Study of Travatan and Cosopt in Primary Open-Angle Glaucoma or Ocular Hypertension

• Sponsor: Alcon Research (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00471068
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

To compare the efficacy and safety in patients treated with travoprost versus dorzolamide/timolol maleate combination in patients with open-angle glaucoma or ocular hypertension

Condition or Disease	Intervention/Treatment	Phase
Open-angle Glaucoma; Ocular Hypertension	Drug: Travatan; Drug: Cosopt; Drug: Placebo (Timolol Vehicle)	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Study of Travatan and Cosopt in Primary Open-Angle Glaucoma or Ocular Hypertension
• Study Start Date: Mar 1, 2007
• Actual Primary Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Travatan Travatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)	Drug: Travatan; Travatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s); Drug: Placebo (Timolol Vehicle); Travatan group: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)
Active Comparator: Cosopt treatment period of 6 weeks with Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution) twice daily at 08:00 and 20:00 in the affected eye(s)	Drug: Cosopt; treatment period of 6 weeks with Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution) twice daily at 08:00 and 20:00 in the affected eye(s)

Outcome Measures

Primary Outcome Measures

1. Intaocular Pressure (IOP) Mean Change After 6 Weeks of Treatment [At week 0 and week 6]

   IOP measured at week 6 minus IOP measured at baseline

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Patient with open-angle glaucoma or ocular hypertension

Exclusion Criteria:

• By Age

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Coimbra	Coimbra		Portugal	3000354

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Anna Grau, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT00471068
• Other Study ID Numbers: EMD-05-03
• First Posted: May 9, 2007
• Last Update Posted: Apr 11, 2012
• Last Verified: Feb 1, 2010

• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Timolol; Travoprost

Study Results

Participant Flow

Recruitment Details	Recruitment period: from 13-03-2007 to 30-11-2007 Recruitment restarted on 27-03-2008 to 27-05-2008 First patient first visit: 19-03-2007 Last patient last visit: 29-05-2008
Pre-assignment Detail	After completing the run-in, 8 patients were not randomized: 7 patients did not meet entry criteria and 1 patient was excluded by sponsor's decision.

Arm/Group Title	Travatan	Cosopt
Arm/Group Description
Period Title: Overall Study
STARTED	21	25
COMPLETED	20	24
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Travatan	Cosopt	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	21	25	46
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	10 47.6%	16 64%	26 56.5%
>=65 years	11 52.4%	9 36%	20 43.5%
Sex: Female, Male (Count of Participants)
Female	14 66.7%	10 40%	24 52.2%
Male	7 33.3%	15 60%	22 47.8%

Outcome Measures

1. Primary Outcome

Title	Intaocular Pressure (IOP) Mean Change After 6 Weeks of Treatment
Description	IOP measured at week 6 minus IOP measured at baseline
Time Frame	At week 0 and week 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Travatan	Cosopt
Arm/Group Description
Measure Participants	21	25
Mean (Standard Deviation) [millimeters mercury (mm Hg)]	-4.57 (1.62)	-4.08 (2.50)

Adverse Events

Time Frame	Run-in (2-4 weeks) + treatment period (6 weeks)
Arm/Group Title	Travatan		Cosopt
Arm/Group Description
All Cause Mortality
	Travatan		Cosopt
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Travatan		Cosopt
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		1/25 (4%)
Surgical and medical procedures
Inguinal hernia surgery	0/21 (0%)	0	1/25 (4%)	1
Other (Not Including Serious) Adverse Events
	Travatan		Cosopt
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/21 (9.5%)		3/25 (12%)
Eye disorders
Ocular pruritus	1/21 (4.8%)	1	1/25 (4%)	1
Ocular discomfort	0/21 (0%)	0	1/25 (4%)	1
Redness eye	1/21 (4.8%)	1	0/25 (0%)	0
Infections and infestations
Flu	0/21 (0%)	0	1/25 (4%)	1

Limitations/Caveats

Sample size smaller than the one defined by the protocol

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.