Myopia, Refractive Errors
Conditions
Keywords
Contact lenses
Brief summary
The purpose of the study is to evaluate the lens fit characteristics of delefilcon A contact lenses with different base curves and diameters.
Detailed description
Subjects will be expected to attend 4 office visits for an individual duration of participation of approximately 3 days.
Interventions
DEVICEDelefilcon A contact lenses with different base curves and diameters
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.
DEVICEDelefilcon A contact lenses with standard base curves and diameters
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.
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Successful wearer of spherical soft contact lenses in both eyes for a minimum of 5 days per week and a minimum of 6 hours per day during the past 3 months; * Able to wear contact lenses within a range of sphere powers from -2.00 and -4.00 diopters (D); * Best Corrected Visual Acuity (BCVA) (with manifest refraction) better than or equal to 0.10 logarithm Minimum Angle of Resolution (logMAR ) in each eye. Key
Exclusion criteria
* Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator; * History of refractive surgery or plan to have refractive surgery during the study, or irregular cornea in either eye; * Biomicroscopy findings at screening that are moderate (Grade 3) or higher and/or corneal vascularization that is mild (Grade 2) or higher; presence of corneal infiltrates. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Lenses Graded as Acceptably Tight, Optimal Fit, or Acceptably Loose at Dispense in Lens Movement (Overall Lens Fit) at Primary Gaze | Day 1 Dispense (Hour 0) of each study lens type worn during the corresponding crossover period | Lens movement was evaluated by the investigator using a slit lamp with the eye in primary gaze (looking straight ahead). Subject was asked to blink after which the investigator pushed up the lower lid margin to evaluate lens movement. Lens movement was 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). A grade of Acceptably Tight, Optimal Fit, or Acceptably Loose is considered to be acceptable lens fit. |
| Proportion of Lenses Graded as Acceptably Tight, Optimal Fit, or Acceptably Loose at Dispense in Lens Movement (Overall Lens Fit) at Peripheral Gazes | Day 1 Dispense (Hour 0) of each study lens type worn during the corresponding crossover period | Lens movement was evaluated by the investigator using a slit lamp with the eye in peripheral gaze (upward gaze, downward gaze, looking to the left, and looking to the right). Lens movement was assessed for each gaze 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). The overall lens fit grade was based on the worst-case scenario among the different gazes. A grade of Acceptably Tight, Optimal Fit, or Acceptably Loose is considered to be acceptable lens fit. |
| Proportion of Lenses Graded as Optimal Lens Centration or Acceptable Decentration at Dispense in Lens Position (Centration) | Day 1 Dispense (Hour 0) of each study lens type worn during the corresponding crossover period | Lens position was evaluated by the investigator using a slit lamp with the eye in primary position (relaxed, looking straight ahead). Lens position was graded on a 3-point scale as follows: 0 = Optimal centration; 1 = Acceptable decentration; 2 = Unacceptable decentration. A grade of Optimal Centration or Acceptable Decentration is considered to be acceptable centration. |
| 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 | Day 1, Hour 6 (+2) of each study lens type worn during the corresponding crossover period | Lens movement was evaluated by the investigator using a slit lamp with the eye in primary gaze (looking straight ahead). Subject was asked to blink after which the investigator pushed up the lower lid margin to evaluate lens movement. Lens movement was 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). A grade of Acceptably Tight, Optimal Fit, or Acceptably Loose is considered to be acceptable lens fit. |
| 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 | Day 1, Hour 6 (+2) of each study lens type worn during the corresponding crossover period | Lens movement was evaluated by the investigator using a slit lamp with the eye in peripheral gaze (upward gaze, downward gaze, looking to the left, and looking to the right). Lens movement was assessed for each gaze 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). The overall lens fit grade was based on the worst-case scenario among the different gazes. A grade of Acceptably Tight, Optimal Fit, or Acceptably Loose is considered to be acceptable lens fit. |
| Proportion of Lenses Graded as Optimal Lens Centration or Acceptable Decentration at 6 Hour Follow-up in Lens Position (Centration) | Day 1, Hour 6 (+2) of each study lens type worn during the corresponding crossover period | Lens position was evaluated by the investigator using a slit lamp with the eye in primary position (relaxed, looking straight ahead). Lens position was graded on a 3-point scale as follows: 0 = Optimal centration; 1 = Acceptable decentration; 2 = Unacceptable decentration. A grade of Optimal Centration or Acceptable Decentration is considered to be acceptable centration. |
Countries
United States
Contacts
STUDY_DIRECTORPrincipal Clinical Trial Lead, Vision Care
Alcon Research, LLC
Participant flow
Pre-assignment details
Of the 267 enrolled, 15 participants were screen failures. This reporting group includes all participants exposed to any study lenses evaluated in this study (252).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 32.2 years STANDARD_DEVIATION 9.6 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 90 Participants |
| Race/Ethnicity, Customized Black or African American | 11 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 8 Participants |
| Race/Ethnicity, Customized Multi-Racial | 5 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 232 Participants |
| Race/Ethnicity, Customized Other | 8 Participants |
| Race/Ethnicity, Customized White | 137 Participants |
| Sex: Female, Male Female | 170 Participants |
| Sex: Female, Male Male | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 252 | 0 / 502 | 0 / 251 | 0 / 504 | 0 / 252 |
| other Total, other adverse events | 0 / 252 | 0 / 502 | 0 / 251 | 0 / 504 | 0 / 252 |
| serious Total, serious adverse events | 0 / 252 | 0 / 502 | 0 / 251 | 0 / 504 | 0 / 252 |
Outcome results
None listed