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Phase 3 N=371 Randomized Double-blind Treatment

Efficacy Study of Travoprost APS Versus TRAVATAN

Open Angle Glaucoma · Ocular Hypertension

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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