Travoprost 0.004% Versus Pilocarpine 1% in Patients With Chronic Angle Closure Glaucoma (CACG)

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00762645
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

The purpose of this study is to demonstrate that the Intraocular Pressure (IOP) lowering efficacy of Travoprost Ophthalmic Solution 0.004% is superior to that of Pilocarpine 1% in patients with chronic angle-closure glaucoma (CACG).

Condition or Disease	Intervention/Treatment	Phase
Angle-Closure Glaucoma	Drug: Travoprost 0.004% (Travatan); Drug: Pilocarpine 1%	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Twelve-Week, Double Masked, Parallel Group, Primary-Therapy Pilot Study of the Safety and Efficacy of Travoprost 0.004% Compared to Pilocarpine 1% in Patients With Chronic Angle-Closure Glaucoma
• Study Start Date: Feb 1, 2007
• Actual Primary Completion Date: May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Travoprost 0.004% (Travatan) One drop in each eye, once daily at 9 AM	Drug: Travoprost 0.004% (Travatan); One drop in each eye, once daily at 9 AM
Active Comparator: Pilocarpine 1% One drop in each eye, forth times daily at 7 AM, 11 AM , 4 PM and 9 PM for twelve (12) weeks	Drug: Pilocarpine 1%; One drop in each eye, forth times daily at 7 AM, 11 AM , 4 PM and 9 PM for twelve (12) weeks

Outcome Measures

Primary Outcome Measures

1. Mean Intraocular Pressure (IOP) [4PM at Week 12 Visit]

Secondary Outcome Measures

1. Number of Patients With Peripheral Anterior Synechiae (PAS) [Week 12 Visit]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Age ≥ 18 years

• Chronic Angle Closure Glaucoma (CACG)

• 21-35 millimeters mercury mean intraocular pressure on Eligibility visit day at 9 AM

• Peripheral iridotomy performed ≥ 1 Month prior to the Screening visit

• Anterior chamber angle in which the trabecular meshwork is not visible for ≥180 degrees in gonioscopy without indentation

• Peripheral anterior synechiae (PAS)

Exclusion Criteria:

• Traumatic damage of the anterior chamber angle

• History of ocular inflammation or surgery (except for iridotomy) ≤ 3 months

• Patients who cannot be safely discontinued from use of all ocular hypotensive medication(s) for 12 days to 14 weeks

• Visual Acuity ≥ 1.0

• Contact lenses wearer

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: NCT00762645
• Other Study ID Numbers: CM-06-04
• First Posted: Sep 30, 2008
• Last Update Posted: Mar 16, 2010
• Last Verified: Mar 1, 2010

• Keywords provided by , ,: IOP lowering efficacy; CACG
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Angle-Closure; Travoprost; Pilocarpine

Study Results

Participant Flow

Recruitment Details	30 patients were enrolled in this study
Pre-assignment Detail	Patients randomized at 1:1 ratio into two treatment groups

Arm/Group Title	Travoprost 0.004% (Travatan)	Pilocarpine 1%
Arm/Group Description	Travoprost 0.004% Ophthalmic Solution	Pilocarpine 1% Ophthalmic Solution
Period Title: Overall Study
STARTED	16	14
COMPLETED	12	12
NOT COMPLETED	4	2

Baseline Characteristics

Arm/Group Title	Travoprost 0.004% (Travatan)	Pilocarpine 1%	Total
Arm/Group Description	Travoprost 0.004% Ophthalmic Solution	Pilocarpine 1% Ophthalmic Solution	Total of all reporting groups
Overall Participants	16	14	30
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	2 12.5%	3 21.4%	5 16.7%
>=65 years	14 87.5%	11 78.6%	25 83.3%
Sex: Female, Male (Count of Participants)
Female	9 56.3%	6 42.9%	15 50%
Male	7 43.8%	8 57.1%	15 50%

Outcome Measures

1. Primary Outcome

Title	Mean Intraocular Pressure (IOP)
Time Frame	4PM at Week 12 Visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Travoprost 0.004% (Travatan)	Pilocarpine 1%
Arm/Group Description	Travoprost 0.004% Ophthalmic Solution	Pilocarpine 1% Ophthalmic Solution
Measure Participants	16	14
Mean (Standard Deviation) [millimeters mercury (mm Hg)]	15.77 (2.32)	18.35 (3.72)

2. Secondary Outcome

Title	Number of Patients With Peripheral Anterior Synechiae (PAS)
Time Frame	Week 12 Visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Travoprost 0.004% (Travatan)	Pilocarpine 1%
Arm/Group Description	Travoprost 0.004% Ophthalmic Solution	Pilocarpine 1% Ophthalmic Solution
Measure Participants	16	14
Number [Participants]	0 0%	0 0%

Adverse Events

Arm/Group Title	Travoprost 0.004% (Travatan)		Pilocarpine 1%
Arm/Group Description	Travoprost 0.004% Ophthalmic Solution		Pilocarpine 1% Ophthalmic Solution
All Cause Mortality
	Travoprost 0.004% (Travatan)		Pilocarpine 1%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Travoprost 0.004% (Travatan)		Pilocarpine 1%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Travoprost 0.004% (Travatan)		Pilocarpine 1%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/14 (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.