Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to evaluate the lens fit characteristics of delefilcon A contact lenses with different base curves and diameters.
Subjects will be expected to attend 4 office visits for an individual duration of participation of approximately 3 days.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LID023681, then LID006961 | Other | Delefilcon A contact lenses with different base curves and diameters worn in Period 1, followed by delefilcon A contact lenses with standard base curves and diameters worn in Period 2. During each period, the contact lenses will be worn bilaterally (in both eyes) for 6 (+2) hours. A one-to-two day washout will separate the wear periods. |
|
| LID006961, then LID023681 | Other | Delefilcon A contact lenses with standard base curves and diameters worn in Period 1, followed by delefilcon A contact lenses with different base curves and diameters worn in Period 2. During each period, the contact lenses will be worn bilaterally (in both eyes) for 6 (+2) hours. A one-to-two day washout will separate the wear periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delefilcon A contact lenses with different base curves and diameters | Device | Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of lenses graded as Acceptably Tight, Optimal Fit, or Acceptably Loose at Dispense in lens movement (overall lens fit) at primary gaze | Lens movement (overall lens fit) will be evaluated by the investigator using a slit lamp with the eye in primary position. Lens movement (overall lens fit) will be graded on a 5-point scale as follows: -2 = unacceptably tight (reduced movement, unacceptable); -1 = Acceptably tight (reduced movement, acceptable); 0 = Optimal fit / movement; +1 = Acceptably loose (excessive movement, acceptable); +2 = Unacceptably loose (excessive movement, unacceptable). | Day 1 Dispense (Hour 0) of each study lens type worn during the corresponding crossover period |
| Proportion of lenses graded as Acceptably Tight, Optimal Fit, or Acceptably Loose at Dispense in lens movement (overall lens fit) at peripheral gazes | Lens movement (overall lens fit) will be evaluated by the investigator using a slit lamp with the eye in upward gaze, downward gaze, looking to the left, and looking to the right. Lens movement (overall lens fit) for each gaze will be graded on a 5-point scale as follows: -2 = unacceptably tight (reduced movement, unacceptable); -1 = Acceptably tight (reduced movement, acceptable); 0 = Optimal fit / movement; +1 = Acceptably loose (excessive movement, acceptable); +2 = Unacceptably loose (excessive movement, unacceptable). | Day 1 Dispense (Hour 0) of each study lens type worn during the corresponding crossover period |
| Proportion of lenses graded as Optimal Lens Centration or Acceptable Decentration at Dispense in lens position (centration) | Lens position (centration) will be evaluated by the investigator using a slit lamp with the eye in primary position. Lens position (centration) will be graded on a 3-point scale as follows: 0 = Optimal centration; 1 = Acceptable centration; 2 = Unacceptable decentration. | Day 1 Dispense (Hour 0) of each study lens type worn during the corresponding crossover period |
| Proportion of lenses graded as Acceptably Tight, Optimal Fit, or Acceptably Loose at 6 Hour Follow-up in lens movement (overall fit) at primary gaze |
Not provided
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Principal Clinical Trial Lead, Vision Care | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kurata Eyecare Center | Los Angeles | California | 90013 | United States | ||
| Elsa Pao, OD |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Delefilcon A contact lenses with standard base curves and diameters | Device | Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity. |
|
|
Lens movement (overall lens fit) will be evaluated by the investigator using a slit lamp with the eye in primary position. Lens movement (overall lens fit) will be graded on a 5-point scale as follows: -2 = unacceptably tight (reduced movement, unacceptable); -1 = Acceptably tight (reduced movement, acceptable); 0 = Optimal fit / movement; +1 = Acceptably loose (excessive movement, acceptable); +2 = Unacceptably loose (excessive movement, unacceptable). |
| Day 1, Hour 6 (+2) of each study lens type worn during the corresponding crossover period |
| Proportion of lenses graded as Acceptably Tight, Optimal Fit, or Acceptably Loose at 6 Hour Follow-up in lens movement (overall fit) at peripheral gazes | Lens movement (overall lens fit) will be evaluated by the investigator using a slit lamp with the eye in upward gaze, downward gaze, looking to the left, and looking to the right. Lens movement (overall lens fit) for each gaze will be graded on a 5-point scale as follows: -2 = unacceptably tight (reduced movement, unacceptable); -1 = Acceptably tight (reduced movement, acceptable); 0 = Optimal fit / movement; +1 = Acceptably loose (excessive movement, acceptable); +2 = Unacceptably loose (excessive movement, unacceptable). | Day 1, Hour 6 (+2) of each study lens type worn during the corresponding crossover period |
| Proportion of lenses graded as Optimal Lens Centration or Acceptable Decentration at 6 Hour Follow-up in lens position (centration) | Lens position (centration) will be evaluated by the investigator using a slit lamp with the eye in primary position. Lens position (centration) will be graded on a 3-point scale as follows: 0 = Optimal centration; 1 = Acceptable centration; 2 = Unacceptable decentration. | Day 1, Hour 6 (+2) of each study lens type worn during the corresponding crossover period |
| Oakland |
| California |
| 94607 |
| United States |
| Pacific Rims Optometry | San Francisco | California | 94127 | United States |
| Pearson Research Center, PA | Longwood | Florida | 32779 | United States |
| Kindred Optics at Maitland Vision | Maitland | Florida | 32751 | United States |
| Eyeconic Family Eyecare | Dallas | Georgia | 30157 | United States |
| Dr. Schwartz Optometrist and Associates | Sterling Heights | Michigan | 48312 | United States |
| Coldwater Vision Research | Coldwater | Mississippi | 38618 | United States |
| SUNY College of Optometry Clinical Vision Research Center | New York | New York | 10036 | United States |
| NC Eye Associates, OD, PLLC | Apex | North Carolina | 27502 | United States |
| See Eye Care Optometry | Charlotte | North Carolina | 28278 | United States |
| ProCare Vision Centers, Inc. | Granville | Ohio | 43023 | United States |
| Eyecare Professionals, Inc | Powell | Ohio | 43065 | United States |
| Wyomissing Optometric Center | Wyomissing | Pennsylvania | 19610 | United States |
| West Bay Eye Associates | Warwick | Rhode Island | 02888 | United States |
| Southern College of Optometry | Memphis | Tennessee | 38104 | United States |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
Not provided
Not provided