Toric Mark visible or not visible. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
| Group | Value | 95% CI |
|---|---|---|
| Test Contact Lenses | 100 | |
| Control Contact Lenses | 100 |
| Group | Value | 95% CI |
|---|---|---|
| Test Contact Lenses | 0 | |
| Control Contact Lenses | 0 |
Last reviewed · How we verify
Clinical Evaluation of Invigor Toric 1-Day Contact Lenses
NA trial testing 1-day toric test contact lens in Astigmatism in 10 participants. Completed in 4 June 2019.
| Lead sponsor | CooperVision, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 6 May 2019 |
| Primary completion | 15 May 2019 |
| Estimated completion | 4 June 2019 |
| Sites | 1 location across United States |
CooperVision, Inc.
18 and older, any sex, with Astigmatism. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Toric Mark visible or not visible. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
| Group | Value | 95% CI |
|---|---|---|
| Test Contact Lenses | 100 | |
| Control Contact Lenses | 100 |
| Group | Value | 95% CI |
|---|---|---|
| Test Contact Lenses | 0 | |
| Control Contact Lenses | 0 |
Average of lens toric mark mislocation from the resting toric mark away from the 6 o'clock position - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
| Group | Value | 95% CI |
|---|---|---|
| Test Contact Lenses | 0 | ± 7 |
| Control Contact Lenses | -1 | ± 7 |
Average of lens toric mark mislocation from the resting toric mark away from the 6 o'clock position - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
| Group | Value | 95% CI |
|---|---|---|
| Test Contact Lenses | 1 | ± 6 |
| Control Contact Lenses | 0 | ± 7 |
Average of lens toric mark mislocation from the resting toric mark away from the 6 o'clock position - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
| Group | Value | 95% CI |
|---|---|---|
| Test Contact Lenses | -1 | ± 6 |
| Control Contact Lenses | -1 | ± 6 |
Toric stability (maximal and minimal differences between extreme gazes) measured in degrees for up, down, right, and left gazes. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
| Group | Value | 95% CI |
|---|---|---|
| Test Contact Lenses | 4 | ± 3 |
| Control Contact Lenses | 4 | ± 3 |
Rotational stability (maximal and minimal differences between extreme gazes) measured in degrees for up, down, right, and left gazes. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
| Group | Value | 95% CI |
|---|---|---|
| Test Contact Lenses | 5 | ± 3 |
| Control Contact Lenses | 4 | ± 3 |
Rotational Recovery for nasal and temporal - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
| Group | Value | 95% CI |
|---|---|---|
| Test Contact Lenses | 16 | ± 9 |
| Control Contact Lenses | 15 | ± 10 |
| Group | Value | 95% CI |
|---|---|---|
| Test Contact Lenses | 10 | ± 10 |
| Control Contact Lenses | 10 | ± 9 |
Rotational Recovery for nasal and temporal - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
| Group | Value | 95% CI |
|---|---|---|
| Test Contact Lenses | 16 | ± 9 |
| Control Contact Lenses | 12 | ± 10 |
| Group | Value | 95% CI |
|---|---|---|
| Test Contact Lenses | 9 | ± 10 |
| Control Contact Lenses | 10 | ± 10 |
Toric fit acceptance and preference scale 0-4 (0 = can't be worn, 4 = optimum). Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
| Group | Value | 95% CI |
|---|---|---|
| Test Contact Lenses | 3.5 | ± 0.2 |
| Control Contact Lens | 3.4 | ± 0.2 |
Toric fit acceptance and preference scale 0-4 (0 = can't be worn, 4 = optimum). Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
| Group | Value | 95% CI |
|---|---|---|
| Test Contact Lenses | 3.5 | ± 0.2 |
| Control Contact Lenses | 3.4 | ± 0.3 |
Investigator's toric fitting preference - Test lens , No Preference , Control lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
| Group | Value | 95% CI |
|---|---|---|
| Overall Study | 23 |
| Group | Value | 95% CI |
|---|---|---|
| Overall Study | 69 |
| Group | Value | 95% CI |
|---|---|---|
| Overall Study | 8 |
Investigator's toric fitting preference - Test lens, No Preference, Control lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
| Group | Value | 95% CI |
|---|---|---|
| Overall Study | 33 |
| Group | Value | 95% CI |
|---|---|---|
| Overall Study | 57 |
| Group | Value | 95% CI |
|---|---|---|
| Overall Study | 10 |
An evaluation of the clinical performance of the 1-day toric test contact lens compared to the 1-day toric control contact lens over one hour of lens wear.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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