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

• Sponsor: Sensimed AG (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02030886
• Collaborator: Yale University (Other)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 18
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

The purpose of the study is to assess the relationship between IOP pattern as recorded over 24 hours by using Triggerfish and quantified by acrophase scored dichotomously, and conversion to glaucoma in OHT patients (conversion status). Elevation of IOP above normal range is called "ocular hypertension" (OHT). In a previous study, it has been shown that OHT patients who progress to glaucoma (converters) have at baseline and prior to any conversion, IOP patterns that more closely resemble those of established early primary open-angle glaucoma (POAG) patients, while stable OHT patients (non-converters) have IOP patterns closer to those of healthy control subjects. The study has been planned to recruit at least 48 eligible patients (24 converters and 24 non-converters).

Condition or Disease	Intervention/Treatment	Phase
Ocular Hypertension	Device: Sensimed Triggersfish® (TF)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Single-center, Open Label, Prospective Study Assessing the 24-hour IOP Patterns Using SENSIMED Triggerfish® in Ocular Hypertensive Patients Newly Converted to Glaucomatous Disease Versus Stable Ocular Hypertensive Patients
• Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Ocular hypertension subjects All subjects will be monitored by Sensimed Triggerfish (TF) for 24 hours.	Device: Sensimed Triggersfish® (TF); All subjects will be monitored by Sensimed Triggerfish (TF) for 24 hours.

Outcome Measures

Primary Outcome Measures

1. 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) [24 hours]

   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.

Secondary Outcome Measures

1. Acrophase Scored Continuously (i.e. Actual Time of TF Peak Occurrence) [24 hours]

   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.

2. Amplitude of Best-fitting Cosine Curve to 24-hour TF Measurements [24 hours]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of OHT (IOP >21 mmHg on 2 consecutive visits) in the study eye

• No IOP-lowering drug treatment in the study eye; otherwise, a 4-week wash-out period prior to study day 0 (SD0) and throughout the study

• Aged ≥ 18 years, of either sex

• Not more than 6 diopters spherical equivalent in the study eye

• Having given written informed consent, prior to any investigational procedures

Exclusion Criteria:

• Narrow iridocorneal angle or any other concomitant ocular conditions (except cataract) in the study eye

• History of ocular surgery on the study eye (except cataract extraction)

• History of laser treatment on the study eye

• Corneal or conjunctival abnormality in the study eye, precluding contact lens adaptation

• Severe dry eye syndrome

• Subjects with irregular sleep schedules

• Subjects who are current smokers

• Subjects with allergy to corneal anesthetic

• Subjects with contraindications for silicone contact lens wear

• Subjects not able to understand the character and individual consequences of the investigation

• Participation in other clinical research within the last 4 weeks

• Any other contra-indication listed in the TF user manual

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale Medical School	New Haven	Connecticut	United States	06510

Sponsors and Collaborators

• Sensimed AG
• Yale University

Investigators

• Principal Investigator: Ji Liu, MD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sensimed AG
• ClinicalTrials.gov Identifier: NCT02030886
• Other Study ID Numbers: TF-1302
• First Posted: Jan 9, 2014
• Last Update Posted: Oct 20, 2020
• Last Verified: Sep 1, 2020

• Additional relevant MeSH terms: Ocular Hypertension

Study Results

Participant Flow

Arm/Group Title	Ocular Hypertension Non Converters	Ocular Hypertension Converters
Arm/Group Description	Stable ocular hypertension patients monitored by Triggerfish (TF) for 24 hours.	Ocular hypertension patients who progressed to glaucoma monitored by TF for 24 hours
Period Title: Overall Study
STARTED	14	6
COMPLETED	14	6
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Ocular Hypertension Non Converters	Ocular Hypertension Converters	Total
Arm/Group Description	Stable ocular hypertension patients monitored by TF for 24 hours.	Ocular hypertension patients who progressed to glaucoma monitored by TF for 24 hours.	Total of all reporting groups
Overall Participants	14	6	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.3 (10.9)	59.3 (6.7)	58.7 (9.7)
Sex: Female, Male (Count of Participants)
Female	7 50%	2 33.3%	9 45%
Male	7 50%	4 66.7%	11 55%
Region of Enrollment (participants) [Number]
United States	14 100%	6 100%	20 100%

Outcome Measures

1. Primary Outcome

Title	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)
Description	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.
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Ocular Hypertension Non Converters	Ocular Hypertension Converters
Arm/Group Description	Stable ocular hypertension patients monitored by TF for 24 hours	Ocular hypertension patients who progressed to glaucoma monitored by TF for 24 hours
Measure Participants	13	6
Before 7 am	92.3 659.3%	66.7 1111.7%
After 7 am	7.7 55%	33.3 555%

2. Secondary Outcome

Title	Acrophase Scored Continuously (i.e. Actual Time of TF Peak Occurrence)
Description	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.
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Ocular Hypertension Non Converters	Ocular Hypertension Converters
Arm/Group Description	Stable ocular hypertension patients monitored by TF for 24 hours	Ocular hypertension patients who progressed to glaucoma monitored by TF for 24 hours
Measure Participants	13	6
Mean (Standard Deviation) [hour]	5.35 (2.01)	6.30 (3.55)

3. Secondary Outcome

Title	Amplitude of Best-fitting Cosine Curve to 24-hour TF Measurements
Description	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.
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Ocular Hypertension Non Converters	Ocular Hypertension Converters
Arm/Group Description	Stable ocular hypertension patients	Ocular hypertension patients who progressed to glaucoma
Measure Participants	13	6
Mean (Standard Deviation) [mVEq]	126.9 (52.6)	128.0 (49.5)

Adverse Events

Time Frame	Within the 24h recording
Arm/Group Title	Ocular Hypertension Non Converters		Ocular Hypertension Converters
Arm/Group Description	Stable ocular hypertension patients monitored by TF for 24 hours. One subject was removed from the analysis because of invalid TF output.		Ocular hypertension patients who progressed to glaucoma monitored by TF for 24 hours
All Cause Mortality
	Ocular Hypertension Non Converters		Ocular Hypertension Converters
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/6 (0%)
Serious Adverse Events
	Ocular Hypertension Non Converters		Ocular Hypertension Converters
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	Ocular Hypertension Non Converters		Ocular Hypertension Converters
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/13 (7.7%)		0/6 (0%)
Eye disorders
Upper lid swelling	1/13 (7.7%)	1	0/6 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.