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

Design Details

1. Study design

Arms

Arm NameArm Description
A. Brinzolamide 1.0% twice daily (n=134)
B. Brinzolamide 1.0% three times daily (n=133)
C. Dorzolamide 2.0% three times daily (n=131)
D. Placebo (n=65)

Sample Characteristics

1. N
A. Brinzolamide 1.0% twice daily (n=134)
B. Brinzolamide 1.0% three times daily (n=133)
C. Dorzolamide 2.0% three times daily (n=131)
D. Placebo (n=65)
Total
2. Baseline population
A. Brinzolamide 1.0% twice daily (n=134)
B. Brinzolamide 1.0% three times daily (n=133)
C. Dorzolamide 2.0% three times daily (n=131)
D. Placebo (n=65)
Total

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalVision disorderResponse to treatment (IOP reduction >5 mm Hg) or well controlled (IOP <22 mm Hg), 3 months
  • All Participants
  • 3 months
CategoricalHarm/adverse eventSerious adverse events
  • All Participants
  • 3 months

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 (Response to treatment (IOP reduction >5 mm Hg) or well controlled (IOP <22 mm Hg), 3 months)

All Participants
Descriptive StatisticsBetween Arm Comparisons
A. Brinzolamide 1.0% twice daily (n=134)B. Brinzolamide 1.0% three times daily (n=133)C. Dorzolamide 2.0% three times daily (n=131)D. Placebo (n=65)
3 months
Percentage
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
A. Brinzolamide 1.0% twice daily (n=134)B. Brinzolamide 1.0% three times daily (n=133)C. Dorzolamide 2.0% three times daily (n=131)D. Placebo (n=65)

Harm/adverse event (Serious adverse events)

All Participants
Descriptive StatisticsBetween Arm Comparisons
A. Brinzolamide 1.0% twice daily (n=134)B. Brinzolamide 1.0% three times daily (n=133)C. Dorzolamide 2.0% three times daily (n=131)D. Placebo (n=65)
3 months
Percentage
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
A. Brinzolamide 1.0% twice daily (n=134)B. Brinzolamide 1.0% three times daily (n=133)C. Dorzolamide 2.0% three times daily (n=131)D. Placebo (n=65)