Trial Outcomes & Findings for A Single Dose Comfort Comparison of Travatan Z in One Eye Versus Xalatan in the Opposite Eye in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension (NCT NCT00527592)

Results Overview

Comfort was assessed by the patient and recorded on a scale of 0 to 100, with 0 = perfect comfort and 100 = worse discomfort imaginable.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

54 participants

Primary outcome timeframe

5 seconds

Results posted on

2012-05-18

Participant Flow

Patients were recruited from two US glaucoma specialty clinics from 6/8/2007 to 8/13/2008. Eligible patients having a diagnosis of open-angle glaucoma or ocular hypertension in both eyes were enrolled.

54 patients were enrolled in the study. Qualified patients ceased prostaglandin use for 3-5 days (wash-out) prior to Visit 2 (randomization).

Participant milestones

Participant milestones
Measure	Travoprost/Latanoprost Travoprost assigned to one eye, with latanoprost assigned to the fellow eye for intra-individual control.
Overall Study STARTED	54
Overall Study COMPLETED	54
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Single Dose Comfort Comparison of Travatan Z in One Eye Versus Xalatan in the Opposite Eye in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Travoprost/Latanoprost n=54 Participants Travoprost assigned to one eye, with latanoprost assigned to the fellow eye for intra-individual control.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=93 Participants
Age, Categorical >=65 years	24 Participants n=93 Participants
Sex: Female, Male Female	37 Participants n=93 Participants
Sex: Female, Male Male	17 Participants n=93 Participants

PRIMARY outcome

Timeframe: 5 seconds

Population: Intent to treat: All patients who received test article and completed the trial.

Comfort was assessed by the patient and recorded on a scale of 0 to 100, with 0 = perfect comfort and 100 = worse discomfort imaginable.

Outcome measures

Outcome measures
Measure	Travoprost n=54 Eyes One drop in the study eye, single dose	Latanoprost n=54 Eyes One drop in the study eye, single dose
Comfort Immediately After Dosing	7.8 Units on a scale Standard Deviation 16.1	7.1 Units on a scale Standard Deviation 16.2

Adverse Events

Travoprost

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Latanoprost

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Medical Affairs

Alcon Research, Ltd.

Phone: 1-800-862-5266

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor does not guarantee the Investigator's right to publish study results since this is a pilot trial with results intended primarily for internal use. Alcon reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER