Trial Outcomes & Findings for Quantification of the Visual Benefits of Soft Toric Contact Lenses Compared to Soft Spherical Contact Lenses (NCT NCT04613882)
NCT ID: NCT04613882
Last Updated: 2023-10-11
Results Overview
Visual acuity was assessed using logMAR for each intervention.
COMPLETED
NA
59 participants
Baseline with low contrast VA
2023-10-11
Participant Flow
59 participants were screened for eligibility. Two participants did not meet the inclusion criteria and therefore were not included in the randomization. Each of the 3 interventions were subdivided into 7 cylinder groups based on required astigmatism range. Of the remaining 57 participants, 4 participants were assigned to cylinder groups which were already full and thus they did not receive any of the interventions. The remaining 53 participants completed the study using the three interventions.
Unit of analysis: Eyes
Participant milestones
| Measure |
Spherical Contact Lens, Spectacle, Toric Contact Lens
Spherical CL for 30 minutes, then Spectacles for 30 minutes, then Toric CL for 30 minutes
|
Spherical Contact Lens, Toric Contact Lens, Spectacle
Spherical CL for 30 minutes, then Toric CL for 30 minutes, then Spectacles for 30 minutes
|
Spectacle, Spherical Contact Lens, Toric Contact Lens
Spectacles for 30 minutes, then Spherical CL for 30 minutes, then Toric CL for 30 minutes
|
Spectacles, Toric Contact Lens, Spherical Contact Lens
Spectacles for 30 minutes, then Toric CL for 30 minutes, then Spherical CL for 30 minutes
|
Toric Contact Lens, Spherical Contact Lens, Spectacles
Toric CL for 30 minutes, then Spherical CL for 30 minutes, then Spectacles for 30 minutes
|
Toric Contact Lens, Spectacles, Spherical Contact Lens
Toric CL for 30 minutes, then Spectacles for 30 minutes, then Spherical CL for 30 minutes
|
|---|---|---|---|---|---|---|
|
First Intervention
STARTED
|
14 23
|
6 9
|
9 15
|
5 6
|
6 9
|
13 22
|
|
First Intervention
COMPLETED
|
14 23
|
6 9
|
9 15
|
5 6
|
6 9
|
13 22
|
|
First Intervention
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Second Intervention
STARTED
|
14 23
|
6 9
|
9 15
|
5 6
|
6 9
|
13 22
|
|
Second Intervention
COMPLETED
|
14 23
|
6 9
|
9 15
|
5 6
|
6 9
|
13 22
|
|
Second Intervention
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Third Intervention
STARTED
|
14 23
|
6 9
|
9 15
|
5 6
|
6 9
|
13 22
|
|
Third Intervention
COMPLETED
|
14 23
|
6 9
|
9 15
|
5 6
|
6 9
|
13 22
|
|
Third Intervention
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Spherical Contact Lens, Spectacles, Toric Contact Lens
n=23 Eyes
Spherical CL for 30 minutes, then Spectacles for 30 minutes, then Toric CL for 30 minutes
|
Spherical Contact Lens, Toric Contact Lens, Spectacles
n=9 Eyes
Spherical CL for 30 minutes, then Toric CL for 30 minutes, then Spectacles for 30 minutes
|
Spectacles, Spherical Contact Lens, Toric Contact Lens
n=15 Eyes
Spectacles for 30 minutes, then Spherical CL for 30 minutes, then Toric CL for 30 minutes
|
Spectacles, Toric Contact Lens, Spherical Contact Lens
n=6 Eyes
Spectacles for 30 minutes, then Toric CL for 30 minutes, then Spherical CL for 30 minutes
|
Toric Contact Lens, Spherical Contact Lens, Spectacles
n=9 Eyes
Toric CL for 30 minutes, then Spherical CL for 30 minutes, then Spectacles for 30 minutes
|
Toric Contact Lens, Spectacles, Spherical Contact Lens
n=22 Eyes
Toric CL for 30 minutes, then Spectacles for 30 minutes, then Spherical CL for 30 minutes
|
Total
n=84 Eyes
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
26.1 years
STANDARD_DEVIATION 4.8 • n=23 Eyes
|
27.3 years
STANDARD_DEVIATION 5.6 • n=9 Eyes
|
25.9 years
STANDARD_DEVIATION 5.0 • n=15 Eyes
|
28.2 years
STANDARD_DEVIATION 7.7 • n=6 Eyes
|
25.4 years
STANDARD_DEVIATION 6.7 • n=9 Eyes
|
27.8 years
STANDARD_DEVIATION 6.3 • n=22 Eyes
|
26.5 years
STANDARD_DEVIATION 5.7 • n=84 Eyes
|
|
Sex: Female, Male
Female
|
14 Eyes
n=23 Eyes
|
5 Eyes
n=9 Eyes
|
13 Eyes
n=15 Eyes
|
6 Eyes
n=6 Eyes
|
3 Eyes
n=9 Eyes
|
17 Eyes
n=22 Eyes
|
58 Eyes
n=84 Eyes
|
|
Sex: Female, Male
Male
|
9 Eyes
n=23 Eyes
|
4 Eyes
n=9 Eyes
|
2 Eyes
n=15 Eyes
|
0 Eyes
n=6 Eyes
|
6 Eyes
n=9 Eyes
|
5 Eyes
n=22 Eyes
|
26 Eyes
n=84 Eyes
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Baseline with low contrast VAVisual acuity was assessed using logMAR for each intervention.
