Table 1 General characteristics of trials on glaucoma interventions (n = 79) with results both in the ClinicalTrials.gov and the publication.

From: Safety reporting in trials on glaucoma interventions registered in ClinicalTrials.gov and corresponding publications

 

No. (%)

Primary completion

 

  Before FDAA Final Rulea

58 (73)

  After FDAA Final Rulea

21 (27)

Trial phase

 

  2

16 (20)

  3

34 (43)

  4

29 (37)

Masking

 

None (Open Label)

23 (29.1)

Single Blinded

11 (13.9)

Double Blinded

22 (27.9)

Triple Blinded

12 (15.2)

Quadruple Blinded

11 (13.9)

Control

 

None

16 (20.3)

Active

50 (63.3)

Placebo

8 (10.1)

Both

5 (6.3)

Intervention model

 

Parallel Assignment

57 (72.2)

Single Assignment

17 (21.5)

Crossover Assignment

5 (6.3)

Industry sponsored

 

  Yes

72 (91)

  No

7 (9)

Publication before last update on ClinicalTrials.gov

 

  Yes

30 (37)

  No

49 (62)

Type of intervention

 

  Fixed combination eye drops

28 (35)

  Prostaglandin analogues eye drops

22 (27)

  Rho-inhibitor eye drops

7 (9)

  Sustained releasing medications

9 (11)

  Surgery

4 (5)

  Anti-VEGF medication

3 (4)

  Experimental medications

3 (4)

  Otherb

3(4)

  1. VEGF – vascular endothelial growth factor.
  2. aFDAA final Rule, January 18, 2017, requiring reporting of all anticipated and unanticipated adverse events and all-cause mortality data in tabular summaries15.
  3. bCategorized as “other” if fewer than 3 studies were available. The three trials tested phentolamine, fluticasone, and oral acetazolamide/dexamethasone eye drops, respectively.