Myopia
Conditions
Brief summary
The aim of this study is to compare the subjective performance of the comfilcon A contact lens against lotrafilcon B contact lens after 4 weeks of reusable lens wear.
Detailed description
This will be a 80 subject, randomized, bilateral, double-masked, dispensing, cross-over study comparing comfilcon A versus lotrafilcon B lenses over 4 weeks of daily wear for each lens pair.
Interventions
DEVICEcomfilcon A
contact lens
DEVICElotrafilcon B
contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 34 Years
Healthy volunteers
Yes
Inclusion criteria
* Spherical distance CL (Contact Lens) prescription between -1.00 and -6.00D (Diopter) OR in both eyes (inclusive) * Adapted soft CL wearers (i.e. \>1 month) who are reusable lens wearers\* * Spectacle cylinder 0.75D in both eyes * Correctable to 6/9 in both eyes * Be between 18 and 34 years of age (inclusive) * Able to read, comprehend and sign an informed consent * Own a mobile phone and be able to respond to SMS survey during the period 8am - 8pm * Willing to comply with the wear and study visit schedule
Exclusion criteria
Any of the following will render a subject ineligible for inclusion: * Existing wearer of daily disposable contact lenses * Known allergy to Opti-Free PureMoist multipurpose solution * Any active corneal infection, injury or inflammation * Systemic or ocular allergies, which might interfere with CL wear * Systemic disease, which might interfere with CL wear * Ocular disease, which might interfere with CL wear * Strabismus or amblyopia * Subjects who have undergone corneal refractive surgery * Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear * Pregnant, planning a pregnancy or lactating * Use of systemic/topical medication contraindicating CL wear * Diabetic * Site employees or family members of investigators * Participation in any concurrent trial or in the last 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort | Baseline, 2 weeks, 4 weeks | Comfort (insertion, end of the day, and overall) for habitual lenses assessed at baseline and comfilcon A and lotrafilcon B lenses assessed at 2 weeks and 4 weeks. Scale 0-10, 0=painful, 10=can't feel the lenses. |
| Comfort During the Day | Days 3, 12, 26 | Comfort during the day for comfilcon A and lotrafilcon B lenses assessed via via SMS (short message service) text message at days 3,12, and 26 at hours 8:00 am, 12:00 pm, 4:00 pm, and 8:00 pm. Scale 0-10, 0=painful, 10=can't feel the lenses. |
Countries
United Kingdom
Participant flow
Pre-assignment details
Four subjects were not dispensed lenses due to screen failure. Seven subjects discontinued from the study due to the investigational site withdrawing from the study.
Participants by arm
| Arm | Count |
|---|---|
| Overall Participants Participants wear comfilcon A and lotrafilcon B lens for 4 weeks during the cross over study.
comfilcon A: contact lens
lotrafilcon B: contact lens | 74 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (4 Weeks) | Discomfort | 1 | 0 |
| First Intervention (4 Weeks) | Lost to Follow-up | 1 | 0 |
| First Intervention (4 Weeks) | Poor fitting characteristics | 0 | 1 |
| Second Intervention (4 Weeks) | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Overall Participants |
|---|---|
| Age, Continuous | 26.5 years STANDARD_DEVIATION 4.5 |
| Sex: Female, Male Female | 51 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 74 | 0 / 74 |
| other Total, other adverse events | 0 / 74 | 0 / 74 |
| serious Total, serious adverse events | 0 / 74 | 0 / 74 |
Outcome results
Primary
Comfort
Comfort (insertion, end of the day, and overall) for habitual lenses assessed at baseline and comfilcon A and lotrafilcon B lenses assessed at 2 weeks and 4 weeks. Scale 0-10, 0=painful, 10=can't feel the lenses.
