Trial Outcomes & Findings for Evaluation of On-eye Optical Performances of the RMY-100 Lens (NCT NCT03670277)
NCT ID: NCT03670277
Last Updated: 2025-04-25
Results Overview
Spherical aberration (Z4, 0) for a 5-mm pupil was measured by an aberrometer (COAS by AMO) with a distant viewing target at 4 m at the Baseline and post lens fitting. The Control Group only had 1 study Visit that record Baseline measurements, no intervention from the sponsor was implemented for this group, therefore data was collected on a bare eye. The Test group was fitted with the study lens at Visit 2 and data was collected with the Test lens on eye.
COMPLETED
NA
28 participants
Up to Post Lens Fitting Evaluation
2025-04-25
Participant Flow
A total of 28 subjects were enrolled into this study at 1 clinical site. Of those enrolled, 20 subjects in the test arm were dispensed a study lens while, 8 subjects in the control arm were not dispensed, all 28 subjects who were enrolled have completed the study.
Participant milestones
| Measure |
Test
Subjects were fit with the Test lens at Visit 2 of the study
|
Control
Existing Orthokeratology patients who have \>=5 mm pupil size at Visit 1 Baseline.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
8
|
|
Overall Study
COMPLETED
|
20
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of On-eye Optical Performances of the RMY-100 Lens
Baseline characteristics by cohort
| Measure |
Test
n=20 Participants
Subjects were fit with the Test lens at Visit 2 of the study
|
Control
n=8 Participants
Existing Orthokeratology patients who have \>=5 mm pupil size at Visit 1 Baseline.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
17.9 years
STANDARD_DEVIATION 3.82 • n=5 Participants
|
16.8 years
STANDARD_DEVIATION 4.62 • n=7 Participants
|
17.6 years
STANDARD_DEVIATION 4.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
10 participants
n=5 Participants
|
0 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
20 participants
n=5 Participants
|
8 participants
n=7 Participants
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Post Lens Fitting EvaluationPopulation: All subjects who were administered any test article excluding subjects who dropped out prior to administering any test article. At least one observation was recorded.
Spherical aberration (Z4, 0) for a 5-mm pupil was measured by an aberrometer (COAS by AMO) with a distant viewing target at 4 m at the Baseline and post lens fitting. The Control Group only had 1 study Visit that record Baseline measurements, no intervention from the sponsor was implemented for this group, therefore data was collected on a bare eye. The Test group was fitted with the study lens at Visit 2 and data was collected with the Test lens on eye.
Outcome measures
| Measure |
Test
n=17 Eyes
Subjects were fit with the Test lens at Visit 2 of the study
|
Control
n=7 Eyes
Existing Orthokeratology patients at Visit 1 Baseline
|
|---|---|---|
|
Distance Spherical Aberration (Z4, 0)
|
0.350 micron
Standard Deviation 0.066
|
0.364 micron
Standard Deviation 0.212
|
PRIMARY outcome
Timeframe: Up to Post Lens Fitting EvaluationPopulation: All subjects who were administered any test article excluding subjects who dropped out prior to administering any test article. At least one observation was recorded.
Spherical aberration (Z4, 0) for a 5 mm pupil was measured by an aberrometer (COAS by AMO) with a near view target at 25 cm. at the Baseline and post lens fitting. The Control Group only had 1 study Visit that record Baseline measurements, no intervention from the sponsor was implemented for this group, therefore data was collected on a bare eye. The Test group was fitted with the study lens at Visit 2 and data was collected with the Test lens on eye.
Outcome measures
| Measure |
Test
n=17 Eyes
Subjects were fit with the Test lens at Visit 2 of the study
|
Control
n=7 Eyes
Existing Orthokeratology patients at Visit 1 Baseline
|
|---|---|---|
|
Near Spherical Aberration (Z4, 0)
|
0.300 micron
Standard Deviation 0.061
|
0.272 micron
Standard Deviation 0.144
|
SECONDARY outcome
Timeframe: Up to Post Lens Fitting EvaluationPopulation: All subjects who were administered any test article excluding subjects who dropped out prior to administering any test article. At least one observation was recorded.
