Extraction form for project: Screening for Glaucoma in Adults - 1 of 2

Design Details

1. Study design

Arms

Arm NameArm Description
A. Netarsudil/Latanaprost FDCP (n=238; comparison NR)
B. Netarsudil 0.02% (n=244)
C. Latanaprost 0.005% (n=236)

Sample Characteristics

1. N
A. Netarsudil/Latanaprost FDCP (n=238; comparison NR)
B. Netarsudil 0.02% (n=244)
C. Latanaprost 0.005% (n=236)
Total
2. Baseline population
A. Netarsudil/Latanaprost FDCP (n=238; comparison NR)
B. Netarsudil 0.02% (n=244)
C. Latanaprost 0.005% (n=236)
Total

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalVision disorderMean intraocular pressure (IOP) reduction >20%
  • All Participants
  • end of study
CategoricalVision disorderIntraocular pressure (IOP), percent change from baseline
  • All Participants
  • end of study
ContinuousHarm/adverse eventWithdrawal due to adverse events
  • All Participants
  • end of study
ContinuousHarm/adverse eventSerious adverse events, none considered related to treatment
  • All Participants
  • end of study

Risk of Bias Assessment

1. Random assignment
2. Allocation concealed
3. Groups similar at baseline
4. Eligibility criteria specified
5. Blinding: outcome assessors or data analysts
6. Intention-to-treat analysis
7. Reporting of attrition, contamination, etc.
8. Differential loss to followup or overall high loss to followup
9. Appropriate analysis including cluster correlation
10. Funding source
11. Randomization adequate?
12. Allocation concealment adequate?
13. Groups similar at baseline?
14. Eligibility criteria specified?
15. Outcome assessors masked?
16. Care provider masked?
17. Patient masked?
18. Attrition and withdrawals reported?
19. Loss to followup differential/ high?
20. People analyzed in the groups in which they were randomized?
21. Quality

Results

Categorical


Vision disorder (Mean intraocular pressure (IOP) reduction >20%)

All Participants
Descriptive StatisticsBetween Arm Comparisons
A. Netarsudil/Latanaprost FDCP (n=238; comparison NR)B. Netarsudil 0.02% (n=244)C. Latanaprost 0.005% (n=236)
end of study
Percentage
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
A. Netarsudil/Latanaprost FDCP (n=238; comparison NR)B. Netarsudil 0.02% (n=244)C. Latanaprost 0.005% (n=236)

Vision disorder (Intraocular pressure (IOP), percent change from baseline)

All Participants
Descriptive StatisticsBetween Arm Comparisons
A. Netarsudil/Latanaprost FDCP (n=238; comparison NR)B. Netarsudil 0.02% (n=244)C. Latanaprost 0.005% (n=236)
end of study
Percentage
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
A. Netarsudil/Latanaprost FDCP (n=238; comparison NR)B. Netarsudil 0.02% (n=244)C. Latanaprost 0.005% (n=236)

Continuous


Harm/adverse event (Withdrawal due to adverse events)

All Participants
Descriptive StatisticsBetween Arm Comparisons
A. Netarsudil/Latanaprost FDCP (n=238; comparison NR)B. Netarsudil 0.02% (n=244)C. Latanaprost 0.005% (n=236)
vs.
end of study
Percentage
Relative risk (95% CI)
Patients
Within Arm ComparisonsNet Comparisons
A. Netarsudil/Latanaprost FDCP (n=238; comparison NR)B. Netarsudil 0.02% (n=244)C. Latanaprost 0.005% (n=236)
vs.

Harm/adverse event (Serious adverse events, none considered related to treatment)

All Participants
Descriptive StatisticsBetween Arm Comparisons
A. Netarsudil/Latanaprost FDCP (n=238; comparison NR)B. Netarsudil 0.02% (n=244)C. Latanaprost 0.005% (n=236)
end of study
Patients
Relative risk (95% CI)
Mean Difference (MD)
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
A. Netarsudil/Latanaprost FDCP (n=238; comparison NR)B. Netarsudil 0.02% (n=244)C. Latanaprost 0.005% (n=236)