Trial Outcomes & Findings for IOP Patterns in Ocular Hypertensive Patients Newly Converted to Glaucoma vs Stable Ocular Hypertensive Patients (NCT NCT02030886)

Results Overview

For each subject, TF acrophase (ie. time when peak occured) was scored dichotomously (before and after 7 am) and compared between OHT converters and non converters patients. One subject was removed from the analysis because of invalid TF output.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

24 hours

Results posted on

2020-10-20

Participant Flow

Participant milestones

Participant milestones
Measure	Ocular Hypertension Non Converters Stable ocular hypertension patients monitored by Triggerfish (TF) for 24 hours.	Ocular Hypertension Converters Ocular hypertension patients who progressed to glaucoma monitored by TF for 24 hours
Overall Study STARTED	14	6
Overall Study COMPLETED	14	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

IOP Patterns in Ocular Hypertensive Patients Newly Converted to Glaucoma vs Stable Ocular Hypertensive Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ocular Hypertension Non Converters n=14 Participants Stable ocular hypertension patients monitored by TF for 24 hours.	Ocular Hypertension Converters n=6 Participants Ocular hypertension patients who progressed to glaucoma monitored by TF for 24 hours.	Total n=20 Participants Total of all reporting groups
Age, Continuous	58.3 years STANDARD_DEVIATION 10.9 • n=5 Participants	59.3 years STANDARD_DEVIATION 6.7 • n=7 Participants	58.7 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	6 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: Stable ocular hypertension patients and ocular hypertension patients who progressed to glaucoma both monitored by TF for 24 hours. One subject was removed from the analysis because of invalid TF output.

For each subject, TF acrophase (ie. time when peak occured) was scored dichotomously (before and after 7 am) and compared between OHT converters and non converters patients. One subject was removed from the analysis because of invalid TF output.

Outcome measures

Outcome measures
Measure	Ocular Hypertension Non Converters n=13 Participants Stable ocular hypertension patients monitored by TF for 24 hours	Ocular Hypertension Converters n=6 Participants Ocular hypertension patients who progressed to glaucoma monitored by TF for 24 hours
Relationship Between Intraocular Pressure (IOP) Pattern as Recorded by TF, and Quantified by Acrophase Scored Dichotomously, and Conversion to Glaucoma in Ocular Hypertension (OHT) Patients (Conversion Status) Before 7 am	92.3 percentage of participants	66.7 percentage of participants
Relationship Between Intraocular Pressure (IOP) Pattern as Recorded by TF, and Quantified by Acrophase Scored Dichotomously, and Conversion to Glaucoma in Ocular Hypertension (OHT) Patients (Conversion Status) After 7 am	7.7 percentage of participants	33.3 percentage of participants

SECONDARY outcome

Timeframe: 24 hours

Population: Stable ocular hypertension patients and ocular hypertension patients who progressed to glaucoma both monitored by TF for 24 hours. One subject was removed from the analysis because of invalid TF output.

Mean TF acrophase (ie. actual time when peak occured) was compared between OHT converters and non converters. One subject was removed from the analysis because of invalid TF output.

Outcome measures

Outcome measures
Measure	Ocular Hypertension Non Converters n=13 Participants Stable ocular hypertension patients monitored by TF for 24 hours	Ocular Hypertension Converters n=6 Participants Ocular hypertension patients who progressed to glaucoma monitored by TF for 24 hours
Acrophase Scored Continuously (i.e. Actual Time of TF Peak Occurrence)	5.35 hour Standard Deviation 2.01	6.30 hour Standard Deviation 3.55

SECONDARY outcome

Timeframe: 24 hours

Population: Stable ocular hypertension patients and ocular hypertension patients who progressed to glaucoma, both monitored by TF for 24 hours. One subject was removed from the analysis because of invalid TF output.

This represents an estimate of the magnitude of 24-hour IOP-related variation. One subject was removed from the analysis because of invalid TF output.

Outcome measures

Outcome measures
Measure	Ocular Hypertension Non Converters n=13 Participants Stable ocular hypertension patients monitored by TF for 24 hours	Ocular Hypertension Converters n=6 Participants Ocular hypertension patients who progressed to glaucoma monitored by TF for 24 hours
Amplitude of Best-fitting Cosine Curve to 24-hour TF Measurements	126.9 mVEq Standard Deviation 52.6	128.0 mVEq Standard Deviation 49.5

Adverse Events

Ocular Hypertension Non Converters

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Ocular Hypertension Converters

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ocular Hypertension Non Converters n=13 participants at risk Stable ocular hypertension patients monitored by TF for 24 hours. One subject was removed from the analysis because of invalid TF output.	Ocular Hypertension Converters n=6 participants at risk Ocular hypertension patients who progressed to glaucoma monitored by TF for 24 hours
Eye disorders Upper lid swelling	7.7% 1/13 • Number of events 1 • Within the 24h recording	0.00% 0/6 • Within the 24h recording

Additional Information

Dr James Liu

Yale School of Medicine

Phone: +1 203 785 2020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place