Trial | NCT00822081  Report issue

Title

Comparison of the Fixed Combinations of Brimonidine/Timolol and Dorzolamide/Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    brimonidine dorzolamide timolol prostaglandin ...

  • Study Participants

    140
This study compares the efficacy and tolerability/comfort of brimonidine/timolol and dorzolamide/timolol in patients with open-angle glaucoma or ocular hypertension. In an investigator masked randomization process, each subject is allocated to recieve either brimonidine/timolol or dorzolamide/timolol as fixed-combination monotherapy or as an adjuctive to a prostoglandin analogue for a period of 12 weeks. After screening, patient returns at baseline, Month 1, and Month 3 for ophthalmic evaluations.
Study Started
Jan 31
2005
Primary Completion
Apr 30
2006
Study Completion
Apr 30
2006
Last Update
Jan 14
2009
Estimate

Drug brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination

1 drop BID in each eye

  • Other names: Combigan.

Drug dorzolamide hcl 2%/ timolol maleate 0.5% fixed combination

1 drop BID in each eye

  • Other names: Cosopt.

Drug brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy.

1 drop BID in each eye

  • Other names: Combigan.

Drug dorzolamide hcl 2%/timolol maleate 0.5% fixed combinatin as adjunctive to current prostaglandin therapy.

1 drop BID in each eye

  • Other names: Cosopt

1 Active Comparator

brimonidine/timolol. Fixed-combination monotherapy.

2 Active Comparator

dorzolamide/timolol. Fixed-combination monotherapy.

3 Active Comparator

prostaglandin analogue+ brimonidine/timolol fixed combination.

4 Active Comparator

prostaglandin analogue+dorzolamide/timolol fixed combination.

Criteria 

Inclusion Criteria:

Male or female over 18 yrs.
Female subjects of childbearing potential must have negative pregnancy test and provide contraception.
Subjects must have confirmed diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes.
Subjects who are or have been insufficiently responsive to IOP reducing monotherapy and use of either study medication is deemed appropriate.
Subjects able to complete questionnaires and provide informed consent.

Exclusion Criteria:

Female subjects who are pregnant, planning to become pregnant during study period, breast feeding or not practicing a reliable method of birth control.
Subjects wherein the study drugs are containdicated.
Subjects who have had introcular surgery with 6 months (3 months for laser).
Subjects with known side effects/ allergy or sensitivity to any component of study treatments.
Subjects with any uncontrolled systemic disease.
No Results Posted