Trial Outcomes & Findings for Intraocular Pressure in Ocular Hypertensives With Scleral Lens Wear (NCT NCT04442464)
NCT ID: NCT04442464
Last Updated: 2024-04-29
Results Overview
Intraocular pressure measured in millimeters of mercury (mm Hg)
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
1 participants
Primary outcome timeframe
4 hours
Results posted on
2024-04-29
Participant Flow
Unit of analysis: Eye
Participant milestones
| Measure |
Study Eye
One eye will be randomly selected to wear the scleral lenses to be worn during study measurements
Scleral Lens: 15.0 mm diagnostic spherical rigid contact lens
|
Control Eye
Non-lens wearing eye
|
|---|---|---|
|
Overall Study
STARTED
|
1 1
|
1 1
|
|
Overall Study
COMPLETED
|
1 1
|
1 1
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intraocular Pressure in Ocular Hypertensives With Scleral Lens Wear
Baseline characteristics by cohort
| Measure |
All Study Participants
n=1 Participants
All participants had one eye randomly selected to wear the scleral lenses during study measurements and the other eye served as the control, non-lens wearing eye.
Scleral Lens: 15.0 mm diagnostic spherical rigid contact lens
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 hoursIntraocular pressure measured in millimeters of mercury (mm Hg)
Outcome measures
| Measure |
Study Eye
n=1 Eye
One eye will be randomly selected to wear the scleral lenses to be worn during study measurements
Scleral Lens: 15.0 mm diagnostic spherical rigid contact lens
|
Control Eye
n=1 Eye
Non-lens wearing eye
|
|---|---|---|
|
Intraocular Pressure (IOP)
Baseline
|
24.0 mmHg
|
23.5 mmHg
|
|
Intraocular Pressure (IOP)
4 hours
|
21.2 mmHg
|
21.5 mmHg
|
Adverse Events
Study Eye
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Eye
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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