Table 1.
Comparison studies of the efficacy and safety of fixed combinations relative to their active components
| Study (n) | Study arms | Study duration | Timing of IOP measurements | Efficacy in IOP lowering | Tolerability |
|---|---|---|---|---|---|
| FCDT vs each component7 (335) | FCDT bid Dorzolamide tid Timolol bid |
3 months | 8:30 AM (trough) and 10:30 AM (peak) at baseline, day 1, week 2, and months 1, 2, and 3 | FCDT more effective than timolol or dorzolamide at all measurements | No significant difference among treatment groups in the overall incidence of adverse events |
| FCDT vs each component8 (253) | FCDT bid Dorzolamide tid Timolol bid |
3 months | 9 AM (trough) and 11 AM (peak) at baseline, week 2, and months 1, 2, and 3 | FCDT more effective than timolol or dorzolamide at 7 of 8 measurements | Similar incidence of adverse events with FCDT vs dorzolamide; fewer adverse events with timolol vs FCDT |
| FCLT vs each component9 (418) | FCLT qd (AM) Latanoprost qd (PM) Timolol bid |
6 months (masked phase) | 8 AM, 10 AM, and 4 PM at baseline and weeks 2, 13, and 26; 8 AM at week 6 | FCLT more effective than timolol or latanoprost across 6 months of treatment | Bulbar conjunctival hyperemia reported for twice as many latanoprost patients as FCLT patients; lower incidence with timolol |
| FCLT vs each component10 (436) | FCLT qd (AM) Latanoprost qd (AM) Timolol bid |
6 months (masked phase) | 8 AM, 10 AM, and 4 PM at baseline and weeks 2, 13, and 26; 8 AM at week 6 | FCLT more effective than timolol or latanoprost across 6 months of treatment | Conjunctival hyperemia reported for twice as many FCLT patients as latanoprost patients; lower incidence with timolol |
| FCBT vs each component11 (1159) | FCBT bid Brimonidine tid Timolol bid | 1 year | 8 AM, 10 AM, 3 PM, and 5 PM at baseline, weeks 2 and 6, and months 3, 6, and 12; 8 AM and 10 AM at month 9 | FCBT more effective than timolol at all measurements and more effective than brimonidine at all 8 AM, 10 AM, and 3 PM measurements | Lower incidence of adverse events (ocular allergy/inflammation, oral dryness) and fewer discontinuations due to adverse events with FCBT vs brimonidine; fewer adverse events with timolol vs FCBT |
| FCBimT vs each component12 (1061) | FCBimT qd (AM) Bimatoprost qd (PM) Timolol bid |
3 months | 8 AM, 10 AM, and 4 PM at baseline, weeks 2 and 6, and month 3 | FCBimT more effective than timolol at all measurements and bimatoprost at 5 of 9 measurements | Lower incidence of adverse events (conjunctival hyperemia) and fewer discontinuations due to adverse events with FCBimT vs bimatoprost; fewer adverse events with timolol vs FCBimT |
| FCTT vs each component13 (263) | FCTT qd (AM) Travoprost (qd) Timolol (bid) |
3 months | 8 AM, 10 AM, and 4 PM at baseline, weeks 2 and 6, and month 3 | FCTT more effective than timolol at all measurements and travoprost at 7 of 9 measurements | Similar incidence of conjunctival hyperemia with FCTT vs travoprost; lower incidence of conjunctival hyperemia with timolol vs FCTT |
Abbreviations: FCDT, fixed-combination dorzolamide/timolol (Cosopt); FCLT, fixed-combination latanoprost/timolol (Xalacom); FCBT, fixed-combination brimonidine/timolol (Combigan); FCBimT, fixed-combination bimatoprost/timolol (Ganfort); FCTT, fixed-combination travoprost/timolol (DuoTrav); bid, twice daily; tid, 3 times daily; qd, daily.