N/A
Completed N=63
A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over 1 Month of Daily Wear
Source: ClinicalTrials.gov NCT01952665 ↗Enrolled (actual)
63
Serious AEs
0.8%
Results posted
Sep 2015
Primary outcomePrimary: Comfort at Insertion — 9.21; 8.22 units on a scale
Summary
A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over 1 Month of Daily Wear
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comfort at Insertion |
9.21; 8.22 | — |
| PRIMARY Visual Quality |
9.27; 8.87 | — |
| PRIMARY Average Daily Wearing Time |
13.57; 13.91 | — |
| PRIMARY Comfortable Wearing Time |
11.07; 10.67 | — |
| PRIMARY Comfort |
8.70; 8.12; 8.29; 7.77; 7.38; 6.58 | — |
| PRIMARY Dryness |
8.34; 7.70; 7.38; 6.74; 8.04; 7.39 | — |
| PRIMARY Handling |
9.21; 9.25; 9.27; 9.25 | — |
| PRIMARY Vision Satisfaction |
9.13; 8.51 | — |
| PRIMARY Eye Whiteness/Redness |
8.93; 8.53 | — |
| PRIMARY Overall Sensation of Moistness |
17; 13; 25; 21; 9; 14 | — |
| PRIMARY Overall Sensation of Smoothness |
22; 18; 23; 16; 8; 16 | — |
| PRIMARY Overall Comfort Satisfaction |
28; 20; 21; 25; 5; 8 | — |
| PRIMARY Overall Dryness Satisfaction |
22; 21; 27; 22; 5; 8 | — |
| PRIMARY Overall Handling Satisfaction |
42; 44; 12; 11; 1; 2 | — |
| PRIMARY Overall Vision Satisfaction |
45; 38; 8; 12; 2; 3 | — |
| PRIMARY Overall Satisfaction |
28; 23; 22; 23; 5; 9 | — |
| PRIMARY Lens Preference, Pair 1 Comfilcon A |
26; 32; 26; 32; 29; 29 | — |
| PRIMARY Lens Preference, Pair 1 Lotrafilcon B |
19; 38; 18; 39; 25; 32 | — |
| PRIMARY Rewetting Drops |
46; 48; 10; 9 | — |
| PRIMARY Lens Preference |
32; 21; 32; 21; 30; 23 | — |
| PRIMARY Lens Preference Comfort, Dryness, Vision and Overall. |
24; 10; 19; 23; 11; 19 | — |
| PRIMARY Lens Preference for Handling |
21; 14; 19 | — |
| SECONDARY Binocular Visual Acuity logMAR |
-0.052; -0.047 | — |
| SECONDARY Surface Wetting |
7.09; 6.95 | — |
| SECONDARY Surface Deposition |
0.58; 1.04 | — |
| SECONDARY Centration |
100; 106; 10; 8 | — |
| SECONDARY Corneal Coverage |
110; 114; 0; 0 | — |
| SECONDARY Post Blink Movement |
0; 0; 8; 11; 96; 92 | — |
| SECONDARY Push Up Test |
51.73; 52.24 | — |
| SECONDARY Overall Fit Acceptance |
0; 0; 0; 0; 6; 4 | — |
| SECONDARY Rewetting Drops |
46; 48; 10; 9 | — |
| SECONDARY Likelihood of Switching From Habitual Lens to Study Lens |
10; 9; 22; 9; 13; 16 | — |
| SECONDARY Likelihood to Continue Wearing the Study Lens |
13; 6; 23; 13; 10; 19 | — |
| SECONDARY Participant Recommendation of a Study Lens |
31; 22 | — |
| SECONDARY Participant Likelihood of Recommendation of a Study Lens |
6; 12; 6; 11; 19; 16 | — |
Eligibility Criteria
Inclusion Criteria
- Is between 18 and 40 years of age (inclusive)
- Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study
- Has had a self-reported visual exam in the last two years
- Is an adapted soft CL wearer
- Has a Contact Lens (CL) spherical prescription between - 1.00 and - 9.00 (inclusive)
- Has less than 0.75D spectacle cylinder in each eye
- Is correctable to a visual acuity of 20/25 or better in both eyes
- Has clear corneas and no active ocular disease
- Has read, understood and signed the information consent letter
- Is willing to comply with the wear schedule (at least 40 hrs per week)
- Is willing to comply with the visit schedule
Exclusion Criteria
- Has never worn contact lenses before
- Currently wears rigid gas permeable contact lenses
- Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
- Has a contact lens prescription outside the range of - 1.00 to -9.00D
- Has a spectacle cylinder greater than -0.50D of cylinder in either eye
- Has best corrected spectacle distance vision worse then 20/25 in either eye
- Has any systemic disease affecting ocular health
- Is using any systemic or topical medications that will affect ocular health
- Has any ocular pathology or severe insufficiency of lacrimal secretion
- Has persistent, clinically significant corneal or conjunctival staining
- Has active neovascularization or any central corneal scars
- Is aphakic
- Is presbyopic
- Has undergone corneal refractive surgery
- Is participating in any other type of eye related clinical or research study
Data sourced from ClinicalTrials.gov (NCT01952665). 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.