Time frame: Baseline, 2 weeks, 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Habitual (Baseline) | Comfort | Overall comfort | 8.86 units on a scale | Standard Deviation 1.38 |
| Habitual (Baseline) | Comfort | Comfort on insertion | 8.90 units on a scale | Standard Deviation 1.38 |
| Habitual (Baseline) | Comfort | End-of-Day Comfort | 8.03 units on a scale | Standard Deviation 1.78 |
| Comfilcon A (2 Weeks) | Comfort | Comfort on insertion | 9.03 units on a scale | Standard Deviation 1.1 |
| Comfilcon A (2 Weeks) | Comfort | End-of-Day Comfort | 7.31 units on a scale | Standard Deviation 2.21 |
| Comfilcon A (2 Weeks) | Comfort | Overall comfort | 8.13 units on a scale | Standard Deviation 1.69 |
| Lotrafilcon B (2 Weeks) | Comfort | Comfort on insertion | 8.70 units on a scale | Standard Deviation 1.57 |
| Lotrafilcon B (2 Weeks) | Comfort | Overall comfort | 8.43 units on a scale | Standard Deviation 1.54 |
| Lotrafilcon B (2 Weeks) | Comfort | End-of-Day Comfort | 7.45 units on a scale | Standard Deviation 2.23 |
| Comfilcon A (4 Weeks) | Comfort | End-of-Day Comfort | 7.23 units on a scale | Standard Deviation 2.17 |
| Comfilcon A (4 Weeks) | Comfort | Comfort on insertion | 8.74 units on a scale | Standard Deviation 1.25 |
| Comfilcon A (4 Weeks) | Comfort | Overall comfort | 8.11 units on a scale | Standard Deviation 1.57 |
| Lotrafilcon B (4 Weeks) | Comfort | Overall comfort | 8.24 units on a scale | Standard Deviation 1.65 |
| Lotrafilcon B (4 Weeks) | Comfort | Comfort on insertion | 8.60 units on a scale | Standard Deviation 1.62 |
| Lotrafilcon B (4 Weeks) | Comfort | End-of-Day Comfort | 7.34 units on a scale | Standard Deviation 2.34 |
Primary
Comfort During the Day
Comfort during the day for comfilcon A and lotrafilcon B lenses assessed via via SMS (short message service) text message at days 3,12, and 26 at hours 8:00 am, 12:00 pm, 4:00 pm, and 8:00 pm. Scale 0-10, 0=painful, 10=can't feel the lenses.
Time frame: Days 3, 12, 26
Population: Missing data from one participant.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Habitual (Baseline) | Comfort During the Day | 4:00 pm | 8.51 units on a scale | Standard Deviation 1.58 |
| Habitual (Baseline) | Comfort During the Day | 12:00 pm | 8.94 units on a scale | Standard Deviation 1.48 |
| Habitual (Baseline) | Comfort During the Day | 8:00 pm | 8.15 units on a scale | Standard Deviation 1.94 |
| Habitual (Baseline) | Comfort During the Day | 8:00 am | 8.98 units on a scale | Standard Deviation 1.34 |
| Comfilcon A (2 Weeks) | Comfort During the Day | 12:00 pm | 8.95 units on a scale | Standard Deviation 1.22 |
| Comfilcon A (2 Weeks) | Comfort During the Day | 8:00 pm | 8.14 units on a scale | Standard Deviation 1.59 |
| Comfilcon A (2 Weeks) | Comfort During the Day | 8:00 am | 8.78 units on a scale | Standard Deviation 1.6 |
| Comfilcon A (2 Weeks) | Comfort During the Day | 4:00 pm | 8.74 units on a scale | Standard Deviation 1.31 |
| Lotrafilcon B (2 Weeks) | Comfort During the Day | 8:00 am | 8.67 units on a scale | Standard Deviation 1.21 |
| Lotrafilcon B (2 Weeks) | Comfort During the Day | 4:00 pm | 8.51 units on a scale | Standard Deviation 1.49 |
| Lotrafilcon B (2 Weeks) | Comfort During the Day | 8:00 pm | 7.91 units on a scale | Standard Deviation 1.89 |
| Lotrafilcon B (2 Weeks) | Comfort During the Day | 12:00 pm | 8.59 units on a scale | Standard Deviation 1.26 |
| Comfilcon A (4 Weeks) | Comfort During the Day | 4:00 pm | 8.70 units on a scale | Standard Deviation 1.45 |
| Comfilcon A (4 Weeks) | Comfort During the Day | 8:00 am | 8.96 units on a scale | Standard Deviation 1.26 |
| Comfilcon A (4 Weeks) | Comfort During the Day | 12:00 pm | 8.73 units on a scale | Standard Deviation 1.41 |
| Comfilcon A (4 Weeks) | Comfort During the Day | 8:00 pm | 8.25 units on a scale | Standard Deviation 1.77 |
| Lotrafilcon B (4 Weeks) | Comfort During the Day | 12:00 pm | 8.72 units on a scale | Standard Deviation 1.39 |
| Lotrafilcon B (4 Weeks) | Comfort During the Day | 4:00 pm | 8.31 units on a scale | Standard Deviation 1.56 |
| Lotrafilcon B (4 Weeks) | Comfort During the Day | 8:00 am | 8.78 units on a scale | Standard Deviation 1 |
| Lotrafilcon B (4 Weeks) | Comfort During the Day | 8:00 pm | 7.85 units on a scale | Standard Deviation 1.7 |
| Lotrafilcon B (Day 26) | Comfort During the Day | 12:00 pm | 8.60 units on a scale | Standard Deviation 1.32 |
| Lotrafilcon B (Day 26) | Comfort During the Day | 8:00 pm | 7.89 units on a scale | Standard Deviation 1.92 |
| Lotrafilcon B (Day 26) | Comfort During the Day | 4:00 pm | 8.27 units on a scale | Standard Deviation 1.62 |
| Lotrafilcon B (Day 26) | Comfort During the Day | 8:00 am | 8.59 units on a scale | Standard Deviation 1.48 |