Myopia
Conditions
Brief summary
The purpose of this study was to assess the impact of lens-free (recovery) intervals of varying lengths on end-of-day comfort and tear film changes with daily contact lens wear.
Detailed description
This study was conducted in a cross-over design with two phases. Each phase consisted of four cycles approximately 12 hours in length. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear. A 12-hour lens-free wear period preceded each phase.
Interventions
DEVICELotrafilcon B
Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.
DEVICESenofilcon A
Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.
Sponsors
University of Waterloo
CIBA VISION
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is at least 17 years of age and has full legal capacity to volunteer. * Is willing and able to follow instructions and maintain the appointment schedule. * Has had an ocular examination in the last two years. * Is an adapted soft contact lens wearer. * Experiences a decrease in ocular comfort through a lens-wearing day. * Has a current pair of spectacles. * Has a distance contact lens prescription of +6.00 diopters to -10.00 diopters and an acceptable fit with the study lenses. * Has astigmatism less than or equal to -1.00 DC. * Achieves visual acuity of 6/9 or better with the study lenses and with habitual spectacles. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Has any ocular disease. * Has a systemic condition that may affect a study outcome variable. * Is using any systemic or topical medications that may affect ocular health. * Has known sensitivity to the diagnostic pharmaceuticals to be used in the study. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean End-of-Day Comfort | Hour 12 | As assessed by the participant using a visual analog scale ranging from 0 (extremely uncomfortable) to 100 (very comfortable and fresh) at the end of each 12-hour (approximate) cycle. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Non-Invasive Tear Film Break-Up Time (NITBUT) | Hour 12 | As assessed by the investigator using a corneal topographer. NITBUT was assessed at the end of each 12-hour (approximate) cycle. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear. A longer tear film break-up time indicates a more stable tear film and may lead to a more comfortable lens-wearing experience. |
Countries
Canada
Participant flow
Recruitment details
Participants were recruited from one study center located in Canada.
Pre-assignment details
Of the 44 participants enrolled, 16 were exited from the study prior to randomization (screen failures). Three subjects were randomized/fitted with lenses but discontinued prior to product dispense. This reporting group includes all participants enrolled and dispensed product. A 12-hour lens-free wear period preceded each phase.
Participants by arm
| Arm | Count |
|---|---|
| Overall Lotrafilcon B and Senofilcon A worn in cross-over fashion as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days). | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Phase 2: Second Study Product | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Customized | 25 years |
| Region of Enrollment Canada | 25 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 28 | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
Primary
Mean End-of-Day Comfort
As assessed by the participant using a visual analog scale ranging from 0 (extremely uncomfortable) to 100 (very comfortable and fresh) at the end of each 12-hour (approximate) cycle. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear.
Time frame: Hour 12
Population: All participants who participated in both phases of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lotrafilcon B | Mean End-of-Day Comfort | Six 2-hr wear intervals/0-min recovery intervals | 48.9 Units on a scale | Standard Deviation 17.8 |
| Lotrafilcon B | Mean End-of-Day Comfort | Five 2-hr wear intervals/30-min recovery intervals | 51.4 Units on a scale | Standard Deviation 17.6 |
| Lotrafilcon B | Mean End-of-Day Comfort | Four 2-hr wear intervals/60-min recovery intervals | 56.0 Units on a scale | Standard Deviation 19.8 |
| Lotrafilcon B | Mean End-of-Day Comfort | Four 2-hr wear intervals/80-min recovery intervals | 51.5 Units on a scale | Standard Deviation 13.1 |
| Senofilcon A | Mean End-of-Day Comfort | Four 2-hr wear intervals/80-min recovery intervals | 58.8 Units on a scale | Standard Deviation 18 |
| Senofilcon A | Mean End-of-Day Comfort | Six 2-hr wear intervals/0-min recovery intervals | 56.0 Units on a scale | Standard Deviation 15.9 |
| Senofilcon A | Mean End-of-Day Comfort | Four 2-hr wear intervals/60-min recovery intervals | 58.8 Units on a scale | Standard Deviation 13.9 |
| Senofilcon A | Mean End-of-Day Comfort | Five 2-hr wear intervals/30-min recovery intervals | 53.7 Units on a scale | Standard Deviation 15.9 |
Secondary
Mean Non-Invasive Tear Film Break-Up Time (NITBUT)
As assessed by the investigator using a corneal topographer. NITBUT was assessed at the end of each 12-hour (approximate) cycle. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear. A longer tear film break-up time indicates a more stable tear film and may lead to a more comfortable lens-wearing experience.
Time frame: Hour 12
Population: All participants who participated in both phases of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lotrafilcon B | Mean Non-Invasive Tear Film Break-Up Time (NITBUT) | Six 2-hr wear intervals/0-min recovery intervals | 4.6 Seconds | Standard Deviation 1.9 |
| Lotrafilcon B | Mean Non-Invasive Tear Film Break-Up Time (NITBUT) | Five 2-hr wear intervals/30-min recovery intervals | 5.3 Seconds | Standard Deviation 2.2 |
| Lotrafilcon B | Mean Non-Invasive Tear Film Break-Up Time (NITBUT) | Four 2-hr wear intervals/60-min recovery intervals | 4.4 Seconds | Standard Deviation 2.2 |
| Lotrafilcon B | Mean Non-Invasive Tear Film Break-Up Time (NITBUT) | Four 2-hr wear intervals/80-min recovery intervals | 4.9 Seconds | Standard Deviation 2.6 |
| Senofilcon A | Mean Non-Invasive Tear Film Break-Up Time (NITBUT) | Four 2-hr wear intervals/80-min recovery intervals | 4.8 Seconds | Standard Deviation 2.2 |
| Senofilcon A | Mean Non-Invasive Tear Film Break-Up Time (NITBUT) | Six 2-hr wear intervals/0-min recovery intervals | 4.3 Seconds | Standard Deviation 1.2 |
| Senofilcon A | Mean Non-Invasive Tear Film Break-Up Time (NITBUT) | Four 2-hr wear intervals/60-min recovery intervals | 4.4 Seconds | Standard Deviation 2.4 |
| Senofilcon A | Mean Non-Invasive Tear Film Break-Up Time (NITBUT) | Five 2-hr wear intervals/30-min recovery intervals | 4.7 Seconds | Standard Deviation 2.4 |