N/A
Completed N=77
Performance of Somofilcon A Over One Week in Wearers Adapted to Omafilcon A
Source: ClinicalTrials.gov NCT03226353 ↗Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcomePrimary: Investigator Opinion On Overall Patient Refit From Omafilcon A to Somofilcon A: Does Somofilcon A Provides Easy and Quick Refit From Omafilcon A? — 1; 0; 13; 11 Participants
Summary
The objective of the study is to determine if habitual or adapted contact lens wearers of Omafilcon A can be confidently refit into Somofilcon A lenses and be successful after one week of daily wear.
The primary outcome variables for this study are:
* Investigator responses to refit questions;
* Lens fit.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Investigator Opinion On Overall Patient Refit From Omafilcon A to Somofilcon A: Does Somofilcon A Provides Easy and Quick Refit From Omafilcon A? |
1; 0; 13; 11; 32; 12 | — |
| PRIMARY Investigator Assessment to Refit- Based on the Investigator Opinion and Lens Fit Outcomes, Would the Investigator Refit the Subject Into Somofilcon A From Omafilcon A? |
0; 2; 18; 20; 18; 11 | — |
| PRIMARY Investigator Assessment to Refit - Does Somofilcon A Performs Better Than Omafilcon A Day? |
1; 3; 30; 19; 14; 2 | — |
| PRIMARY Investigator Assessment to Refit - Does Somofilcon A Provides an Upgrade From Omafilcon A? |
1; 2; 19; 22; 19; 6 | — |
| PRIMARY Lens Fit - Post-blink Lens Movement |
2.1; 2.2; 1.9; 2.0 | — |
| PRIMARY Lens Fit - Lens Tightness |
48; 46; 51; 47 | — |
| PRIMARY Lens Fit - Lens Deposition |
0.38; 0.22; 0.60; 0.36 | — |
| PRIMARY Lens Fit - Centration |
26; 40; 43; 27; 0; 0 | — |
| PRIMARY Lens Fit - Lens Wettability |
0.54; 0.21; 0.83; 0.42 | — |
| PRIMARY Overall Lens Fit Acceptance |
3.3; 3.6; 3.2; 3.4 | — |
Eligibility Criteria
Inclusion Criteria
- Is at least 17 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Habitually wears soft spherical contact lenses with a power between +6.00 to -10.00D (inclusive) for a minimum 5 days per week, 10 hours per day and anticipates no difficulty wearing contact lenses for 7 days per week, 10 hours per day;
- Habitually wears, or is able to be adequately refit into Proclear 1 Day lenses;
- Demonstrates an acceptable fit with Proclear 1 Day and Clariti 1 Day contact lenses;
- Is correctable to a visual acuity of 0.20 LogMAR (approximately 20/30) or better (in each eye) with the study lenses or habitual correction;
- Manifest cylindrical spectacle refraction does not exceed -1.00DC in either eye.
Exclusion Criteria
- Is participating in any concurrent clinical research study;
- Has any known active* ocular disease and/or infection;
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal communication);
- Is aphakic;
- Has undergone refractive error surgery;
- Is an employee of the Centre for Contact Lens Research;
- Has taken part in another clinical or (pharmaceutical) research study within the last 7 days.
Data sourced from ClinicalTrials.gov (NCT03226353). 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.