Trial Outcomes & Findings for A Study of Quantitative Assessments of Angle Width in Chinese Patients With Open-angle Glaucoma and/or Ocular Hypertension (NCT NCT01781962)
NCT ID: NCT01781962
Last Updated: 2014-07-31
Results Overview
The angle width formed between the eye's cornea and iris in both eyes was measured in microns (µm) using AS OCT, a laser-based, noninvasive, diagnostic system providing high-resolution images of the eye.
TERMINATED
206 participants
Day 1
2014-07-31
Participant Flow
Participant milestones
| Measure |
All Participants
Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
|
|---|---|
|
Overall Study
STARTED
|
206
|
|
Overall Study
COMPLETED
|
201
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
All Participants
Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
|
|---|---|
|
Overall Study
Other Miscellaneous Reasons
|
5
|
Baseline Characteristics
A Study of Quantitative Assessments of Angle Width in Chinese Patients With Open-angle Glaucoma and/or Ocular Hypertension
Baseline characteristics by cohort
| Measure |
All Participants
n=206 Participants
Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
|
|---|---|
|
Age, Customized
<45 years
|
111 Participants
n=5 Participants
|
|
Age, Customized
45 to 65 years
|
71 Participants
n=5 Participants
|
|
Age, Customized
>65 years
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
115 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Participants from the Modified Intent-to-treat (mITT) population, all enrolled patients with both gonioscopy and AS OCT measurements, with evaluable data for this outcome measure.
The angle width formed between the eye's cornea and iris in both eyes was measured in microns (µm) using AS OCT, a laser-based, noninvasive, diagnostic system providing high-resolution images of the eye.
Outcome measures
| Measure |
All Participants
n=330 Eyes
Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
|
|---|---|
|
Anterior Angle Width Using Anterior Segment Optical Coherence Tomography (AS OCT)
|
638.8 µm
Standard Deviation 272.67
|
SECONDARY outcome
Timeframe: Day 1Population: Participants from the mITT population, all enrolled patients with both gonioscopy and AS OCT measurements, with data available for this outcome measure.
The angle width formed between the cornea and iris in both eyes was measured by gonioscopy using Shaffer grading where: grade 4=wide open, grade 3=moderately open, grade 2=moderately narrow, grade 1=very narrow or grade 0=closed. The number of eyes in each Shaffer Grade is reported.
Outcome measures
| Measure |
All Participants
n=405 Eyes
Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
|
|---|---|
|
Number of Study Eyes in Each Shaffer Grade Using Gonioscopic Lens
Grade 1
|
1 eye
NA
|
|
Number of Study Eyes in Each Shaffer Grade Using Gonioscopic Lens
Grade 2
|
1 eye
NA
|
|
Number of Study Eyes in Each Shaffer Grade Using Gonioscopic Lens
Grade 3
|
34 eye
334.86
|
|
Number of Study Eyes in Each Shaffer Grade Using Gonioscopic Lens
Grade 4
|
369 eye
262.33
|
SECONDARY outcome
Timeframe: Day 1Population: Participants from the mITT population, all enrolled patients with both gonioscopy and AS OCT measurements, with data available for this outcome measure.
The angle width formed between the cornea and iris in both eyes was measured by gonioscopy using Large Step Grading ranging from 1.0 (smallest angle width) to 7.5 (largest angle width) with 0.5 unit intervals where each Large Step unit represented a fixed length of approximately 200 µm. The number of eyes in each Large Step Grade is reported.
Outcome measures
| Measure |
All Participants
n=405 Eyes
Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
|
|---|---|
|
Number of Study Eyes in Each Step Grade Using Gonioscopic Lens
Step Grade 1.0
|
0 eye
126.92
|
|
Number of Study Eyes in Each Step Grade Using Gonioscopic Lens
Step Grade 1.5
|
4 eye
203.66
|
|
Number of Study Eyes in Each Step Grade Using Gonioscopic Lens
Step Grade 2.0
|
36 eye
206.72
|
|
Number of Study Eyes in Each Step Grade Using Gonioscopic Lens
Step Grade 2.5
|
32 eye
212.36
|
|
Number of Study Eyes in Each Step Grade Using Gonioscopic Lens
Step Grade 3.0
|
78 eye
191.87
|
|
Number of Study Eyes in Each Step Grade Using Gonioscopic Lens
Step Grade 3.5
|
24 eye
234.94
|
|
Number of Study Eyes in Each Step Grade Using Gonioscopic Lens
Step Grade 4.0
|
69 eye
290.20
|
|
Number of Study Eyes in Each Step Grade Using Gonioscopic Lens
Step Grade 4.5
|
23 eye
208.44
|
|
Number of Study Eyes in Each Step Grade Using Gonioscopic Lens
Step Grade 5.0
|
34 eye
119.57
|
|
Number of Study Eyes in Each Step Grade Using Gonioscopic Lens
Step Grade 5.5
|
9 eye
221.46
|
|
Number of Study Eyes in Each Step Grade Using Gonioscopic Lens
Step Grade 6.0
|
33 eye
184.16
|
|
Number of Study Eyes in Each Step Grade Using Gonioscopic Lens
Step Grade 6.5
|
28 eye
294.97
|
|
Number of Study Eyes in Each Step Grade Using Gonioscopic Lens
Step Grade 7.0
|
28 eye
158.44
|
|
Number of Study Eyes in Each Step Grade Using Gonioscopic Lens
Step Grade 7.5
|
7 eye
|
Adverse Events
All Participants
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 A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is at least 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER