|---|---|---|
| Lens Fit - Tightness at One Week | 42.4 ± 12.9 | 46 ± 13.7 |
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.
| percentage of participants | Overall Study Group |
|---|---|
| Strongly Prefer Test Lenses | 43 |
| Slightly Prefer Test Lenses | 21 |
| No Preference | 18 |
| Slightly Prefer Control Lenses | 16 |
| Strongly Prefer Control Lenses | 2 |
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.
| percentage of participants | Overall Study Group |
|---|---|
| Strongly Prefer Test Lenses | 29 |
| Slightly Prefer Test Lenses | 29 |
| No Preference | 18 |
| Slightly Prefer Control Lenses | 20 |
| Strongly Prefer Control Lenses | 4 |
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.
| percentage of participants | Overall Study Group |
|---|---|
| Strongly Prefer Test Lenses | 23 |
| Slightly Prefer Test Lenses | 12 |
| No Preference | 55 |
| Slightly Prefer Control Lenses | 10 |
| Strongly Prefer Control Lenses | 0 |
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.
| percentage of participants | Overall Study Group |
|---|---|
| Strongly Prefer Test Lenses | 33 |
| Slightly Prefer Test Lenses | 22 |
| No Preference | 25 |
| Slightly Prefer Control Lenses | 18 |
| Strongly Prefer Control Lenses | 2 |
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.
| percentage of participants | Overall Study Group |
|---|---|
| Strongly Prefer Test Lenses | 18 |
| Slightly Prefer Test Lenses | 23 |
| No Preference | 47 |
| Slightly Prefer Control Lenses | 8 |
| Strongly Prefer Control Lenses | 4 |
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.
| percentage of participants | Overall Study Group |
|---|---|
| Strongly Prefer Test Lenses | 8 |
| Slightly Prefer Test Lenses | 16 |
| No Preference | 74 |
| Slightly Prefer Control Lenses | 2 |
| Strongly Prefer Control Lenses | 0 |
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.
| percentage of participants | Overall Study Group |
|---|---|
| Strongly Prefer Test Lenses | 43 |
| Slightly Prefer Test Lenses | 22 |
| No Preference | 2 |
| Slightly Prefer Control Lenses | 29 |
| Strongly Prefer Control Lenses | 4 |
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).
| mm | Ocufilcon D Then Ocufilcon B | Ocufilcon B Then Ocufilcon D |
|---|---|---|
| Lens Fit - Post-Blink Lens Movement After Insertion | 0.29 ± 0.28 | 0.3 ± 0.32 |
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).
| mm | Ocufilcon D Then Ocufilcon B | Ocufilcon B Then Ocufilcon D |
|---|---|---|
| Lens Fit - Post-Blink Lens Movement Prior to Removal | 0.38 ± 0.32 | 0.48 ± 0.41 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ocufilcon D | — | 0/50 (0%) | 0/50 (0%) |
| Ocufilcon B | — | 0/50 (0%) | 0/50 (0%) |
1 subject being disqualified after 1 week of wear
| Age, Categorical(Participants) | Ocufilcon D Then Ocufilcon B | Ocufilcon B Then Ocufilcon D | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 25 | 24 | 49 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Ocufilcon D Then Ocufilcon B | Ocufilcon B Then Ocufilcon D | Total |
|---|---|---|---|
| Female | 17 | 15 | 32 |
| Male | 8 | 9 | 17 |
| Region of Enrollment(participants) | Ocufilcon D Then Ocufilcon B | Ocufilcon B Then Ocufilcon D | Total |
|---|---|---|---|
| United States | 25 | 24 | 49 |
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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CooperVision International Limited (CVIL)