Astigmatism, Presbyopia
Conditions
Brief summary
This study aims to compare the short-term clinical performance of the two study contact lenses.
Detailed description
The aim of this study is to evaluate the short-term clinical performance of two multifocal toric soft contact lenses after 15 minutes of daily wear each.
Interventions
DEVICELens A (omafilcon A)
15 minutes of daily wear.
DEVICELens B (comfilcon A)
15 minutes of daily wear.
Sponsors
CooperVision, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. They are aged 35 years or over and have capacity to volunteer. 2. They understand their rights as a subject and are willing to sign a Statement of Informed Consent. 3. They are willing and able to follow the protocol. 4. They agree not to participate in other clinical research for the duration of this study. 5. They are currently wearing soft contact lenses or have done so within the past 12 months. 6. They have a spherical prescription between +10.00 and -10.00DS inclusive, (based on the ocular refraction). 7. They have astigmatism of between -0.75 and -5.75DC (based on the ocular refraction) in each eye. 8. They have a reading addition component to their spectacle refraction of between +0.75 and +2.50DS. 9. They can be satisfactorily fitted with the study lenses. 10. They own a wearable pair of spectacles.
Exclusion criteria
1. They have an ocular disorder which would normally contraindicate contact lens wear. 2. They have a systemic disorder which would normally contra-indicate contact lens wear. 3. They are using any topical medications such as eye drops or ointment. 4. They have had cataract surgery. 5. They have had corneal refractive surgery. 6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. 7. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear. 8. They have eye or health conditions including immunosuppressive or infectious diseases which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction. 9. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Distance Vision | At the end of 15 minutes of daily wear | Subjective Distance Vision will be measured on a scale from 0-100 (Where 0= Extremely poor. Intolerable. Lenses cannot be worn. 100= Excellent. Unaware of any visual loss). |
Countries
United Kingdom
Participant flow
Pre-assignment details
Forty participants were screened. Of those, four participants were ineligible and excluded from the study. Thirty-six participants were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Includes all enrolled participants | 36 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1: Lens A (15 Minutes) | Use of eye drops between study visits | 1 | 0 |
| Period 1: Lens A (15 Minutes) | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Continuous | 53.7 years STANDARD_DEVIATION 8.3 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 23 Participants | — |
| Sex: Female, Male Male | 13 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 34 | 0 / 36 |
| other Total, other adverse events | 0 / 36 | 0 / 34 | 2 / 36 |
| serious Total, serious adverse events | 0 / 36 | 0 / 34 | 0 / 36 |
Outcome results
Primary
Subjective Distance Vision
Subjective Distance Vision will be measured on a scale from 0-100 (Where 0= Extremely poor. Intolerable. Lenses cannot be worn. 100= Excellent. Unaware of any visual loss).
Time frame: At the end of 15 minutes of daily wear
Population: All participants that completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lens A (Omafilcon A) | Subjective Distance Vision | 77.1 units on a scale | Standard Deviation 19.6 |
| Lens B (Comfilcon A) | Subjective Distance Vision | 80.0 units on a scale | Standard Deviation 14.5 |