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Adjunctive Study of AL-37807 Ophthalmic Suspension

Comparison of Safety and Efficacy of Al-37807 Ophthalmic Suspension vs. Timolol Gel Forming Solution and Vehicle, All Dosed Concomitantly With Xalatan in Patients With Open-Angle Glaucoma or Ocular Hypertension

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00620256
Enrollment
129
Registered
2008-02-21
Start date
2007-11-30
Completion date
2008-07-31
Last updated
2012-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open-Angle Glaucoma, Ocular Hypertension

Keywords

Glaucoma, Hypertension

Brief summary

The purpose of the study is to compare the safety and intraocular pressure-lowering efficacy of AL-37807 ophthalmic suspension vs. Timolol gel forming solution vs. AL-37807 vehicle, all dosed concomitantly with Xalatan, in patients with open-angle glaucoma or ocular hypertension.

Interventions

DRUGAL-37807 ophthalmic suspension, 0.1%
DRUGTimolol gel forming solution, 0.5%
OTHERAL-37807 ophthalmic solution vehicle

Sponsors

Alcon Research
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Open-angle glaucoma * Ocular hypertension * Must have been on Xalatan for at least 3 months * VA not worse than 0.60 * Other protocol-defined inclusion criteria may apply

Exclusion criteria

* Age related * Other protocol-defined

Design outcomes

Primary

MeasureTime frame
Mean change from baseline in intraocular pressureBaseline, up to 4 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026