Astigmatism
Conditions
Brief summary
The purpose of this study was to investigate the overall clinical comfort performance of enfilcon A (test) lens and senofilcon A (control) lens over 15-minutes of lens wear.
Detailed description
This was a non-dispensing, single-masked, randomized, contralateral study comparing Enfilcon A (test) against Senofilcon A (control). Each subject was randomized to wear the test lens in one eye and the control lens in the other eye.
Interventions
DEVICEenfilcon A
Test lens
DEVICEsenofilcon A
Control lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 38 Years
Healthy volunteers
Yes
Inclusion criteria
1. Based on his/her knowledge, must be in good general health. 2. Be 18 to 38 years old. 3. Be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluation. 4. Read, indicate understanding of, and sign Written Informed Consent. 5. Be existing or successfully adapted users of soft contact lenses, but not currently wearing either of the study lenses (Avaira or Oasys) being evaluated in this trial. 6. Require a visual correction in both eyes. 7. Require a prescription between +8.00D and -12.00D and have less than or equal to 0.75D of astigmatism in both eyes. 8. Achieve visual acuity of 20/25 or better in each eye with a spherical contact lens prescription. 9. Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: * No amblyopia. * No evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes). * lamp findings Grade 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection). * No other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea \[infiltrates\], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology). * No aphakia.
Exclusion criteria
1. 0.75D or greater of refractive astigmatism in either eye. 2. Presbyopic or current monovision contact lens wear. 3. Cannot be currently wearing either lenses (Avaira or Oasys). 4. Presence of clinically significant (grade 2-4) anterior segment abnormalities; inflammation such as iritis; or any infection of the eye, lids, or associated structures. 5. Presence of ocular or systemic disease or need of medication which might interfere with contact lens wear. 6. Slit lamp findings that would contraindicate contact lens wear such as: * Pathological dry eye or associated findings * Pterygium, pinguecula or corneal scars within the visual axis * Neovascularization \> 0.75 mm in from the limbus * Giant papillary conjunctivitis (GPC) worse than Grade 1 * Anterior uveitis or iritis (past or present) * Seborrheic eczema, seborrheic conjunctivitis * History of corneal ulcer or fungal infections * Poor personal hygiene * A known history of corneal hypoesthesia (reduced corneal sensitivity) 7. Contact Lens best corrected Snellen visual acuities (VA) worse than 20/30. 8. Aphakia, Keratoconus or a highly irregular cornea.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort at Insertion | Baseline | Participant's response for comfort at insertion. (Scale 0-10; 0=poor/intolerable, 10=comfortable/ cannot be felt) Obtained at baseline. |
| Comfort Preference | Baseline | Participant's response for comfort preference of enfilcon A (test) lens, senofilcon A(control) lens at insertion. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Group participants randomized to wear the (enfilcon A) test lens in one eye and the senofilcon A (control) in the other eye. | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Overall Study Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants |
| Region of Enrollment United States | 60 participants |
| Sex: Female, Male Female | 43 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Comfort at Insertion
Participant's response for comfort at insertion. (Scale 0-10; 0=poor/intolerable, 10=comfortable/ cannot be felt) Obtained at baseline.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enfilcon A | Comfort at Insertion | 8.7 units on a scale | Standard Deviation 1.6 |
| Senofilcon A | Comfort at Insertion | 8.5 units on a scale | Standard Deviation 1.7 |
Primary
Comfort at Insertion
Participant's response for comfort at 15 minutes. (Scale 0-10; 0=poor/intolerable, 10=comfortable/ cannot be felt) Obtained at 15 minutes.
Time frame: 15 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enfilcon A | Comfort at Insertion | 8.1 units on a scale | Standard Deviation 1.8 |
| Senofilcon A | Comfort at Insertion | 8.7 units on a scale | Standard Deviation 1.3 |
Primary
Comfort Preference
Participant's response for comfort preference of enfilcon A (test) lens, senofilcon A(control) lens at insertion.
Time frame: Baseline
Population: n=59, one participant would not choose a preference at the initial insertion as both lenses were the same to them.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enfilcon A | Comfort Preference | Prefer Senofilcon A | 29 participants |
| Enfilcon A | Comfort Preference | Prefer Enfilcon A | 30 participants |
Primary
Comfort Preference
Participant's response for comfort of enfilcon A (test) lens, senofilcon A (control) lens at 15 minutes wear.
Time frame: 15 minutes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enfilcon A | Comfort Preference | Preferred Senofilcon A | 35 participants |
| Enfilcon A | Comfort Preference | Preferred Enfilcon A | 25 participants |