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| Name | Class |
|---|---|
| Centre for Ocular Research & Education, Canada | OTHER |
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The purpose of this study was to compare the clinical performance of two different reusable lenses in habitual spherical soft lens wearers.
This study was a prospective, bilateral eye, double-masked, randomized, 1 month cross-over, daily-wear design involving two different frequent replacement type lenses. Duration of involvement for each participant was approximately 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lens A, then Lens B | Experimental | Participants wore Lens A for one month and then Lens B for one month. |
|
| Lens B, then Lens A | Experimental | Participants wore Lens B one month and then Lens A for one month. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lens A (fanfilcon A) | Device | Daily wear for one month |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lens Handling on Removal | Participants measured subjective lens handling at removal on a 0-100 integer scale, where 0=worst and 100=best. Results for each lens were collected in the at-home diary on Day 27. | Day 27 |
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Inclusion Criteria:
Were at least 18 years of age and no older than 39 years, and had full legal capacity to volunteer;
Had read and signed an information consent letter;
Were willing and able to follow instructions and maintain the appointment schedule;
Self-reported having had a full eye examination in the previous two years;
Had healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator;
Anticipated being able to wear the study lenses for at least 8 hours a day, 6 days a week;
Habitually wore spherical soft contact lenses, for the past 3 months minimum:
It was preferred that all participants were habitual frequent replacement lens wearers. However, if this was not possible then no more than 5 participants could be habitual daily disposable lens wearers at each site, the rest had to be habitual frequent replacement lens wearers;
- For the frequent replacement wearers: No more than 3 could be habitual wearers of the Avaira Vitality™/ Serenity™ brand (or their equivalent private label brand name) and no more than 3 could be habitual wearers of AIR OPTIX® plus HydraGlyde® can be enrolled at each site;
Had refractive astigmatism no higher than -0.75DC in each eye;
Could be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere +6.00 to -6.00D, 0.25D steps).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolyn MacNeil | Insight Eye Care | Principal Investigator |
| Abigail Gillogly-Harsch | Nittany Eye Associates | Principal Investigator |
| Roxanne Achong-Coan | Coan Eye Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coan Eye Care | Ocoee | Florida | 34761 | United States | ||
| Nittany Eye Associates |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lens A, Then Lens B | Participants wore Lens A for one month and then Lens B for one month. |
| FG001 | Lens B, Then Lens A | Participants wore Lens B for one month and then Lens A for one month. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: First Intervention 28-32 Days |
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| |||||||||||||||||||||
| Period 2: Second Intervention 28-32 Days |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Study Population | All participants that were dispensed intervention (Lens A or Lens B), regardless of eligibility or study completion |
| 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 | Lens Handling on Removal | Participants measured subjective lens handling at removal on a 0-100 integer scale, where 0=worst and 100=best. Results for each lens were collected in the at-home diary on Day 27. | Analysis population includes all participants that were eligible (inclusion/exclusion criteria) and completed all study visits. Of 50 participants that completed the study, 1 was removed from the analysis due to a symptomatic adverse event at the final study visit which may have impacted the study data. | Posted | Mean | Standard Deviation | score on a scale | Day 27 |
|
The duration of the clinical trial, approximately 2-3 months
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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 | Lens A | Participants that received Lens A | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral conjunctivitis | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| José A. Vega, O.D., MSc., PhD, FAAO | CooperVision Inc. | 925-621-3761 | JVega2@coopervision.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 15, 2023 | Jul 23, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Lens B (lotrafilcon B) | Device | Daily wear for one month |
|
| State College |
| Pennsylvania |
| 16801 |
| United States |
| Insight Eye Care | Waterloo | Ontario | N2L 3S1 | Canada |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Participants that received Lens B during either the first or second period of the study |
|
|
| 50 |
| 0 |
| 50 |
| 5 |
| 50 |
| EG001 | Lens B | Participants that received Lens B | 0 | 50 | 0 | 50 | 4 | 50 |
| Ocular discomfort, | Eye disorders | Systematic Assessment |
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| Asymptomatic corneal infiltrate event | Eye disorders | Systematic Assessment |
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| Lower lid small chalazion | Eye disorders | Systematic Assessment |
|
| Nasal upper lid papilloma | Eye disorders | Systematic Assessment |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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