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This will be a controlled and randomized, single-masked, crossover study in which 48 subjects will use the Biofinity Contact Lens (comfilcon A) with each of the two lens care products ('solutions'), (Synergi and Biotrue Multi-purpose Solution) for one month each. Follow-up visits for each solution will take place at one week, two weeks and four weeks: with a one-week 'wash-out' period between the solutions. Key outcome measures for this study include biomicroscopic and subjective responses to the lens/solution combinations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synergi / comfilcon A | Active Comparator | Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study. |
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| Biotrue / comfilcon A | Active Comparator | Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| comfilcon A | Device | soft contact lens |
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| Measure | Description | Time Frame |
|---|---|---|
| Conjunctival Hyperaemia | 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. | Baseline, 1 week, 2 weeks, 4 weeks |
| Limbal Hyperaemia | 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. | Baseline, 1 week, 2 weeks, 4 weeks |
| Corneal Staining | 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. | Baseline, 1 week, 2 weeks, 4 weeks |
| Papillary Conjunctivitis | 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. | Baseline, 1 week, 2 weeks, 4 weeks |
| Comfort | Subjective 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. | 1 week |
| Comfort | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carole Maldonado-Codina | University of Manchester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurolens Research | Manchester | M13 9PL | United Kingdom |
Three subjects were not dispensed the combination of multipurpose solutions.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (4 Weeks) |
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| Washout (1 Week) |
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| Second Intervention (4 Weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Baseline Characteristics | 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. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Conjunctival Hyperaemia | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1 week, 2 weeks, 4 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Synergi/Comfilcon A Combo, Then Biotrue/Comfilcon A Combo | 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: Multipurpose solution |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Manager Global Medical Scientific Affairs | CooperVision | (925) 621-3761 | javega@coopervision.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Synergi | Device | Multipurpose solution |
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| Biotrue | Device | Multipurpose solution |
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| stenfilcon A | Other | daily disposable contact lenses for washout period |
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| 2 weeks |
| Comfort | 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. | 4 weeks |
| Vision | 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. | 1 week |
| Vision | 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. | 2 weeks |
| Vision | 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. | 4 weeks |
| Dryness | Subjective 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. | 1 week, 2 weeks, 4 weeks |
| Burning/Stinging | Subjective 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. | 1 week, 2 weeks, 4 weeks |
| Ocular Redness | 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. | 1 week, 2 weeks, 4 weeks |
| Ease of Lens Insertion | 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. | 1 week, 2 weeks, 4 weeks |
| Ease of Lens Removal | 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. | 1 week, 2 weeks, 4 weeks |
| Ease of Use of Solution | Subjective 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 | 1 week, 2 weeks, 4 weeks |
| Overall Score | 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. | 1 week, 2 weeks, 4 weeks |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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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 |
|
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| Primary | Limbal Hyperaemia | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1 week, 2 weeks, 4 weeks |
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| Primary | Corneal Staining | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1 week, 2 weeks, 4 weeks |
|
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| Primary | Papillary Conjunctivitis | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1 week, 2 weeks, 4 weeks |
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| Primary | Comfort | Subjective 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. | Posted | Mean | Standard Deviation | units on a scale | 1 week |
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| Primary | Comfort | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
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| Primary | Comfort | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
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| Primary | Vision | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 1 week |
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| Primary | Vision | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
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| Primary | Vision | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
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| Primary | Dryness | Subjective 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. | Posted | Mean | Standard Deviation | units on a scale | 1 week, 2 weeks, 4 weeks |
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| Primary | Burning/Stinging | Subjective 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. | Posted | Mean | Standard Deviation | units on a scale | 1 week, 2 weeks, 4 weeks |
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| Primary | Ocular Redness | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 1 week, 2 weeks, 4 weeks |
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| Primary | Ease of Lens Insertion | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 1 week, 2 weeks, 4 weeks |
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| Primary | Ease of Lens Removal | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 1 week, 2 weeks, 4 weeks |
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| Primary | Ease of Use of Solution | Subjective 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 | Posted | Mean | Standard Deviation | units on a scale | 1 week, 2 weeks, 4 weeks |
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| Primary | Overall Score | 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. | Data not collected as follows: 2 weeks (1 participant) and 4 weeks (1 participant - Synergi, 1 participant - Biotrue). | Posted | Mean | Standard Deviation | units on a scale | 1 week, 2 weeks, 4 weeks |
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| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Biotrue/Comfilcon A Combo, Then Synergi/Comfilcon A Combo | 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 Synergi: Multipurpose solution | 0 | 27 | 0 | 27 |
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| 1 week |
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| 2 weeks |
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| 4 weeks |
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| 4 weeks |
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| Overall comfort |
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| Overall comfort |
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| Variable vision |
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| Night vision |
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| Variable vision |
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| Night vision |
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| Variable vision |
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| Night vision |
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| 4 weeks |
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| 4 weeks |
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