Status:
COMPLETED
Efficacy Study of Travoprost APS Versus TRAVATAN
Lead Sponsor:
Alcon Research
Conditions:
Open Angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A Multi-Center Double-masked Study of the Safety and Efficacy of Travoprost APS Compared to TRAVATAN in Patients with Open-angle Glaucoma or Ocular Hypertension
Eligibility Criteria
Inclusion
- 18 years of age or older, either gender and any race.
- Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT).
- Not currently on any IOP-lowering medication or currently on a stable treatment (i.e, at least 30 days) with and IOP-lowering monotherapy.
- All patients: Mean IOP in same eye (at both Eligibility 1 \& 2 Visits):
- ≥ 24 and ≤ 36 mmHg at 9 AM; and ≥ 21 and ≤ 36 mmHg at 11 AM \& 4 PM.
- Other protocol-defined inclusion criteria may apply.
Exclusion
- Females of childbearing potential not meeting conditions set in the protocol.
- Severe central visual field loss.
- Angle Shaffer grade \< 2.
- Cup/disc ratio \> 0.8 (horizontal or vertical measurement).
- Best corrected visual acuity (VA) score worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal).
- Intraocular surgery or trauma within last 6 months.
- Any abnormality preventing reliable applanation tonometry.
- History of or current ocular pathology (including severe dry eye) that would affect the conduct of the study.
- Allergy/hypersensitivity to study medications.
- Unable to discontinue use of all IOP-lowering medications for a minimum wash-out period of 5 to 28 days prior to the Eligibility Visit.
- Less than 30 days stable dosing regimen of medications used on a chronic basis that may affect IOP.
- Use of any additional topical or systemic ocular hypotensive medication during the study.
- Therapy with another investigational agent within 30 days prior to the Screening visit.
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
371 Patients enrolled
Trial Details
Trial ID
NCT00848536
Start Date
March 1 2009
End Date
January 1 2010
Last Update
April 6 2012
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