Travatan Versus Timoptic in Treating Open-angle Glaucoma or Ocular Hypertension

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00763061
• Collaborator: (none)
• Enrollment: 111
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 4.8

Study Details

Study Description

Brief Summary

To evaluate the Intraocular Pressure (IOP) lowering efficacy and safety of Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Drug: Travoprost 0.004% Ophthalmic Solution (Travatan); Drug: Timolol 0.5% Ophthalmic Solution (Timoptic)	Phase 4

Detailed Description

To evaluate the IOP lowering efficacy and safety fo Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 111 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Twelve-Week, Double Masked, Parallel Group, Study of Travoprost 0.004% Compared to Timolol 0.5% in Patients With Open-Angle Glaucoma or Ocular Hypertension
• Study Start Date: May 1, 2006
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Travoprost 0.004% Travoprost 0.004%	Drug: Travoprost 0.004% Ophthalmic Solution (Travatan); Travoprost at 9 AM + Placebo & 9 PM
Active Comparator: Timolol 0.5% Timolol 0.5%	Drug: Timolol 0.5% Ophthalmic Solution (Timoptic); Timolol in each eye, twice daily at 9 AM & 9 PM

Outcome Measures

Primary Outcome Measures

1. Mean Intraocular Pressure (IOP) at 9 AM [At Week 12 - At the 9 AM time point for the patient's worse eye.]

   Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.

2. Week 12 - Mean IOP At 4 PM [At the 4 PM time point for the patient's worse eye.]

   Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.

Secondary Outcome Measures

1. Mean IOP Change From Baseline at 9 AM [Baseline to Week 12 - at 9 AM]

   Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.

2. Mean IOP Change at 4 PM [Baseline to Week 12 - at 4 PM]

   Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• ≥18 years;

• IOP=16-30mmHg

• OH or OAG with visual filed abnormality:

1. ≥3 adjacent points in 24 degrees field on the same side of the horizontal meridian, that have p <5% on the prepapillary diameter plot, one of which must have p <1%,

2. Glaucoma Hemifield Test outside normal limits,

3. Corrected Pattern Standard Deviation with p <5%

Exclusion Criteria:

• Previous damage of anterior chamber angle;

• ocular inflammation or ocular surgery within the past 3 months; Best Corrected Visual Acuity (logMAR) <1.0;

• contact lens wearer;

• severe central field loss;

• uncontrolled cardiovascular, hepatic or renal disease;

• any medication within past 1 month.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Call Center	Fort Worth	Texas	United States	76134

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00763061
• Other Study ID Numbers: MS-06-02
• First Posted: Sep 30, 2008
• Last Update Posted: Mar 2, 2010
• Last Verified: Feb 1, 2010

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

Study Results

Participant Flow

Recruitment Details	111 patients were enrolled in this study at 4 hospitals
Pre-assignment Detail	Eligibility patients were washed out for up to 4 weeks before randomization

Arm/Group Title	Travoprost 0.004%	Timolol 0.5%
Arm/Group Description	Travoprost at 9 AM + Placebo & 9 PM	Timolol in each eye, twice daily at 9 AM & 9 PM
Period Title: Overall Study
STARTED	54	57
COMPLETED	49	44
NOT COMPLETED	5	13

Baseline Characteristics

Arm/Group Title	Travoprost 0.004%	Timolol 0.5%	Total
Arm/Group Description	Travoprost at 9 AM + Placebo & 9 PM	Timolol in each eye, twice daily at 9 AM & 9 PM	Total of all reporting groups
Overall Participants	54	57	111
Age (Count of Participants)
<=18 years	2 3.7%	1 1.8%	3 2.7%
Between 18 and 65 years	33 61.1%	31 54.4%	64 57.7%
>=65 years	19 35.2%	25 43.9%	44 39.6%
Sex: Female, Male (Count of Participants)
Female	22 40.7%	26 45.6%	48 43.2%
Male	32 59.3%	31 54.4%	63 56.8%

Outcome Measures

1. Primary Outcome

Title	Mean Intraocular Pressure (IOP) at 9 AM
Description	Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.
Time Frame	At Week 12 - At the 9 AM time point for the patient's worse eye.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Travoprost 0.004%	Timolol 0.5%
Arm/Group Description	Travoprost at 9 AM + Placebo & 9 PM	Timolol in each eye, twice daily at 9 AM & 9 PM
Measure Participants	49	44
Mean (Standard Deviation) [millimeters mercury (mmHg)]	16.3 (4.27)	18.1 (4.32)

2. Secondary Outcome

Title	Mean IOP Change From Baseline at 9 AM
Description	Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.
Time Frame	Baseline to Week 12 - at 9 AM

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Travoprost 0.004%	Timolol 0.5%
Arm/Group Description	Travoprost at 9 AM + Placebo & 9 PM	Timolol in each eye, twice daily at 9 AM & 9 PM
Measure Participants	49	44
Mean (Standard Deviation) [mmHg]	-5.1 (4.35)	-4.4 (4.35)

3. Primary Outcome

Title	Week 12 - Mean IOP At 4 PM
Description	Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.
Time Frame	At the 4 PM time point for the patient's worse eye.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Travoprost 0.004%	Timolol 0.5%
Arm/Group Description	Travoprost at 9 AM + Placebo & 9 PM	Timolol in each eye, twice daily at 9 AM & 9 PM
Measure Participants	49	44
Mean (Standard Deviation) [mmHg]	15.7 (3.16)	17.9 (4.02)

4. Secondary Outcome

Title	Mean IOP Change at 4 PM
Description	Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.
Time Frame	Baseline to Week 12 - at 4 PM

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Travoprost 0.004%	Timolol 0.5%
Arm/Group Description	Travoprost at 9 AM + Placebo & 9 PM	Timolol in each eye, twice daily at 9 AM & 9 PM
Measure Participants	49	44
Mean (Standard Deviation) [mmHg]	-5.3 (3.69)	-3.7 (4.15)

Adverse Events

Arm/Group Title	Travoprost 0.004%		Timolol 0.5%
Arm/Group Description	Travoprost at 9 AM + Placebo & 9 PM		Timolol in each eye, twice daily at 9 AM & 9 PM
All Cause Mortality
	Travoprost 0.004%		Timolol 0.5%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Travoprost 0.004%		Timolol 0.5%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/57 (0%)
Other (Not Including Serious) Adverse Events
	Travoprost 0.004%		Timolol 0.5%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/57 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.