N/A
Completed N=50
Comparative Study of Two Marketed 1-day Soft Contact Lenses
Source: ClinicalTrials.gov NCT01464255 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcomePrimary: Lens Fit - Decentration After Insertion — 0.12; 0.07; -0.11; -0.15 mm
Summary
This study is designed to evaluate ocufilcon D lens compared to ocufilcon B lens in a 1-week crossover, daily wear regimen.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lens Fit - Decentration After Insertion |
0.12; 0.07; -0.11; -0.15 | — |
| PRIMARY Lens Fit - Decentration at One Week |
0.14; 0.09; -0.08; -0.18 | — |
| PRIMARY Lens Fit - Tightness After Insertion |
50.0; 52.4 | — |
| PRIMARY Lens Fit - Tightness at One Week |
42.4; 46 | — |
| PRIMARY Lens Fit - Post-Blink Lens Movement After Insertion |
0.29; 0.3 | — |
| PRIMARY Lens Fit - Post-Blink Lens Movement Prior to Removal |
0.38; 0.48 | — |
| SECONDARY Overall Preference - Comfort After Insertion |
43; 21; 18; 16; 2 | — |
| SECONDARY Overall Preference - Comfort Before Removal |
29; 29; 18; 20; 4 | — |
| SECONDARY Overall Preference - Dryness After Insertion |
23; 12; 55; 10; 0 | — |
| SECONDARY Overall Preference - Dryness Before Removal |
33; 22; 25; 18; 2 | — |
| SECONDARY Overall Preference - Handling, Inserting |
18; 23; 47; 8; 4 | — |
| SECONDARY Overall Preference - Handling, Removing |
8; 16; 74; 2; 0 | — |
| SECONDARY Overall Lens Pair Preference |
43; 22; 2; 29; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Has had a self reported oculo-visual examination in the last two years.
- Is able to wear the study lenses for at least eight hours a day, seven days a week
- Aged 18-40 years and has full legal capacity as a volunteer
- Has a distance contact lens prescription from -0.25 and -6.00D inclusive
- Has spectacle astigmatism of < 1.00D in each eye
- Baseline vision of 20/20 best-corrected in each eye.
- Is correctable to at least 20/25 distance visual acuity with study contact lenses in each eye
- Has read and understood the consent form and willing to sign consent form
- Willing and able to follow participant instructions and attend the required study visits Has worn soft contact lenses for at least two weeks prior to the study (daily wear only).
Exclusion Criteria
- Currently wears contact lenses on an extended wear basis.
- Not a current or past wearer of the ocufilcon B 52% 1-day lenses.
- Has undergone anterior ocular surgery
- Is aphakic
- Has never worn contact lenses before
- Has any systemic disease which clinically contraindicates contact lenses
- Has active ocular disease or severe insufficiency of lacrimal secretion (dry eye)
- Use of systemic or topical medications that will affect ocular health or visual performance
- Slit lamp findings with a grading of greater than 1.0 using the grading scales in Appendix 3
- Not possible to achieve a satisfactory fit with the lens design used in the study
- Has keratoconus or other corneal irregularity
- Participating in another eye-related clinical trial
- Pregnant, lactating or planning a pregnancy
Data sourced from ClinicalTrials.gov (NCT01464255). 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.