Outcome measures
| Measure |
Overall Participants
n=84 Eyes
Total participants who completed the study
|
Soft Toric Custom Made Contact Lenses
Participants wore a spherical contact lens, a custom-made toric contact lens, and a spectacle correction, each in a random sequence for 30 minutes. Each optical correction was worn in one eye only, with the other eye patched. Participants had either a single eye or both eyes evaluated.
|
Spectacle Correction
Participants wore a spherical contact lens, a custom-made toric contact lens, and a spectacle correction, each in a random sequence for 30 minutes. Each optical correction was worn in one eye only, with the other eye patched. Participants had either a single eye or both eyes evaluated.
|
|---|---|---|---|
|
Visual Acuity
|
0.2 logMAR
Standard Deviation 0.09
|
—
|
—
|
PRIMARY outcome
Timeframe: After 30 minutes of dispense (Low Contrast VA)Visual acuity was assessed using logMAR for each intervention.
Outcome measures
| Measure |
Overall Participants
n=84 Eyes
Total participants who completed the study
|
Soft Toric Custom Made Contact Lenses
n=84 Eyes
Participants wore a spherical contact lens, a custom-made toric contact lens, and a spectacle correction, each in a random sequence for 30 minutes. Each optical correction was worn in one eye only, with the other eye patched. Participants had either a single eye or both eyes evaluated.
|
Spectacle Correction
n=84 Eyes
Participants wore a spherical contact lens, a custom-made toric contact lens, and a spectacle correction, each in a random sequence for 30 minutes. Each optical correction was worn in one eye only, with the other eye patched. Participants had either a single eye or both eyes evaluated.
|
|---|---|---|---|
|
Visual Acuity
|
0.28 logMAR
Standard Deviation 0.013
|
0.24 logMAR
Standard Deviation 0.09
|
0.21 logMAR
Standard Deviation 0.09
|
PRIMARY outcome
Timeframe: Baseline with High contrast VAVisual acuity was assessed using logMAR for each intervention.
Outcome measures
| Measure |
Overall Participants
n=84 Eyes
Total participants who completed the study
|
Soft Toric Custom Made Contact Lenses
Participants wore a spherical contact lens, a custom-made toric contact lens, and a spectacle correction, each in a random sequence for 30 minutes. Each optical correction was worn in one eye only, with the other eye patched. Participants had either a single eye or both eyes evaluated.
|
Spectacle Correction
Participants wore a spherical contact lens, a custom-made toric contact lens, and a spectacle correction, each in a random sequence for 30 minutes. Each optical correction was worn in one eye only, with the other eye patched. Participants had either a single eye or both eyes evaluated.
|
|---|---|---|---|
|
Visual Acuity
|
-0.07 logMAR
Standard Deviation 0.07
|
—
|
—
|
PRIMARY outcome
Timeframe: After 30 minutes of dispense (High Contrast VA)Visual acuity was assessed using logMAR for each intervention.
