Efficacy and Safety of Travoprost 0.004% Versus Tafluprost 0.0015% in Patients With Primary Open-angle Glaucoma or Ocular Hypertension

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00966940
• Collaborator: (none)
• Enrollment: 51
• Arms: 2
• Duration (Months): 5.9

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and efficacy of Travoprost 0.004% and Tafluprost 0.0015% in patients with primary open angle glaucoma or ocular hypertension when both medications are administered in the evening.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Drug: Travoprost 0.004% ophthalmic solution (TRAVATAN); Drug: Tafluprost 0.0015% ophthalmic solution	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 51 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: The Efficacy and Safety of Travoprost, 0.004% Versus Tafluprost, 0.0015% in Primary Open-Angle Glaucoma or Ocular Hypertensive Patients
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: Travoprost-to-tafluprost Travoprost first, with tafluprost second. Each product dosed for six weeks.	Drug: Travoprost 0.004% ophthalmic solution (TRAVATAN); One drop in the qualifying eye(s) each evening at 6:00 PM for 6 weeks, topical administration; Other Names: TRAVATAN ; Drug: Tafluprost 0.0015% ophthalmic solution; One drop in the qualifying eye(s) each evening at 6:00 PM for 6 weeks, topical administration
Other: Tafluprost-to-travoprost Tafluprost first, with travoprost second. Each product dosed for six weeks.	Drug: Travoprost 0.004% ophthalmic solution (TRAVATAN); One drop in the qualifying eye(s) each evening at 6:00 PM for 6 weeks, topical administration; Other Names: TRAVATAN ; Drug: Tafluprost 0.0015% ophthalmic solution; One drop in the qualifying eye(s) each evening at 6:00 PM for 6 weeks, topical administration

Outcome Measures

Primary Outcome Measures

1. Mean Intraocular Pressure (IOP) at 8:00 PM [6 weeks]

   Intraocular pressure was measured by Goldmann applanation tonometry.

Secondary Outcome Measures

1. Mean Intraocular Pressure (IOP) at 8:00 AM [6 weeks]

   Intraocular pressure was measured by Goldmann applanation tonometry.

2. Mean Intraocular Pressure (IOP) at 10:00 AM [6 weeks]

   Intraocular pressure was measured by Goldmann applanation tonometry.

3. Mean Intraocular Pressure (IOP) at 12:00 PM [6 weeks]

   Intraocular pressure was measured by Goldmann applanation tonometry.

4. Mean Intraocular Pressure (IOP) at 2:00 PM [6 weeks]

   Intraocular pressure was measured by Goldmann applanation tonometry.

5. Mean Intraocular Pressure (IOP) at 4:00 PM [6 weeks]

   Intraocular pressure was measured by Goldmann applanation tonometry.

6. Mean Intraocular Pressure (IOP) at 6:00 PM [6 weeks]

   Intraocular pressure was measured by Goldmann applanation tonometry.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• An EC-reviewed and approved (for use in this study) informed consent form must be read, signed, and dated by the participating patient as well as signed and dated by the individual (Principal Investigator or other site personnel) obtaining the informed consent, before conducting the Screening Visit and prior to initiation of study procedures.

• Patients must be at least 21 years of age.

• Must be able to follow instructions and be willing and able to attend required study visits.

• Must have a clinical diagnosis of ocular hypertension or primary open-angle glaucoma in at least one eye (qualifying eye).

• Currently treated patients, in the investigator's judgment, should require a change in treatment for reasons of improved efficacy, tolerability or compliance.

• Must have IOP considered to be safe, in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the trial.

• Must have an intraocular pressure of > 21 mm Hg in at least one eye at 08:00 and > 19 mm Hg in the same eye at 16:00, and < 35 mm Hg in both eyes at all diurnal time points at Visit 2.

• Must have best corrected visual acuity of 6/60 (20/200 Snellen) or better in each eye.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Presence of other primary or secondary glaucomas not listed in inclusion criterion.

• Presence of extreme narrow angle with complete or partial closure in either eye, as measured by gonioscopy (occludable angles treated with a patent iridectomy are acceptable).

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

• Any opacity or patient uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber of either eye.

• Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.

• Intraocular conventional surgery or laser surgery in qualifying eye(s) less than three months prior to Visit 1.

• Risk of visual field or visual acuity worsening as a consequence of participation in the trial, in the investigator's best judgment.

• Progressive retinal or optic nerve disease from any cause apart from glaucoma.

• Women of childbearing potential not using reliable means of birth control, or pregnant or lactating females.

• Any clinically significant, serious, or severe medical or psychiatric condition.

• A condition, which in the opinion of the investigator, would interfere with optimal participation in the study, or which would present a special risk to the patient.

• Participation in any other investigational study within 30 days prior to Visit 2.

• Known medical history of allergy or sensitivity to any components of the preparations to be used in this trial that is deemed clinically significant in the opinion of the investigator.

