Trial Outcomes & Findings for The Water Drinking Test in Glaucoma Study (NCT NCT05283031)

Results Overview

Maximum intraocular pressure difference between two methods applied to each subject (modified diurnal tension curve mDTC and water drinking test WDT). The difference between maximum intraocular pressure of five eye pressure measurements taken at 8:00, 10:00, 12:00, 14:00 and 16:00 minus the maximum intraocular pressure measured at 15 minute intervals over 45 minutes during the water drinking test.

Recruitment status

COMPLETED

Target enrollment

46 participants

Primary outcome timeframe

Single measurement (mDCT 5 measurements taken one every 2 hours and WDT a measurement taken every 15 minutes up to 45 minutes)

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	Glaucoma Patients Those included in the study were male or female participants between the ages of 18 to 80 years old with a diagnosis of POAG or NTG in either eye.
Overall Study STARTED	46
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Glaucoma Patients n=42 Participants Those included in the study were male or female participants between the ages of 18 to 80 years old with a diagnosis of POAG or NTG in either eye.
Age, Continuous	65.5 years STANDARD_DEVIATION 9.04 • n=42 Participants
Sex: Female, Male Female	22 Participants n=42 Participants
Sex: Female, Male Male	20 Participants n=42 Participants
Region of Enrollment United Kingdom	42 participants n=42 Participants
Mean baseline IOP (± SD)	14.9 mmHg STANDARD_DEVIATION 4.5 • n=42 Participants
Mean visual field mean deviation	-5.05 dB STANDARD_DEVIATION 5.45 • n=42 Participants

PRIMARY outcome

Timeframe: Single measurement (mDCT 5 measurements taken one every 2 hours and WDT a measurement taken every 15 minutes up to 45 minutes)

Maximum intraocular pressure difference between two methods applied to each subject (modified diurnal tension curve mDTC and water drinking test WDT). The difference between maximum intraocular pressure of five eye pressure measurements taken at 8:00, 10:00, 12:00, 14:00 and 16:00 minus the maximum intraocular pressure measured at 15 minute intervals over 45 minutes during the water drinking test.

Outcome measures

Outcome measures
Measure	Glaucoma Patients n=42 Participants Those included in the study were male or female participants between the ages of 18 to 80 years old with a diagnosis of POAG or NTG in either eye.
Maximum Intraocular Pressure Difference (Between mDCT and WDT)	-0.82 mmHg Standard Deviation 2.06

Adverse Events

Glaucoma Patients

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

Jamie Spofforth

Imperial College Ophthalmology Research Group

Phone: 020 3312 6666

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place