Outcome measures
| Measure |
Overall Participants
n=84 Eyes
Total participants who completed the study
|
Soft Toric Custom Made Contact Lenses
n=84 Eyes
Participants wore a spherical contact lens, a custom-made toric contact lens, and a spectacle correction, each in a random sequence for 30 minutes. Each optical correction was worn in one eye only, with the other eye patched. Participants had either a single eye or both eyes evaluated.
|
Spectacle Correction
n=84 Eyes
Participants wore a spherical contact lens, a custom-made toric contact lens, and a spectacle correction, each in a random sequence for 30 minutes. Each optical correction was worn in one eye only, with the other eye patched. Participants had either a single eye or both eyes evaluated.
|
|---|---|---|---|
|
Visual Acuity
|
-0.02 logMAR
Standard Deviation 0.11
|
-0.08 logMAR
Standard Deviation 0.07
|
-0.1 logMAR
Standard Deviation 0.06
|
SECONDARY outcome
Timeframe: Entrance (Prior to wear of study lens)Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.
Outcome measures
| Measure |
Overall Participants
n=84 Eyes
Total participants who completed the study
|
Soft Toric Custom Made Contact Lenses
Participants wore a spherical contact lens, a custom-made toric contact lens, and a spectacle correction, each in a random sequence for 30 minutes. Each optical correction was worn in one eye only, with the other eye patched. Participants had either a single eye or both eyes evaluated.
|
Spectacle Correction
Participants wore a spherical contact lens, a custom-made toric contact lens, and a spectacle correction, each in a random sequence for 30 minutes. Each optical correction was worn in one eye only, with the other eye patched. Participants had either a single eye or both eyes evaluated.
|
|---|---|---|---|
|
Slit Lamp Biomicroscopy Findings - Conjunctival Redness
|
1.0 units on a scale
Standard Deviation 0.3
|
—
|
—
|
SECONDARY outcome
Timeframe: At Exit (After 30 minutes in each of three interventions)Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.
Outcome measures
| Measure |
Overall Participants
n=84 Eyes
Total participants who completed the study
|
Soft Toric Custom Made Contact Lenses
Participants wore a spherical contact lens, a custom-made toric contact lens, and a spectacle correction, each in a random sequence for 30 minutes. Each optical correction was worn in one eye only, with the other eye patched. Participants had either a single eye or both eyes evaluated.
|
Spectacle Correction
Participants wore a spherical contact lens, a custom-made toric contact lens, and a spectacle correction, each in a random sequence for 30 minutes. Each optical correction was worn in one eye only, with the other eye patched. Participants had either a single eye or both eyes evaluated.
|
|---|---|---|---|
|
Slit Lamp Biomicroscopy Findings - Conjunctival Redness
|
1.0 units on a scale
Standard Deviation 0.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Entrance (Prior to wear of study lens)Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.
Outcome measures
| Measure |
Overall Participants
n=84 Eyes
Total participants who completed the study
|
Soft Toric Custom Made Contact Lenses
Participants wore a spherical contact lens, a custom-made toric contact lens, and a spectacle correction, each in a random sequence for 30 minutes. Each optical correction was worn in one eye only, with the other eye patched. Participants had either a single eye or both eyes evaluated.
|
Spectacle Correction
Participants wore a spherical contact lens, a custom-made toric contact lens, and a spectacle correction, each in a random sequence for 30 minutes. Each optical correction was worn in one eye only, with the other eye patched. Participants had either a single eye or both eyes evaluated.
|
|---|---|---|---|
|
Slit Lamp Biomicroscopy Findings - Limbal Redness
|
0.9 units on a scale
Standard Deviation 0.3
|
—
|
—
|
SECONDARY outcome
Timeframe: At Exit (After 30 minutes in each of three interventions)Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.
Outcome measures
| Measure |
Overall Participants
n=84 Eyes
Total participants who completed the study
|
Soft Toric Custom Made Contact Lenses
Participants wore a spherical contact lens, a custom-made toric contact lens, and a spectacle correction, each in a random sequence for 30 minutes. Each optical correction was worn in one eye only, with the other eye patched. Participants had either a single eye or both eyes evaluated.
|
Spectacle Correction
Participants wore a spherical contact lens, a custom-made toric contact lens, and a spectacle correction, each in a random sequence for 30 minutes. Each optical correction was worn in one eye only, with the other eye patched. Participants had either a single eye or both eyes evaluated.
|
|---|---|---|---|
|
Slit Lamp Biomicroscopy Findings - Limbal Redness
|
0.9 units on a scale
Standard Deviation 0.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Entrance (Prior to wear of study lens)Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.