Distance off-axis refractions were measured by an open-field autorefractor (WAM-5500 by Grand Seiko) with distant viewing targets at 4 m and ±10°, ±20°, and ±30° off axis. at the Baseline and post lens fitting. The Control Group only had 1 study Visit that record Baseline measurements, no intervention from the sponsor was implemented for this group, therefore data was collected on a bare eye. The Test group was fitted with the study lens at Visit 2 and data was collected with the Test lens on eye.
Outcome measures
| Measure |
Test
n=20 Eyes
Subjects were fit with the Test lens at Visit 2 of the study
|
Control
n=8 Eyes
Existing Orthokeratology patients at Visit 1 Baseline
|
|---|---|---|
|
Distance Off-axis Refraction at ±10°, ±20°, and ±30° Retinal Eccentricities.
-30
|
0.3502 Diopter
Standard Deviation 3.79171
|
-3.0756 Diopter
Standard Deviation 1.66232
|
|
Distance Off-axis Refraction at ±10°, ±20°, and ±30° Retinal Eccentricities.
-20
|
-1.1344 Diopter
Standard Deviation 1.39215
|
-2.4579 Diopter
Standard Deviation 1.91260
|
|
Distance Off-axis Refraction at ±10°, ±20°, and ±30° Retinal Eccentricities.
-10
|
-0.3786 Diopter
Standard Deviation 0.94009
|
-0.4444 Diopter
Standard Deviation 0.53691
|
|
Distance Off-axis Refraction at ±10°, ±20°, and ±30° Retinal Eccentricities.
+10
|
-1.4402 Diopter
Standard Deviation 1.22240
|
-1.7429 Diopter
Standard Deviation 1.16422
|
|
Distance Off-axis Refraction at ±10°, ±20°, and ±30° Retinal Eccentricities.
+20
|
-1.9654 Diopter
Standard Deviation 1.22837
|
-4.4656 Diopter
Standard Deviation 2.07377
|
|
Distance Off-axis Refraction at ±10°, ±20°, and ±30° Retinal Eccentricities.
+30
|
-0.1098 Diopter
Standard Deviation 3.76589
|
-2.5638 Diopter
Standard Deviation 2.61755
|
SECONDARY outcome
Timeframe: Up to Post Lens Fitting EvaluationPopulation: All subjects who were administered any test article excluding subjects who dropped out prior to administering any test article. At least one observation was recorded.
Near off-axis refractions were measured by an open-field autorefractor (WAM-5500 by Grand Seiko) with near viewing targets at 25 cm and ±30° off-axis. at the Baseline and post lens fitting. The Control Group only had 1 study Visit that record Baseline measurements, no intervention from the sponsor was implemented for this group, therefore data was collected on a bare eye. The Test group was fitted with the study lens at Visit 2 and data was collected with the Test lens on eye.
Outcome measures
| Measure |
Test
n=20 Eyes
Subjects were fit with the Test lens at Visit 2 of the study
|
Control
n=8 Eyes
Existing Orthokeratology patients at Visit 1 Baseline
|
|---|---|---|
|
Near Off-axis Refraction at ±30° Retinal Eccentricities.
-30
|
-2.3463 Diopter
Standard Deviation 3.13560
|
-5.3558 Diopter
Standard Deviation 2.49516
|
|
Near Off-axis Refraction at ±30° Retinal Eccentricities.
+30
|
-3.6046 Diopter
Standard Deviation 3.37323
|
-4.9883 Diopter
Standard Deviation 3.77839
|
Adverse Events
Test
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Xu Cheng, MD, PhD, FAAO - Sr. Principal Clinical Scientist
Johnson & Johnson Vision Care
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60