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Trial Outcomes & Findings for Glaucoma Biomarkers (NCT NCT01677507)

NCT ID: NCT01677507

Last Updated: 2017-09-13

Results Overview

Eye pressure is a steady state quantitative trait that is measured in mm Hg. Eye pressure is determined by the following physiological factors (units of measure): eye fluid or aqueous humor production (microliters/minute), aqueous humor outflow (microliters/minute), outflow resistance (microliters/minute/mm Hg) and venous pressure (mm Hg) of the eye. All of these physiological factors will be determined under baseline condition and under glaucoma drug treatment.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

135 participants

Primary outcome timeframe

Measurement after 1 week of drug treatment

Results posted on

2017-09-13

Participant Flow

135 consented. Prior to baseline measures: 4 were excluded for ineligibility; 6 withdrew consent fully prior to baseline measurements. After baseline measures: an additional 2 were excluded based on physician decision, and 2 withdrew for participant decision. Thus, 121 participants are included for period 1.

Participant milestones

Participant milestones
Measure
Timolol Followed by Latanoprost
To compare the variation in response to timolol between individuals Variation in eye pressure response to timolol and latanoprost treatment: Arm 1 initial period is to test for variation in eye pressure response to timolol 0.5%, then washout. Period 2 is to test for variation in eye pressure response to latanoprost 0.005%.
Latanoprost Followed by Timolol
To compare the variation in response to latanoprost between individuals Variation in eye pressure response to timolol and latanoprost treatment: Arm 1 initial period is to test for variation in eye pressure response to latanoprost 0.005%, then washout. Period 2 is to test for variation in eye pressure response to timolol 0.5%.
Initial Assignment
STARTED
63
58
Initial Assignment
COMPLETED
63
56
Initial Assignment
NOT COMPLETED
0
2
Second Assigment
STARTED
63
56
Second Assigment
COMPLETED
60
51
Second Assigment
NOT COMPLETED
3
5

Reasons for withdrawal

Reasons for withdrawal
Measure
Timolol Followed by Latanoprost
To compare the variation in response to timolol between individuals Variation in eye pressure response to timolol and latanoprost treatment: Arm 1 initial period is to test for variation in eye pressure response to timolol 0.5%, then washout. Period 2 is to test for variation in eye pressure response to latanoprost 0.005%.
Latanoprost Followed by Timolol
To compare the variation in response to latanoprost between individuals Variation in eye pressure response to timolol and latanoprost treatment: Arm 1 initial period is to test for variation in eye pressure response to latanoprost 0.005%, then washout. Period 2 is to test for variation in eye pressure response to timolol 0.5%.
Initial Assignment
Adverse Event
0
1
Initial Assignment
Protocol Violation
0
1
Second Assigment
Withdrawal by Subject
2
2
Second Assigment
Adverse Event
1
3

Baseline Characteristics

There was missing aqueous flow data on 2 participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Baseline of Entire Population
n=125 Participants
Both arms are included because the study design was a cross over intent to treat with glaucoma medications. All participants were treated with both medications.
Age, Continuous
55.1 years
STANDARD_DEVIATION 8.8 • n=125 Participants
Sex: Female, Male
Female
94 Participants
n=125 Participants
Sex: Female, Male
Male
31 Participants
n=125 Participants
Race/Ethnicity, Customized
White
107 Participants
n=125 Participants
Race/Ethnicity, Customized
Asian
2 Participants
n=125 Participants
Race/Ethnicity, Customized
Hispanic
3 Participants
n=125 Participants
Race/Ethnicity, Customized
Black or African American
12 Participants
n=125 Participants
Race/Ethnicity, Customized
American Indian
1 Participants
n=125 Participants
Region of Enrollment
United States
125 participants
n=125 Participants
Intraocular pressure
Right eye
14.4 mmHg
STANDARD_DEVIATION 3.5 • n=125 Participants
Intraocular pressure
Left eye
13.9 mmHg
STANDARD_DEVIATION 3.5 • n=125 Participants
Aqueous humor flow
Right eye
3.1 microliters/min
STANDARD_DEVIATION 1.2 • n=123 Participants • There was missing aqueous flow data on 2 participants.
Aqueous humor flow
Left eye
2.9 microliters/min
STANDARD_DEVIATION 0.9 • n=123 Participants • There was missing aqueous flow data on 2 participants.
Episcleral venous pressure
Right eye
8.3 mmHg
STANDARD_DEVIATION 1.7 • n=96 Participants • One site used a different method to measure episcleral venous pressure (n=29)
Episcleral venous pressure
Left eye
7.9 mmHg
STANDARD_DEVIATION 1.5 • n=125 Participants • One site used a different method to measure episcleral venous pressure (n=29)

PRIMARY outcome

Timeframe: Measurement after 1 week of drug treatment

Eye pressure is a steady state quantitative trait that is measured in mm Hg. Eye pressure is determined by the following physiological factors (units of measure): eye fluid or aqueous humor production (microliters/minute), aqueous humor outflow (microliters/minute), outflow resistance (microliters/minute/mm Hg) and venous pressure (mm Hg) of the eye. All of these physiological factors will be determined under baseline condition and under glaucoma drug treatment.

Outcome measures

Outcome measures
Measure
Timolol
n=114 Participants
To characterize the response to timolol in all participants.
Latanoprost
n=116 Participants
To characterize the response to latanoprost in all participants.
Variation in Eye Pressure Between Individuals.
RIght Eyes
11.5 mmHg
Standard Deviation 3.2
11.3 mmHg
Standard Deviation 3.2
Variation in Eye Pressure Between Individuals.
Left Eyes
11.0 mmHg
Standard Deviation 3.0
11.0 mmHg
Standard Deviation 2.9

SECONDARY outcome

Timeframe: 1 week after treatment

Population: These measurements can be difficult for participants to tolerate, so sometimes values are missing.

Aqueous flow production (microliters/minute) will be determined under baseline condition and under glaucoma drug treatment.

Outcome measures

Outcome measures
Measure
Timolol
n=112 Participants
To characterize the response to timolol in all participants.
Latanoprost
n=114 Participants
To characterize the response to latanoprost in all participants.
Variation in Aqueous Flow Between Individuals.
Right eye
1.9 microliters/min
Standard Deviation 0.6
2.8 microliters/min
Standard Deviation 0.9
Variation in Aqueous Flow Between Individuals.
Left eye
2.0 microliters/min
Standard Deviation 0.6
3.0 microliters/min
Standard Deviation 1.0

SECONDARY outcome

Timeframe: 1 week treatment

Population: These measures can be difficult to obtain, so sometimes participants do not tolerate it and some values are missing.

Episcleral venous pressure (mm Hg) of the eye will be determined under baseline condition and under glaucoma drug treatment.

Outcome measures

Outcome measures
Measure
Timolol
n=110 Participants
To characterize the response to timolol in all participants.
Latanoprost
n=107 Participants
To characterize the response to latanoprost in all participants.
Variation in Episcleral Venous Pressure.
Right eye
7.6 mmHg
Standard Deviation 1.5
7.7 mmHg
Standard Deviation 1.9
Variation in Episcleral Venous Pressure.
Left eye
7.3 mmHg
Standard Deviation 1.5
7.4 mmHg
Standard Deviation 1.7

Adverse Events

Timolol

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Latanoprost

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

Dr. Sayoko Moroi

University of Michigan

Phone: 734-763-3732

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place