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

Design Details

1. Study design

Arms

Arm NameArm Description
A. Latanaprostene bunod 0.024% four times per day (n=562)
B. Timolol 0.5% twice per day (n=269)

Sample Characteristics

1. N
A. Latanaprostene bunod 0.024% four times per day (n=562)
B. Timolol 0.5% twice per day (n=269)
Total
2. Baseline population
A. Latanaprostene bunod 0.024% four times per day (n=562)
B. Timolol 0.5% twice per day (n=269)
Total

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalVision disorderIntraocular pressure (IOP) ≤18 mmHg at all timepoints
  • All Participants
  • end of study
CategoricalVision disorderIntraocular pressure (IOP) reduced ≥25% at all timepoints
  • All Participants
  • end of study
ContinuousHarm/adverse eventSerious adverse events
  • All Participants
  • end of study
ContinuousHarm/adverse eventWithdrawal due to adverse events
  • 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 (Intraocular pressure (IOP) ≤18 mmHg at all timepoints)

All Participants
Descriptive StatisticsBetween Arm Comparisons
A. Latanaprostene bunod 0.024% four times per day (n=562)B. Timolol 0.5% twice per day (n=269)
vs.
end of study
Percentage
p value
Within Arm ComparisonsNet Comparisons
A. Latanaprostene bunod 0.024% four times per day (n=562)B. Timolol 0.5% twice per day (n=269)
vs.

Vision disorder (Intraocular pressure (IOP) reduced ≥25% at all timepoints)

All Participants
Descriptive StatisticsBetween Arm Comparisons
A. Latanaprostene bunod 0.024% four times per day (n=562)B. Timolol 0.5% twice per day (n=269)
vs.
end of study
Percentage
p value
Within Arm ComparisonsNet Comparisons
A. Latanaprostene bunod 0.024% four times per day (n=562)B. Timolol 0.5% twice per day (n=269)
vs.

Continuous


Harm/adverse event (Serious adverse events)

All Participants
Descriptive StatisticsBetween Arm Comparisons
A. Latanaprostene bunod 0.024% four times per day (n=562)B. Timolol 0.5% twice per day (n=269)
end of study
Percentage
Relative risk (RR) (95% CI)
Mean Difference (MD)
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
A. Latanaprostene bunod 0.024% four times per day (n=562)B. Timolol 0.5% twice per day (n=269)

Harm/adverse event (Withdrawal due to adverse events)

All Participants
Descriptive StatisticsBetween Arm Comparisons
A. Latanaprostene bunod 0.024% four times per day (n=562)B. Timolol 0.5% twice per day (n=269)
vs.
end of study
Percentage
Relative risk (RR) (95% CI)
Within Arm ComparisonsNet Comparisons
A. Latanaprostene bunod 0.024% four times per day (n=562)B. Timolol 0.5% twice per day (n=269)
vs.