Trial Outcomes & Findings for Clinical Performance of Existing Wearers of Avaira Sphere Following a Refit With Clariti Elite Sphere (NCT NCT02248727)
NCT ID: NCT02248727
Last Updated: 2020-07-28
Results Overview
Monocular and binocular logMAR visual acuity for enfilcon A / somofilcon A assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Baseline, 1 Week, 2 Week, 4 Week
Results posted on
2020-07-28
Participant Flow
Participant milestones
| Measure |
Enfilcon A / Somofilcon A
All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Performance of Existing Wearers of Avaira Sphere Following a Refit With Clariti Elite Sphere
Baseline characteristics by cohort
| Measure |
Enfilcon A / Somofilcon A
n=30 Participants
All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens
somofilcon A: All participants wear habitual enfilcon A lens first then refitted with somofilcon A lens
|
|---|---|
|
Age, Continuous
|
22.10 years
STANDARD_DEVIATION 2.02 • n=93 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
|
Region of Enrollment
Spain
|
30 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 Week, 2 Week, 4 WeekMonocular and binocular logMAR visual acuity for enfilcon A / somofilcon A assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week.
Outcome measures
| Measure |
Somofilcon A at 2 Week
n=30 Participants
All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
|
Somofilcon A at 4 Week
n=30 Participants
All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
|
Enfilcon A
n=30 Participants
All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
|
Somofilcon A at 1 Week
n=30 Participants
All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
|
|---|---|---|---|---|
|
Visual Acuity - Enfilcon A and Somofilcon A
Binocular
|
-0.067 logMar
Standard Deviation 0.066
|
-0.067 logMar
Standard Deviation 0.066
|
-0.067 logMar
Standard Deviation 0.066
|
-0.067 logMar
Standard Deviation 0.066
|
|
Visual Acuity - Enfilcon A and Somofilcon A
OD
|
-0.037 logMar
Standard Deviation 0.049
|
-0.037 logMar
Standard Deviation 0.049
|
-0.037 logMar
Standard Deviation 0.049
|
-0.037 logMar
Standard Deviation 0.049
|
|
Visual Acuity - Enfilcon A and Somofilcon A
OS
|
-0.037 logMar
Standard Deviation 0.049
|
-0.037 logMar
Standard Deviation 0.049
|
-0.037 logMar
Standard Deviation 0.049
|
-0.037 logMar
Standard Deviation 0.049
|
PRIMARY outcome
Timeframe: Baseline, 1 Week, 2 Week, 4 WeekSubjective assessments for: comfort, dryness, handling, overall vision satisfaction, and eye whiteness. Enfilcon A was assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week. Scale(s): comfort (0=very poor; 10=excellent), dryness (0=very dry; 10=no dryness), handling (0=very difficult; 10=very easy), overall vision satisfaction (0=very unsatisfied; 10=very satisfied), habitual eye whiteness (0=not white; 10= totally white)
Outcome measures
| Measure |
Somofilcon A at 2 Week
n=30 Participants
All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
|
Somofilcon A at 4 Week
n=30 Participants
All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
|
Enfilcon A
n=30 Participants
All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
|
Somofilcon A at 1 Week
n=30 Participants
All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
|
|---|---|---|---|---|
|
Subjective Assessments. - Enfilcon A and Somofilcon A
Comfort prior to removal
|
6.90 units on a scale
Standard Deviation 1.03
|
6.50 units on a scale
Standard Deviation 0.94
|
8.53 units on a scale
Standard Deviation 0.73
|
7.20 units on a scale
Standard Deviation 1.16
|
|
Subjective Assessments. - Enfilcon A and Somofilcon A
Overall comfort
|
7.07 units on a scale
Standard Deviation 0.98
|
6.60 units on a scale
Standard Deviation 0.93
|
8.47 units on a scale
Standard Deviation 0.82
|
7.40 units on a scale
Standard Deviation 0.97
|
|
Subjective Assessments. - Enfilcon A and Somofilcon A
Dryness prior to removal
|
7.27 units on a scale
Standard Deviation 1.05
|
6.80 units on a scale
Standard Deviation 1.16
|
8.47 units on a scale
Standard Deviation 0.86
|
7.77 units on a scale
Standard Deviation 1.04
|
|
Subjective Assessments. - Enfilcon A and Somofilcon A
Overall dryness
|
7.13 units on a scale
Standard Deviation 0.97
|
6.77 units on a scale
Standard Deviation 1.14
|
8.40 units on a scale
Standard Deviation 0.89
|
7.43 units on a scale
Standard Deviation 1.07
|
|
Subjective Assessments. - Enfilcon A and Somofilcon A
Handling
|
7.07 units on a scale
Standard Deviation 0.94
|
6.40 units on a scale
Standard Deviation 0.93
|
8.50 units on a scale
Standard Deviation 0.68
|
7.70 units on a scale
Standard Deviation 1.15
|
|
Subjective Assessments. - Enfilcon A and Somofilcon A
Overall vision satifaction
|
8.10 units on a scale
Standard Deviation 0.92
|
7.53 units on a scale
Standard Deviation 0.78
|
8.47 units on a scale
Standard Deviation 0.78
|
8.37 units on a scale
Standard Deviation 0.81
|
|
Subjective Assessments. - Enfilcon A and Somofilcon A
Habitual eye whiteness
|
8.17 units on a scale
Standard Deviation 0.87
|
7.73 units on a scale
Standard Deviation 0.83
|
8.40 units on a scale
Standard Deviation 0.81
|
8.23 units on a scale
Standard Deviation 0.73
|
|
Subjective Assessments. - Enfilcon A and Somofilcon A
Comfort on insertion
|
7.33 units on a scale
Standard Deviation 0.76
|
6.80 units on a scale
Standard Deviation 0.81
|
8.43 units on a scale
Standard Deviation 0.77
|
7.73 units on a scale
Standard Deviation 0.83
|
|
Subjective Assessments. - Enfilcon A and Somofilcon A
Dryness during the day
|
7.63 units on a scale
Standard Deviation 1.07
|
6.97 units on a scale
Standard Deviation 1.07
|
8.33 units on a scale
Standard Deviation 0.84
|
8.17 units on a scale
Standard Deviation 0.95
|
Adverse Events
Enfilcon A to Somofilcon A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Robert Montes-Mico, O.D., PhD
Optometry Research Group (GIO) University of Valencia
Phone: 34-9635-44764
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators are NOT employed by the organization sponsoring the study. There is an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.
- Publication restrictions are in place
Restriction type: OTHER