Trial Outcomes & Findings for Symptom Response in Normal and Dry Eye Patients Secondary to Application of a Menthol-Containing Eyedrop (Rohto® Hydra) (NCT NCT02985827)
NCT ID: NCT02985827
Last Updated: 2023-06-27
Results Overview
Participants completed the cooling scale after receiving 1 dose of Rohto (r) Hydra at 6 time points (0, 0.5, 1, 2, 3, and 4 minutes post-treatment), and the scores were summed across these time points. The cooling scale was on a scale of 0 to 10, where 0=not cool and 10=very cool. The summed total was on a scale of 0= not cool and 60=very cool.
COMPLETED
PHASE4
48 participants
4 Minutes
2023-06-27
Participant Flow
Participant milestones
| Measure |
Dry Eye Participants
Participants with dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto \[r\] Hydra) in one eye and 1 drop of comparator treatment (Systane \[r\] Ultra), which did not contain menthol, in the other.
|
Normal Participants
Participants who did not have dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto \[r\] Hydra) in one eye and 1 drop of comparator treatment (Systane \[r\] Ultra), which did not contain menthol, in the other.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
15
|
|
Overall Study
COMPLETED
|
33
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Symptom Response in Normal and Dry Eye Patients Secondary to Application of a Menthol-Containing Eyedrop (Rohto® Hydra)
Baseline characteristics by cohort
| Measure |
Dry Eye Participants
n=33 Participants
Participants with dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto \[r\] Hydra) in one eye and 1 drop of comparator treatment (Systane \[r\] Ultra), which did not contain menthol, in the other.
|
Normal Participants
n=15 Participants
Participants who did not have dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto \[r\] Hydra) in one eye and 1 drop of comparator treatment (Systane \[r\] Ultra), which did not contain menthol, in the other.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Age, Continuous
|
62.2 years
STANDARD_DEVIATION 8.6 • n=99 Participants
|
53.5 years
STANDARD_DEVIATION 7.6 • n=107 Participants
|
58.4 years
STANDARD_DEVIATION 9.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 4 MinutesPopulation: All Participants Population- all participants who received both study treatments.
Participants completed the cooling scale after receiving 1 dose of Rohto (r) Hydra at 6 time points (0, 0.5, 1, 2, 3, and 4 minutes post-treatment), and the scores were summed across these time points. The cooling scale was on a scale of 0 to 10, where 0=not cool and 10=very cool. The summed total was on a scale of 0= not cool and 60=very cool.
Outcome measures
| Measure |
Dry Eye Participants
n=33 Participants
Participants with dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto \[r\] Hydra) in one eye and 1 drop of comparator treatment (Systane \[r\] Ultra), which did not contain menthol, in the other.
|
Normal Participants
n=15 Participants
Participants who did not have dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto \[r\] Hydra) in one eye and 1 drop of comparator treatment (Systane \[r\] Ultra), which did not contain menthol, in the other.
|
|---|---|---|
|
Sum of the Cooling Scale For Rohto (r) Hydra
|
24.6 units on a scale
Standard Deviation 12.2
|
12.1 units on a scale
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: 4 minutesPopulation: All Participants Population- all participants who received both study treatments.
Participants completed the cooling scale after receiving 1 dose of Systane (r) Ultra at 6 time points (0, 0.5, 1, 2, 3, and 4 minutes post-treatment), and the scores were summed across these time points. The cooling scale was on a scale of 0 to 10, where 0=not cool and 10=very cool. The summed total was on a scale of 0= not cool and 60=very cool.
Outcome measures
| Measure |
Dry Eye Participants
n=33 Participants
Participants with dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto \[r\] Hydra) in one eye and 1 drop of comparator treatment (Systane \[r\] Ultra), which did not contain menthol, in the other.
|
Normal Participants
n=15 Participants
Participants who did not have dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto \[r\] Hydra) in one eye and 1 drop of comparator treatment (Systane \[r\] Ultra), which did not contain menthol, in the other.
|
|---|---|---|
|
Sum of the Cooling Scale For Systane (r) Ultra
|
12.6 units on a scale
Standard Deviation 9.4
|
5.2 units on a scale
Standard Deviation 6.1
|
Adverse Events
Dry Eye Participants
Normal Participants
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 restrictions are in place