Safety and Efficacy Study of BETOPTIC S 0.25% and Timolol Gel-forming Solution 0.25% and 0.5% in Pediatric Patients With Glaucoma or Ocular Hypertension

Browse trials for

• Glaucoma 1,818
• Ocular Hypertension 649
• Hypertension 6,689

Keywords

• Glaucoma
• Ocular Hypertension

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 105 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.

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
  Betaxolol

  Two doses daily for 12 weeks

  Drug: BETOPTIC S (betaxolol HCl)

• Experimental
  TGFS 0.25%

  Two doses daily for 12 weeks

  Drug: Timolol Gel-forming Solution (TGFS)

• Experimental
  TGFS 0.5%

  Two doses daily for 12 weeks

  Drug: Timolol Gel-forming Solution (TGFS)

Interventions

• DrugBETOPTIC S (betaxolol HCl)

  betaxolol HC)

• DrugTimolol Gel-forming Solution (TGFS)

  timolol maleate 0.25% and 0.5%

Primary outcomes

1. Mean change from baseline in IOP

   Time frame: Up to Week 12

Publications

• Plager DA, Whitson JT, Netland PA, Vijaya L, Sathyan P, Sood D, Krishnadas SR, Robin AL, Gross RD, Scheib SA, Scott H, Dickerson JE; BETOPTIC S Pediatric Study Group. Betaxolol hydrochloride ophthalmic suspension 0.25% and timolol gel-forming solution 0.25% and 0.5% in pediatric glaucoma: a randomized clinical trial. J AAPOS. 2009 Aug;13(4):384-90. doi: 10.1016/j.jaapos.2009.04.017. PubMed 19683191 ↗