N/A
Completed N=49
Comparison of Comfilcon A Toric Contact Lenses and Samfilcon A Toric Contact Lenses
Astigmatism
Source: ClinicalTrials.gov NCT03519932 ↗
Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcomePrimary: Comfort at Insertion — 9.0; 8.8 units on a scale
Summary
The objective of this study is to evaluate the subjective acceptance of comfilcon A toric contact lens, compared to samfilcon A toric lens.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comfort at Insertion |
9.0; 8.8 | — |
| PRIMARY Comfort |
8.1; 7.4; 7.1; 6.7 | — |
| PRIMARY Lens Preference Based on Overall Comfort |
44; 27; 7; 7; 16 | — |
| PRIMARY Lens Preference Based on Overall Dryness |
29; 33; 16; 4; 18 | — |
| PRIMARY Dryness |
7.5; 6.7; 6.6; 6.2 | — |
| SECONDARY Ease of Insertion |
9.0; 8.3 | — |
| SECONDARY Ease of Removal |
8.0; 8.5 | — |
Eligibility Criteria
Inclusion Criteria
- Is at least 17 years of age and has full legal capacity to volunteer;
- Has had a self-reported oculo-visual examination in the last two years.
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Is an adapted soft contact lens wearer, who currently wears contact lenses for a minimum 3 days/week and 8 hours/day AND who anticipates no difficulty wearing CLs for 6 days/week, 10 hours /day.
- Is willing to wear contact lens in both eyes for the duration of the study;
- Has a minimum astigmatism of - 0.75, determined by refraction;
- Can be fit with the two study contact lens types in the powers available;
- Has a distance visual acuity of 0.20 logMAR (approx 20/30) or better, determined by refraction;
- Can achieve a distance visual acuity of 0.20 logMAR (approx 20/30) or better in each eye with the study contact lenses.
- Has clear corneas and no active* ocular disease
Exclusion Criteria
- Is participating in any concurrent clinical trial;
- Has any known active* ocular disease and/or infection;
- Has a systemic condition that in the opinion of the investigator may affect a study measure;
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure;
- Has known sensitivity to fluorescein dye or products to be used in the study;
- Appears to have any active* ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses;
- Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
- Is aphakic;
- Has undergone refractive error surgery.
- Has participated in the PIANO (i.e. EX-MKTG-83) Study.
Data sourced from ClinicalTrials.gov (NCT03519932). 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. Informational only — not medical advice.