N/A
N=28
A Clinical Evaluation of Two Contact Lenses Used With Three Care Systems
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT04195581 ↗Enrolled (actual)
28
Serious AEs
1.2%
Results posted
Jun 2021
Primary outcome: Primary: Overall Comfort — 86.0; 81.6; 81.0; 87.7 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- comfilcon A (Device); fanfilcon A (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Comfort |
86.0; 81.6; 81.0; 87.7; 88.0; 82.7 | — |
| PRIMARY Comfort on Insertion |
88.3; 85.8; 84.0; 88.6; 90.3; 87.3 | — |
| PRIMARY Comfort Before Removal |
80.0; 72.8; 74.2; 79.1; 82.4; 76.1 | — |
| SECONDARY Vision |
94.8; 91.4; 93.3; 90.9; 94.2; 93.4 | — |
| SECONDARY Variable Vision |
92.5; 92.0; 91.8; 89.8; 92.8; 92.8 | — |
| SECONDARY Vision at Night |
92.5; 89.4; 91.6; 89.8; 91.3; 91.4 | — |
| SECONDARY Dryness |
85.5; 81.4; 81.5; 86.6; 86.3; 83.3 | — |
| SECONDARY Ocular Redness |
96.2; 92.6; 94.2; 95.8; 96.0; 92.7 | — |
| SECONDARY Burning/Stinging |
93.4; 90.6; 85.7; 92.4; 95.7; 89.6 | — |
| SECONDARY Ease of Lens Insertion |
93.5; 91.2; 91.7; 91.6; 92.9; 91.3 | — |
| SECONDARY Ease of Lens Removal |
92.1; 92.2; 91.6; 90.9; 92.0; 89.7 | — |
Summary
The objective of the study was to compare the clinical performance of the two contact lenses when used in combination with three care systems.
Eligibility Criteria
Inclusion Criteria
- They are aged 18-50 and have capacity to volunteer.
- They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
- They are willing and able to follow the protocol.
- They are an existing wearer of reusable, single vision, spherical soft contact lenses.
- They have a contact lens spherical prescription between -1.00 to - 6.50D (inclusive)
- They have a spectacle cylindrical correction of -1.00D or less in each eye.
- At dispensing, they can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
- They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
- They agree not to participate in other clinical research for the duration of the study.
Exclusion Criteria
- They have an ocular disorder which would normally contra-indicate contact lens wear.
- They have a systemic disorder which would normally contra-indicate contact lens wear.
- They are using any topical medication such as eye drops or ointment.
- They have had cataract surgery.
- They have had corneal refractive surgery.
- They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
- They are pregnant or breastfeeding.
- They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
- They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
- They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
Data sourced from ClinicalTrials.gov (NCT04195581). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.