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

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00527592
• Collaborator: (none)
• Enrollment: 54
• Arms: 2
• Duration (Months): 15

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the comfort of Travatan Z in one eye and Xalatan in the opposite eye in patients with primary open-angle glaucoma or ocular hypertension.

Condition or Disease	Intervention/Treatment	Phase
Open-Angle Glaucoma; Ocular Hypertension	Drug: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®); Drug: Latanoprost ophthalmic solution 0.005% (XALATAN®)	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: May 1, 2007
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Travoprost Travoprost assigned to one eye, with latanoprost assigned to the fellow eye for intra-individual control. One drop, single dose. The eye, and the order in which the first test medicine was instilled (either travoprost or latanoprost), was randomly assigned.	Drug: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®); Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop, single dose. Referred to as travoprost.; Other Names: TRAVATAN Z®
Active Comparator: Latanoprost Latanoprost assigned to one eye, with travoprost assigned to the fellow eye for intra-individual control. One drop, single dose. The eye, and the order in which the first test medicine was instilled (either travoprost or latanoprost), was randomly assigned.	Drug: Latanoprost ophthalmic solution 0.005% (XALATAN®); Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop, single dose. Referred to as latanoprost.; Other Names: XALATAN®

Outcome Measures

Primary Outcome Measures

1. Comfort Immediately After Dosing [5 seconds]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 years of age or older.

• Clinical diagnosis of ocular hypertension, primary open-angle, pigment dispersion, or exfoliation glaucoma in both eyes.

• Best corrected visual acuity of 20/200 Snellen or better in each eye.

• Intraocular pressure within protocol-specified range.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Any abnormality preventing reliable applanation tonometry in the study eye(s).

• Any eye conditions or procedures as specified in protocol.

• Progressive retinal or optic nerve disease from any cause.

• Use of contact lenses in the study eye(s).

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT00527592
• Other Study ID Numbers: SMA-07-01
• First Posted: Sep 11, 2007
• Last Update Posted: May 18, 2012
• Last Verified: May 1, 2012

• Keywords provided by Alcon Research: Comfort
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Travoprost; Pharmaceutical Solutions; Latanoprost; Ophthalmic Solutions

Study Results

Participant Flow

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

Arm/Group Title	Travoprost/Latanoprost
Arm/Group Description	Travoprost assigned to one eye, with latanoprost assigned to the fellow eye for intra-individual control.
Period Title: Overall Study
STARTED	54
COMPLETED	54
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Travoprost/Latanoprost
Arm/Group Description	Travoprost assigned to one eye, with latanoprost assigned to the fellow eye for intra-individual control.
Overall Participants	54
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	30 55.6%
>=65 years	24 44.4%
Sex: Female, Male (Count of Participants)
Female	37 68.5%
Male	17 31.5%

Outcome Measures

1. Primary Outcome

Title	Comfort Immediately After Dosing
Description	Comfort was assessed by the patient and recorded on a scale of 0 to 100, with 0 = perfect comfort and 100 = worse discomfort imaginable.
Time Frame	5 seconds

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Travoprost	Latanoprost
Arm/Group Description	One drop in the study eye, single dose	One drop in the study eye, single dose
Measure Participants	54	54
Measure Eyes	54	54
Mean (Standard Deviation) [Units on a scale]	7.8 (16.1)	7.1 (16.2)

Adverse Events

Time Frame	Adverse events were collected for the duration of the study and 14 days post study exit.
Adverse Event Reporting Description	This reporting group includes all patients who received test article.
Arm/Group Title	Travoprost		Latanoprost
Arm/Group Description	One drop in the study eye, single dose		One drop in the study eye, single dose
All Cause Mortality
	Travoprost		Latanoprost
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Travoprost		Latanoprost
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/54 (0%)
Other (Not Including Serious) Adverse Events
	Travoprost		Latanoprost
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/54 (0%)

Limitations/Caveats

None specified.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.