Safety and Intraocular Pressure (IOP) Lowering Efficacy of Low Dose Travoprost

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00637130
• Date of registration: 29/02/2008
• Prospective Registration: No
• Primary sponsor: Alcon Research
• Public title: Safety and Intraocular Pressure (IOP) Lowering Efficacy of Low Dose Travoprost
• Scientific title: Safety and IOP Lowering Efficacy of Low Dose Travoprost Ophthalmic Solutions Dosed BID Compared to TRAVATAN® in Patients With Open-Angle Glaucoma or Ocular Hypertension
• Date of first enrolment: October 2007
• Target sample size: 138
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00637130
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients 18 years of age or older, either sex or race with open-angle glaucoma or
confirmed ocular hypertension

- Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

- Age related

- Other protocol-defined exclusion criteria may apply



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Ocular Hypertension

Open-angle Glaucoma

Intervention(s)

Drug: Travoprost ophthalmic solution, 0.0012%

Drug: Travoprost ophthalmic solution, 0.001%

Drug: TRAVATAN

Drug: Travoprost ophthalmic solution, 0.0008%

Other: Vehicle

Primary Outcome(s)

Mean Intraocular Pressure [Time Frame: Up to 2 weeks]

Secondary ID(s)

C-06-11

Source(s) of Monetary Support

Please refer to primary and secondary sponsors