Outcome measures
| Measure |
Overall Participants
n=84 Eyes
Total participants who completed the study
|
Soft Toric Custom Made Contact Lenses
Participants wore a spherical contact lens, a custom-made toric contact lens, and a spectacle correction, each in a random sequence for 30 minutes. Each optical correction was worn in one eye only, with the other eye patched. Participants had either a single eye or both eyes evaluated.
|
Spectacle Correction
Participants wore a spherical contact lens, a custom-made toric contact lens, and a spectacle correction, each in a random sequence for 30 minutes. Each optical correction was worn in one eye only, with the other eye patched. Participants had either a single eye or both eyes evaluated.
|
|---|---|---|---|
|
Slit Lamp Biomicroscopy Findings - Corneal Staining
|
0.2 units on a scale
Standard Deviation 0.5
|
—
|
—
|
SECONDARY outcome
Timeframe: At Exit (After 30 minutes in each of three interventions)Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.
Outcome measures
| Measure |
Overall Participants
n=84 Eyes
Total participants who completed the study
|
Soft Toric Custom Made Contact Lenses
Participants wore a spherical contact lens, a custom-made toric contact lens, and a spectacle correction, each in a random sequence for 30 minutes. Each optical correction was worn in one eye only, with the other eye patched. Participants had either a single eye or both eyes evaluated.
|
Spectacle Correction
Participants wore a spherical contact lens, a custom-made toric contact lens, and a spectacle correction, each in a random sequence for 30 minutes. Each optical correction was worn in one eye only, with the other eye patched. Participants had either a single eye or both eyes evaluated.
|
|---|---|---|---|
|
Slit Lamp Biomicroscopy Findings - Corneal Staining
|
0.3 units on a scale
Standard Deviation 0.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Entrance (Prior to wear of study lens)Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.
Outcome measures
| Measure |
Overall Participants
n=84 Eyes
Total participants who completed the study
|
Soft Toric Custom Made Contact Lenses
Participants wore a spherical contact lens, a custom-made toric contact lens, and a spectacle correction, each in a random sequence for 30 minutes. Each optical correction was worn in one eye only, with the other eye patched. Participants had either a single eye or both eyes evaluated.
|
Spectacle Correction
Participants wore a spherical contact lens, a custom-made toric contact lens, and a spectacle correction, each in a random sequence for 30 minutes. Each optical correction was worn in one eye only, with the other eye patched. Participants had either a single eye or both eyes evaluated.
|
|---|---|---|---|
|
Slit Lamp Biomicroscopy Findings - Conjunctival Staining
|
0.4 units on a scale
Standard Deviation 0.4
|
—
|
—
|
SECONDARY outcome
Timeframe: At Exit (After 30 minutes in each of three interventions)Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.
Outcome measures
| Measure |
Overall Participants
n=84 Eyes
Total participants who completed the study
|
Soft Toric Custom Made Contact Lenses
Participants wore a spherical contact lens, a custom-made toric contact lens, and a spectacle correction, each in a random sequence for 30 minutes. Each optical correction was worn in one eye only, with the other eye patched. Participants had either a single eye or both eyes evaluated.
|
Spectacle Correction
Participants wore a spherical contact lens, a custom-made toric contact lens, and a spectacle correction, each in a random sequence for 30 minutes. Each optical correction was worn in one eye only, with the other eye patched. Participants had either a single eye or both eyes evaluated.
|
|---|---|---|---|
|
Slit Lamp Biomicroscopy Findings - Conjunctival Staining
|
0.6 units on a scale
Standard Deviation 0.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Entrance (Prior to wear of study lens)Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.
