Clinical trial
A Double-Masked, Parallel-Group, Efficacy and Safety Study of Brinzolamide 1.0% (AZOPT) as Adjunctive Therapy to Travoprost 0.004% (TRAVATAN) in Patients With Chronic Angle-Closure Glaucoma
Name
MS-06-01
Description
To evaluate the IOP (Intraocular Pressure) lowering efficacy and safety of Brinzolamide 1.0% (Azopt), dosed twice daily as adjunctive therapy in patients treated with Travoprost 0.004% (Travatan) once daily. The study is double masked. The patients will receive either treatment for 12 weeks.
Trial arms
Trial start
2006-05-01
Estimated PCD
2008-03-01
Trial end
2008-03-01
Status
Terminated
Phase
Early phase I
Treatment
Travoprost 0.004% + Brinzolamide 1.0%
Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily)
Arms:
Travoprost 0.004% + Brinzolamide 1.0%
Travoprost 0.004% + Tears Natural
Travoprost 0.004% (once daily) + Tears Naturale (twice daily)
Arms:
Travoprost 0.004% + Tears Natural
Size
37
Primary endpoint
Mean IOP (Intraocular Pressure)
Screening: Week 12; (At 9 am and 4 pm time points)
Eligibility criteria
Inclusion Criteria:
* ≥ 18 years;
* CACG (Chronic Angle Closure Glaucoma) ≥ 1eye
* have been treated with PGA (prostaglandin analogues) once daily ≥ 2 weeks prior to the screening visit and IOP=19-32 mmHg (millimeters mercury) in at least one eye and ≤ 32 mmHg in both eyes
* clinical stability of VA (Visual Acuity) and optic nerve throughout the study
Exclusion Criteria:
* Abnormality restricts exam of the fundus or anderior chamber
* conjunctivitis, keratitis or uveitis
* unable to be discontinued from using all ocular hypotensive medication(s) except Travatan (Travoprost 0.004%) and/or Azopt (Brinzolamide 1.0%) for 12days-4weeks
* ocular surgery prior to the study
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 37, 'type': 'ACTUAL'}}
Updated at
2023-12-05
1 organization
2 products
1 indication
Product
Travoprost + BrinzolamideIndication
Intraocular PressureOrganization
Alcon ResearchProduct
Travoprost