Trial Outcomes & Findings for Clinical Evaluation of Two Toric Contact Lenses in Current Non-toric Lens Users (NCT NCT01180998)
NCT ID: NCT01180998
Last Updated: 2018-06-19
Results Overview
Percent of subjects with success with toric lens fitting defined as meeting all of the following pre-determined criteria: 1) acceptable fit, 2) orientation stability less than or equal to 20 degree rotation, 3) binocular visual acuity (VA) within one line of spectacle VA, 4) Good, very good, or excellent overall quality of Vision, and 5) good, very, good, or excellent overall lens comfort. There was not an inferential statistical analysis conducted on this outcome. Comparison was made through the use of 95% CI's for the proportions. Therefore no statistical analysis section is included for this primary outcome.
COMPLETED
NA
200 participants
4 weeks
2018-06-19
Participant Flow
Subjects were recruited and randomized to one of two parallel arms. Three categories of subjects were recruited: spherical soft lens wearers, CL drop-outs, neophytes.
The data from 10 subjects was disqualified from the analysis due to subjects' ineligibility being determined after enrollment.
Participant milestones
| Measure |
Spherical Contact Lens Users
Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.
|
Contact Lens Drop-outs
Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, used one of two toric lenses in a daily wear modality.
|
Habitual Correction With Spectacles (Neophytes)
Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
|
|---|---|---|---|
|
Overall Study
STARTED
|
67
|
72
|
61
|
|
Overall Study
COMPLETED
|
63
|
68
|
51
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
10
|
Reasons for withdrawal
| Measure |
Spherical Contact Lens Users
Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.
|
Contact Lens Drop-outs
Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, used one of two toric lenses in a daily wear modality.
|
Habitual Correction With Spectacles (Neophytes)
Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
|
|---|---|---|---|
|
Overall Study
Poor Vision
|
0
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Poor comfort
|
3
|
0
|
4
|
|
Overall Study
Poor lens handling
|
0
|
0
|
2
|
Baseline Characteristics
Clinical Evaluation of Two Toric Contact Lenses in Current Non-toric Lens Users
Baseline characteristics by cohort
| Measure |
Spherical Contact Lens Users
n=67 Participants
Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.
|
Contact Lens Drop-outs
n=72 Participants
Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, and used one of two toric lenses in a daily wear modality.
|
Habitual Correction With Spectacles (Neophytes)
n=61 Participants
Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
36.6 years
STANDARD_DEVIATION 11.8 • n=99 Participants
|
39.2 years
STANDARD_DEVIATION 10.0 • n=107 Participants
|
32.4 years
STANDARD_DEVIATION 12.3 • n=206 Participants
|
36.3 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
71 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
129 Participants
n=7 Participants
|
|
Region of Enrollment
United Kingdom
|
67 participants
n=99 Participants
|
72 participants
n=107 Participants
|
61 participants
n=206 Participants
|
200 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: All subjects that were dispensed a study lens except those that discontinued for non-clinical reasons.
Percent of subjects with success with toric lens fitting defined as meeting all of the following pre-determined criteria: 1) acceptable fit, 2) orientation stability less than or equal to 20 degree rotation, 3) binocular visual acuity (VA) within one line of spectacle VA, 4) Good, very good, or excellent overall quality of Vision, and 5) good, very, good, or excellent overall lens comfort. There was not an inferential statistical analysis conducted on this outcome. Comparison was made through the use of 95% CI's for the proportions. Therefore no statistical analysis section is included for this primary outcome.
Outcome measures
| Measure |
Spherical Contact Lens Users
n=66 Participants
Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.
|
Contact Lens Drop-outs
n=70 Participants
Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, and used one of two toric lenses in a daily wear modality.
|
Habitual Correction With Spectacles (Neophytes)
n=56 Participants
Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
|
|---|---|---|---|
|
Overall Success in Fitting With a Toric Contact Lens
|
80 percentage of participants
Interval 71.0 to 90.0
|
74 percentage of participants
Interval 64.0 to 85.0
|
70 percentage of participants
Interval 58.0 to 82.0
|
PRIMARY outcome
Timeframe: after 1 week of toric contact lens wearPopulation: All subjects that were dispensed a study lens except those that discontinued for non-clinical reasons.
Measured monocularly (each eye separately) in Snellen converted to logMAR units. The logMAR scale has a range of -0.30 to 1.00. A value of 0 or less would not require distance vision correction and a value of 0 or greater may require distance vision correction.
Outcome measures
| Measure |
Spherical Contact Lens Users
n=128 eyes
Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.
|
Contact Lens Drop-outs
n=136 eyes
Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, and used one of two toric lenses in a daily wear modality.
|
Habitual Correction With Spectacles (Neophytes)
n=102 eyes
Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
|
|---|---|---|---|
|
Distance Visual Acuity
1DAMfa Lens
|
-0.03 logMAR
Standard Error 0.01
|
0.01 logMAR
Standard Error 0.01
|
0.01 logMAR
Standard Error 0.01
|
|
Distance Visual Acuity
AofA Lens
|
-0.01 logMAR
Standard Error 0.01
|
0.05 logMAR
Standard Error 0.02
|
0.02 logMAR
Standard Error 0.02
|
|
Distance Visual Acuity
Total Monocular VA
|
-0.02 logMAR
Standard Error 0.01
|
0.02 logMAR
Standard Error 0.01
|
0.02 logMAR
Standard Error 0.01
|
PRIMARY outcome
Timeframe: after 4 weeks of toric contact lens wearPopulation: All subjects that were dispensed a study lens except those that discontinued for non-clinical reasons.
Visual Acuity is measured monocularly (each eye separately) in Snellen, the converted to logMAR units. The logMAR scale has a range of -0.30 to 1.00. A value of 0 or less would not require distance vision correction and a value of 0 or greater may require distance vision correction.
Outcome measures
| Measure |
Spherical Contact Lens Users
n=124 eyes
Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.
|
Contact Lens Drop-outs
n=132 eyes
Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, and used one of two toric lenses in a daily wear modality.
|
Habitual Correction With Spectacles (Neophytes)
n=94 eyes
Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
|
|---|---|---|---|
|
Distance Visual Acuity (VA)
1DAMfa Lens
|
-0.03 logMAR
Standard Error 0.01
|
0.01 logMAR
Standard Error 0.01
|
0.01 logMAR
Standard Error 0.01
|
|
Distance Visual Acuity (VA)
AOfA Lens
|
0.01 logMAR
Standard Error 0.01
|
0.04 logMAR
Standard Error 0.02
|
0.02 logMAR
Standard Error 0.02
|
|
Distance Visual Acuity (VA)
Total Monocular VA
|
-0.02 logMAR
Standard Error 0.01
|
0.02 logMAR
Standard Error 0.01
|
0.00 logMAR
Standard Error 0.01
|
Adverse Events
Spherical Contact Lens Users
Contact Lens Drop-outs
Habitual Correction With Spectacles (Neophytes)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication required agreement and written authorization from the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER