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The purpose of this study is to compare the subjective performance for handling of two daily disposable contact lenses, stenfilcon A and etafilcon A.
The study is to compare the subjective performance for handling of two daily disposable contact lenses, stenfilcon A and etafilcon A in this cross-over study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stenfilcon A | Experimental | Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. |
|
| etafilcon A | Active Comparator | Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A | Device | Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Handling | Participant's subjective rating for lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10= very easy). | two weeks and four weeks from baseline visit |
| Satisfaction With Handling | Participant's subjective rating for overall satisfaction of lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied). | two weeks and four weeks from baseline visit |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort | Participant's subjective rating for overall lens comfort of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10=can't feel). | two weeks and four weeks from baseline visit |
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Inclusion Criteria:-
Exclusion Criteria:-
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| Name | Affiliation | Role |
|---|---|---|
| Graeme Young | Visioncare Research Ltd. | Study Director |
| Ruth Craven | Visioncare Research Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keith Tempany Opticians | Broadstone | Dorset | MH18 | United Kingdom | ||
| Cameron-Davies Optometrists |
All participants randomized to receive all interventions and combined into one Arm/Group, "Overall All Study Population" for the participant flow.
Number subjects enrolled per site ranged six to 25. Two sites were asked to enroll more than 20 subjects to fulfill required number of subjects. Approval from Ethics Committee sought before sites were invited to recruit additional subjects. Of the 100 enrolled, 13 were existing etafilcon A wearers, falling short of the 25% target.
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| ID | Title | Description |
|---|---|---|
| FG000 | Stenfilcon A Then Etafilcon A | All subjects assigned as overall study population wore both sets of lenses. Overall study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A. |
| FG001 | Etafilcon A Then Stenfilcon A | All subjects assigned as overall study population wore both sets of lenses. Study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All subjects assigned as overall study population wore both sets of lenses. Study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.
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| ID | Title | Description |
|---|---|---|
| BG000 | Stenfilcon A Then Etafilcon A | All subjects assigned as overall study population wore both sets of lenses. Overall study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A. |
| BG001 | Etafilcon A Then Stenfilcon A |
| 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 | Handling | Participant's subjective rating for lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10= very easy). | Posted | Mean | Standard Deviation | units on a scale | two weeks and four weeks from baseline visit |
|
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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 | Stenfilcon A | Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Graeme Young | Visioncare Research Ltd. | 01252 718719 | 207 | g.young@visioncare.co.uk |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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|
| stenfilcon A | Device | Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. |
|
|
| Dryness |
Participant's subjective rating for overall lens dryness of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10=no dryness). |
| two weeks and four weeks from baseline visit |
| Satisfaction With Dryness | Participant's subjective rating for overall satisfaction of lens dryness of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied). | two weeks and four weeks from baseline visit |
| Satisfaction With Comfort | Participant's subjective rating for overall satisfaction of lens comfort of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied). | two weeks and four weeks from baseline visit |
| Southsea |
| Hampshire |
| PO5 2AT |
| United Kingdom |
| Cameron-Davies Optometrists | Portchester | Hants | PO16 9UN | United Kingdom |
| Leightons Opticians | St Albans | Hertfordshire | AL1 3LH | United Kingdom |
| David Gould Opticians | Rawtenstall | Lancashire | BB4 7QN | United Kingdom |
| Vision Express Optical Lab | Hendon | London | NW4 3FB | United Kingdom |
| S.H. Harrold | Uxbridge | London | UB8 1JX | United Kingdom |
All subjects assigned as overall study population wore both sets of lenses. Overall study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
|
|
| Secondary | Comfort | Participant's subjective rating for overall lens comfort of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10=can't feel). | Posted | Mean | Standard Deviation | units on a scale | two weeks and four weeks from baseline visit |
|
|
|
| Secondary | Dryness | Participant's subjective rating for overall lens dryness of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10=no dryness). | Posted | Mean | Standard Deviation | units on a scale | two weeks and four weeks from baseline visit |
|
|
|
| Primary | Satisfaction With Handling | Participant's subjective rating for overall satisfaction of lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied). | Posted | Number | percentage of participants | two weeks and four weeks from baseline visit |
|
|
|
| Secondary | Satisfaction With Dryness | Participant's subjective rating for overall satisfaction of lens dryness of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied). | Posted | Number | percentage of participants | two weeks and four weeks from baseline visit |
|
|
|
| Secondary | Satisfaction With Comfort | Participant's subjective rating for overall satisfaction of lens comfort of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied). | Posted | Number | percentage of participants | two weeks and four weeks from baseline visit |
|
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| 0 |
| 100 |
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | Etafilcon A | Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. | 0 | 100 | 0 | 100 | 0 | 100 |
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.
| Neither |
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| Somwhat Dissatisfied |
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| Completely Dissatisfied |
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| Neither |
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| Somwhat Dissatisfied |
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| Completely Dissatisfied |
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| Neither |
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| Somwhat Dissatisfied |
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| Completely Dissatisfied |
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