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The primary objective of thes study is to confirm that the ocular response to the Test lenses are similar to those of the Control lenses when used in a 1 week planned replacement, daily wear modality over a 1-month period.
The test lens and control lens were randomized in a 2:1 ratio to evaluate the test lens and control contact lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| enfilcon A | Experimental | The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality. |
|
| galyfilcon A | Active Comparator | The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enfilcon A | Device |
|
| |
| galyfilcon A |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Assessment: Ocular Response - Biomicroscopy | The primary safety endpoint are the objective slit lamp findings associated with the enfilcon A contact lenses compared with those same findings reported as associated with the galyfilcon A contact lenses. The incidence of biomicroscopy findings (0=not present, 4=severe) over the duration of the study with the highest reported grade was chosen for each unique eye. Biomicroscopy measurements were obtained at Baseline/Dispensing (baseline and dispensing visit combined), Post-Dispensing (after lenses were dispensed and allowed to settle) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit combined). The average grade for unique eyes with findings greater than 0 (none) is compared. | Change from baseline/dispensing visits, post-dispensing visit and all follow-ups visits |
| Comparison of Objective Findings - Number of Adverse Events in Unique Eyes | The primary safety endpoint are the objective findings of the number of adverse events in unique eyes associated with the enfilcon A contact lenses compared with those same findings as associated with the galyfilcon A contact lenses. The number of adverse events over the duration of the study was reported for each unique eye (bilateral or unilateral). Observations for adverse events were reported for any occurrence from Baseline through end of month 1 visit. | Any occurrence from baseline to 1 month visit |
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Inclusion Criteria:
Prior to being considered eligible to participate in this study, each subject MUST:
Exclusion Criteria:
Subjects may not be enrolled in this study if any of the following apply: The subject is/has:
To be eligible to be randomized for study product a subject must have ALL of the Inclusion Criteria and have NONE of the exclusion criteria present.
To be eligible for lens dispensing (either Test or Control), the subject's study lens contact lens visual acuity must be equal to or better than 20/30 in each eye.
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| Name | Affiliation | Role |
|---|---|---|
| Scott E Schachter, OD | Unafiliated | Principal Investigator |
| Cheryl Vincent-Reimer, OD | Unafiliated | Principal Investigator |
| Eric White, OD | Unafiliated | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Eyecare | Pismo Beach | California | 93449 | United States | ||
| Eric M. White, OD, Inc. |
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52 subjects evaluated. Of these 52 subjects, 2 found ineligible and not randomized resulting in 50 subjects randomized, 33 test, 17 control. Of 50 subjects randomized, 2 discontinued and not included in results data, 31 test, 17 control, 1 lost to follow-up, 1 Sponsor/IRB decision due to pregnancy at one month visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Enfilcon A | The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality. |
| FG001 | Galyfilcon A | The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Enfilcon A | The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality. |
| BG001 | Galyfilcon A | The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality. |
| 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 | Objective Assessment: Ocular Response - Biomicroscopy | The primary safety endpoint are the objective slit lamp findings associated with the enfilcon A contact lenses compared with those same findings reported as associated with the galyfilcon A contact lenses. The incidence of biomicroscopy findings (0=not present, 4=severe) over the duration of the study with the highest reported grade was chosen for each unique eye. Biomicroscopy measurements were obtained at Baseline/Dispensing (baseline and dispensing visit combined), Post-Dispensing (after lenses were dispensed and allowed to settle) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit combined). The average grade for unique eyes with findings greater than 0 (none) is compared. | Unique eyes are defined as each individual eye in the study and are only counted once for each of the visit groupings. | Posted | Mean | Full Range | units on a scale | Change from baseline/dispensing visits, post-dispensing visit and all follow-ups visits | unique eyes | unique eyes |
|
From dispense up to one month on both the study lenses, a total of two 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 | Enfilcon A | The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Temporary Discontinuation of Lens Wear | Eye disorders | Non-systematic Assessment | Single (one subject), bilateral event reported for the control group at day 21 as temporary discontinuation lens wear of 1 day. Subject napped with lenses in place. Awoke with red eyes. Removed the lenses for the remainder of the day. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William J. Gleason, O.D. | Foresight Regulatory Strategies, Inc. | (978) 658-6888 | 151 |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Device |
|
|
| San Diego |
| California |
| 48823 |
| United States |
| Vision Care Associates | East Lansing | Michigan | 48823 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Enfilcon A |
The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality. |
| OG001 | Galyfilcon A | The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality. |
|
|
| Primary | Comparison of Objective Findings - Number of Adverse Events in Unique Eyes | The primary safety endpoint are the objective findings of the number of adverse events in unique eyes associated with the enfilcon A contact lenses compared with those same findings as associated with the galyfilcon A contact lenses. The number of adverse events over the duration of the study was reported for each unique eye (bilateral or unilateral). Observations for adverse events were reported for any occurrence from Baseline through end of month 1 visit. | Unique eyes are defined as each individual eye in the study. | Posted | Number | number of adverse events | Any occurrence from baseline to 1 month visit | eyes | eyes |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Galyfilcon A | The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality. | 0 | 17 | 0 | 17 | 1 | 17 |
|
Release of this data (through presentation, publication or other written or oral communication) to other than listed personnel (see protocol) requires the prior written permission from the study Sponsor. Study investigators and all office personnelare prohibited from acknowledging participation in the study to individuals and organizations except those listed.