Phase 3
N=371
Efficacy Study of Travoprost APS Versus TRAVATAN
Open Angle Glaucoma · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00848536 ↗Enrolled (actual)
371
Serious AEs
0.8%
Results posted
Mar 2011
Primary outcome: Primary: Mean Intraocular Pressure at 9:00 am — 17.9; 18.1 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Travoprost 0.004% (POLYQUAD-preserved) Eye Drops, Solution (Drug); Travoprost 0.004% (BAK-preserved) Eye Drops, Solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Intraocular Pressure at 9:00 am |
17.9; 18.1 | — |
| PRIMARY Mean Intraocular Pressure at 11:00 am |
17.4; 17.5 | — |
| PRIMARY Mean Intraocular Pressure at 4:00 pm |
16.9; 17.1 | — |
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 Criteria
- 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 Criteria
- Females of childbearing potential not meeting conditions set in the protocol.
- Severe central visual field loss.
- Angle Shaffer grade 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.
Data sourced from ClinicalTrials.gov (NCT00848536). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.