Outcome measures
| Measure |
Overall Participants
n=84 Eyes
Total participants who completed the study
|
Soft Toric Custom Made Contact Lenses
Participants wore a spherical contact lens, a custom-made toric contact lens, and a spectacle correction, each in a random sequence for 30 minutes. Each optical correction was worn in one eye only, with the other eye patched. Participants had either a single eye or both eyes evaluated.
|
Spectacle Correction
Participants wore a spherical contact lens, a custom-made toric contact lens, and a spectacle correction, each in a random sequence for 30 minutes. Each optical correction was worn in one eye only, with the other eye patched. Participants had either a single eye or both eyes evaluated.
|
|---|---|---|---|
|
Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis
|
1.1 units on a scale
Standard Deviation 0.3
|
—
|
—
|
SECONDARY outcome
Timeframe: At Exit (After 30 minutes in each of three interventions)Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.
Outcome measures
| Measure |
Overall Participants
n=84 Eyes
Total participants who completed the study
|
Soft Toric Custom Made Contact Lenses
Participants wore a spherical contact lens, a custom-made toric contact lens, and a spectacle correction, each in a random sequence for 30 minutes. Each optical correction was worn in one eye only, with the other eye patched. Participants had either a single eye or both eyes evaluated.
|
Spectacle Correction
Participants wore a spherical contact lens, a custom-made toric contact lens, and a spectacle correction, each in a random sequence for 30 minutes. Each optical correction was worn in one eye only, with the other eye patched. Participants had either a single eye or both eyes evaluated.
|
|---|---|---|---|
|
Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis
|
1.1 units on a scale
Standard Deviation 0.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Entrance (Prior to wear of study lens)Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.
Outcome measures
| Measure |
Overall Participants
n=84 Eyes
Total participants who completed the study
|
Soft Toric Custom Made Contact Lenses
Participants wore a spherical contact lens, a custom-made toric contact lens, and a spectacle correction, each in a random sequence for 30 minutes. Each optical correction was worn in one eye only, with the other eye patched. Participants had either a single eye or both eyes evaluated.
|
Spectacle Correction
Participants wore a spherical contact lens, a custom-made toric contact lens, and a spectacle correction, each in a random sequence for 30 minutes. Each optical correction was worn in one eye only, with the other eye patched. Participants had either a single eye or both eyes evaluated.
|
|---|---|---|---|
|
Slit Lamp Biomicroscopy Findings - Corneal Oedema
|
0.0 units on a scale
Standard Deviation 0.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At Exit (After 30 minutes in each of three interventions)Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.
Outcome measures
| Measure |
Overall Participants
n=84 Eyes
Total participants who completed the study
|
Soft Toric Custom Made Contact Lenses
Participants wore a spherical contact lens, a custom-made toric contact lens, and a spectacle correction, each in a random sequence for 30 minutes. Each optical correction was worn in one eye only, with the other eye patched. Participants had either a single eye or both eyes evaluated.
|
Spectacle Correction
Participants wore a spherical contact lens, a custom-made toric contact lens, and a spectacle correction, each in a random sequence for 30 minutes. Each optical correction was worn in one eye only, with the other eye patched. Participants had either a single eye or both eyes evaluated.
|
|---|---|---|---|
|
Slit Lamp Biomicroscopy Findings - Corneal Oedema
|
0.0 units on a scale
Standard Deviation 0.0
|
—
|
—
|
Adverse Events
Overall Study
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Overall Study
n=57 participants at risk
It is not possible to report the adverse Events per intervention as the measurements were taken prior to the first intervention and the following third intervention. Thus, the Adverse Events reporting have been combined. The eye twitch and migraine occurred after wearing all three interventions (Spectacles, Spherical Contact Lens and Toric Contact Lens) and thus these data cannot be subdivided. For the corneal scar and asymptomatic CIE these were observed on study but following wear of their habitual contact lenses and occurred prior to wear of the study interventions and thus these data cannot be further subdivided.
|
|---|---|
|
General disorders
Migraine
|
1.8%
1/57 • The data was collected in the time frame of 90 days
\[Not Specified\]
|
|
Eye disorders
Corneal Scar
|
1.8%
1/57 • The data was collected in the time frame of 90 days
\[Not Specified\]
|
|
Eye disorders
asymptomatic corneal infiltrate event
|
1.8%
1/57 • The data was collected in the time frame of 90 days
\[Not Specified\]
|
|
Eye disorders
Twitching in the eye
|
1.8%
1/57 • The data was collected in the time frame of 90 days
\[Not Specified\]
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place