NCT00620256

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 21, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

December 5, 2012

Status Verified

December 1, 2012

Enrollment Period

8 months

First QC Date

February 11, 2008

Last Update Submit

December 3, 2012

Conditions

Open-Angle GlaucomaOcular Hypertension

Keywords

GlaucomaHypertension

Outcome Measures

Primary Outcomes (1)

  • Mean change from baseline in intraocular pressure

    Baseline, up to 4 weeks

Study Arms (3)

AL-37807

EXPERIMENTAL

AL-37807 ophthalmic suspension, 0.1%, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks

Drug: AL-37807 ophthalmic suspension, 0.1%Drug: Latanoprost ophthalmic solution

Timolol

ACTIVE COMPARATOR

Timolol gel forming solution, 0.5%, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks

Drug: Timolol gel forming solution, 0.5%Drug: Latanoprost ophthalmic solution

AL-37807 vehicle

PLACEBO COMPARATOR

AL-37807 ophthalmic solution vehicle, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks

Drug: AL-37807 ophthalmic suspension, 0.1%Other: AL-37807 ophthalmic solution vehicleDrug: Latanoprost ophthalmic solution

Interventions

AL-37807 ophthalmic suspension, 0.1%DRUG
AL-37807AL-37807 vehicle
Timolol gel forming solution, 0.5%DRUG
Timolol
AL-37807 ophthalmic solution vehicleOTHER
AL-37807 vehicle
Latanoprost ophthalmic solutionDRUG
Also known as: XALATAN
AL-37807AL-37807 vehicleTimolol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Open-angle glaucoma
  • Ocular hypertension
  • Must have been on Xalatan for at least 3 months
  • VA not worse than 0.60

You may not qualify if:

  • Age related

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contact Alcon Call Center at 1-888-451-3937

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular HypertensionGlaucomaHypertension

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

Eye DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2008

First Posted

February 21, 2008

Study Start

November 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

December 5, 2012

Record last verified: 2012-12

Locations

US(1)