• Use of systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers,alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for 7 days prior to Visit 2 or an anticipated change in the dosage during the course of the study.

• Anticipated use of systemic corticosteroids, by any route except inhaled, for greater than two weeks during the trial.

• A history of, or at risk for uveitis or cystoid macular edema (CME).

• History of ocular herpes simplex.

• Unwillingness to accept the risk of iris, skin, or eyelash changes associated with prostaglandin therapy.

• 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: NCT00966940
• Other Study ID Numbers: SMA-08-16
• First Posted: Aug 27, 2009
• Last Update Posted: Jun 20, 2012
• Last Verified: May 1, 2012

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

Study Results

Participant Flow

Recruitment Details	Patients were recruited from four private practices located in Germany.

Arm/Group Title	Travoprost-to-tafluprost	Tafluprost-to-travoprost
Arm/Group Description	Travoprost, then tafluprost	Tafluprost, then travoprost
Period Title: Period 1, First 6 Weeks
STARTED	28	23
COMPLETED	25	23
NOT COMPLETED	3	0
Period Title: Period 1, First 6 Weeks
STARTED	25	23
COMPLETED	25	23
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Travoprost-to-tafluprost	Tafluprost-to-travoprost	Total
Arm/Group Description	Travoprost, then tafluprost	Tafluprost, then travoprost	Total of all reporting groups
Overall Participants	28	23	51
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.1 (7.8)	68.5 (10.5)	68.8 (9.0)
Sex: Female, Male (Count of Participants)
Female	16 57.1%	15 65.2%	31 60.8%
Male	12 42.9%	8 34.8%	20 39.2%

Outcome Measures

1. Primary Outcome

Title	Mean Intraocular Pressure (IOP) at 8:00 PM
Description	Intraocular pressure was measured by Goldmann applanation tonometry.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.

Arm/Group Title	Travoprost	Tafluprost
Arm/Group Description	One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically	One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
Measure Participants	48	48
Mean (Standard Deviation) [mm Hg]	17.1 (3.17)	17.7 (3.23)

2. Secondary Outcome

Title	Mean Intraocular Pressure (IOP) at 8:00 AM
Description	Intraocular pressure was measured by Goldmann applanation tonometry.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.

Arm/Group Title	Travoprost	Tafluprost
Arm/Group Description	One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically	One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
Measure Participants	48	48
Mean (Standard Deviation) [mm Hg]	17.0 (2.36)	17.5 (2.20)

3. Secondary Outcome

Title	Mean Intraocular Pressure (IOP) at 10:00 AM
Description	Intraocular pressure was measured by Goldmann applanation tonometry.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.

Arm/Group Title	Travoprost	Tafluprost
Arm/Group Description	One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically	One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
Measure Participants	48	48
Mean (Standard Deviation) [mm Hg]	16.7 (2.39)	17.3 (2.50)

4. Secondary Outcome

Title	Mean Intraocular Pressure (IOP) at 12:00 PM
Description	Intraocular pressure was measured by Goldmann applanation tonometry.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.

Arm/Group Title	Travoprost	Tafluprost
Arm/Group Description	One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically	One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
Measure Participants	48	48
Mean (Standard Deviation) [mm Hg]	16.7 (2.47)	17.2 (2.46)

5. Secondary Outcome

Title	Mean Intraocular Pressure (IOP) at 2:00 PM
Description	Intraocular pressure was measured by Goldmann applanation tonometry.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.

Arm/Group Title	Travoprost	Tafluprost
Arm/Group Description	One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically	One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
Measure Participants	48	48
Mean (Standard Deviation) [mm Hg]	16.9 (2.69)	17.3 (2.77)

6. Secondary Outcome

Title	Mean Intraocular Pressure (IOP) at 4:00 PM
Description	Intraocular pressure was measured by Goldmann applanation tonometry.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.

Arm/Group Title	Travoprost	Tafluprost
Arm/Group Description	One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically	One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
Measure Participants	48	48
Mean (Standard Deviation) [mm Hg]	17.1 (2.85)	17.6 (2.80)

7. Secondary Outcome

Title	Mean Intraocular Pressure (IOP) at 6:00 PM
Description	Intraocular pressure was measured by Goldmann applanation tonometry.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.

Arm/Group Title	Travoprost	Tafluprost
Arm/Group Description	One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically	One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
Measure Participants	48	48
Mean (Standard Deviation) [mm Hg]	16.9 (3.12)	17.6 (3.13)

Adverse Events

Time Frame	Adverse events were collected for the duration of the study: 10-September-2009 to 2-March-2010.
Arm/Group Title	Travoprost		Tafluprost
Arm/Group Description	One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically		One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
All Cause Mortality
	Travoprost		Tafluprost
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Travoprost		Tafluprost
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/48 (0%)
Other (Not Including Serious) Adverse Events
	Travoprost		Tafluprost
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/48 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.