SIMBRINZA® Suspension BID as an Adjunctive to Prostaglandin Analogue (PGA)

Browse trials for

• Glaucoma, Open-Angle 929
• Ocular Hypertension 649

Glaucoma, Open-Angle

929 studies on the registry are indexed under Glaucoma, Open-Angle; 122 are open to participants now.

This study's enrollment of 290 is above the median of 80 across 700 interventional studies indexed under Glaucoma, Open-Angle.

Lead sponsor

Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.

Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.

Study arms

• Experimental
  SIMBRINZA + PGA

  Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00) plus designated prostaglandin analogue, 1 drop instilled in each eye once per day in the evening for 42 days

  Drug: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension · Drug: Prostaglandin analogue

• Other
  Vehicle + PGA

  Brinz/brim vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00) plus designated prostaglandin analogue, 1 drop instilled in each eye once per day in the evening for 42 days

  Drug: Brinz/brim vehicle · Drug: Prostaglandin analogue

Interventions

• DrugBrinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension

  Also known as: SIMBRINZA® suspension

• DrugBrinz/brim vehicle

  Inactive ingredients used as a placebo for masking purposes

• DrugProstaglandin analogue

  Also known as: TRAVATAN® PQ (Travoprost ophthalmic solution with PQ, 0.004%), LUMIGAN® (Bimatoprost ophthalmic solution, 0.01%), XALATAN® (Latanoprost ophthalmic solution, 0.005%)

Primary outcomes

1. Mean Change From Baseline (on PGA) in Diurnal IOP (Mean of 09:00 and 11:00 Time Points) at Week 6

   IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.

   Time frame: Baseline, Week 6

Secondary outcomes

1. Mean Diurnal IOP at Week 6

   IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis.

   Time frame: Week 6

2. Mean Percentage Change From Baseline in Diurnal IOP at Week 6

   IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.

   Time frame: Baseline, Week 6

3. Mean Change From Baseline in IOP at 11:00 at Week 6

   IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 11:00 AM. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.

   Time frame: Baseline, Week 6

4. Mean Percentage Change From Baseline in IOP at 11:00 at Week 6

   IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 11:00 AM. A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.

   Time frame: Baseline, Week 6

5. Mean Change From Baseline in IOP at 09:00 at Week 6

   IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 09:00 AM. Baseline is defined as the average of the 9:00 hour values at both Eligibility visits. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.

   Time frame: Baseline, Week 6

6. Mean Percentage Change From Baseline at 09:00 at Week 6

   IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 9:00 AM. Baseline is defined as the average of the 9:00 hour values at both Eligibility visits.A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.

   Time frame: Baseline, Week 6

Baseline characteristics

Study documents

• Statistical analysis plan · Mar 12, 2018
• Study protocol · Mar 30, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No