Safety and Efficacy of a Glaucoma Drug Delivery System

• Sponsor: Vistakon Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00824720
• Collaborator: (none)
• Enrollment: 55
• Locations: 4
• Arms: 3
• Duration (Months): 4
• Patients Per Site: 13.8
• Patients Per Site Per Month: 3.5

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the ocular safety and efficacy of a glaucoma drug delivery system in open-angle glaucoma or ocular hypertension.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Open-Angle; Ocular Hypertension	Drug: High Dose Device; Drug: Low Dose Device; Device: Placebo Device	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Dec 1, 2008
• Actual Primary Completion Date: Apr 1, 2009
• Actual Study Completion Date: Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High Dose Device device worn continuously for 14 days	Drug: High Dose Device; inserted for 14 days
Experimental: Low Dose Device device worn continuously for 14 days	Drug: Low Dose Device; inserted for 14 days
Placebo Comparator: Placebo Device device worn continuously for 14 days	Device: Placebo Device; inserted for 14 days

Outcome Measures

Primary Outcome Measures

1. Visual Acuity - Right Eye [at 14 days]

   This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR). The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.

2. Visual Acuity - Left Eye [at 14 days]

   This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR. The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.

Secondary Outcome Measures

1. Intraocular Pressure (IOP) [from baseline to 14 days]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Man or woman 21 years of age or greater

• must have open angle glaucoma or ocular hypertension.

• Corrected visual acuity in each eye of 20/200 or better.

Exclusion Criteria:

• Previous glaucoma intraocular surgery or refractive surgery.

• Planned contact lens use during the study.

• Clinically significant ocular or systemic disease that might interfere with the study.

• Use of chronic corticosteroids by any route.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Artesia	California	United States
2		Louisville	Kentucky	United States
3		Baltimore	Maryland	United States	USA
4		Mount Pleasant	South Carolina	United States

Sponsors and Collaborators

• Vistakon Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vistakon Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00824720
• Other Study ID Numbers: CR-1630
• First Posted: Jan 19, 2009
• Last Update Posted: Mar 6, 2015
• Last Verified: Feb 1, 2015

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

Study Results

Participant Flow

Arm/Group Title	High Dose Bimatoprost Punctal Plug	Low Dose Bimatoprost Punctal Plug	Placebo
Arm/Group Description	punctal plug with bimatoprost, high dose	punctal plug with bimatoprost, low dose	punctal plug without bimatoprost
Period Title: Overall Study
STARTED	19	16	20
COMPLETED	16	15	19
NOT COMPLETED	3	1	1

Baseline Characteristics

Arm/Group Title	High Dose Bimatoprost Punctal Plug	Low Dose Bimatoprost Punctal Plug	Placebo	Total
Arm/Group Description	punctal plug with bimatoprost, high dose	punctal plug with bimatoprost, low dose	punctal plug without bimatoprost	Total of all reporting groups
Overall Participants	16	15	20	51
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.7 (13.4)	64.6 (12.9)	64.5 (10.6)	65.2 (12.0)
Sex: Female, Male (Count of Participants)
Female	9 56.3%	9 60%	13 65%	31 60.8%
Male	7 43.8%	6 40%	7 35%	20 39.2%

Outcome Measures

1. Secondary Outcome

Title	Intraocular Pressure (IOP)
Time Frame	from baseline to 14 days

Outcome Measure Data

Analysis Population Description

The analysis population includes all subjects with a plug insertion that completed the study per protocol.

Arm/Group Title	High Dose Bimatoprost Punctal Plug	Low Dose Bimatoprost Punctal Plug	Placebo
Arm/Group Description	punctal plug with bimatoprost, high dose	punctal plug with bimatoprost, low dose	punctal plug without bimatoprost
Measure Participants	14	15	19
Mean (Standard Deviation) [mmHg]	-1.9 (2.3)	-2.2 (3.5)	-1.3 (3.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	High Dose Bimatoprost Punctal Plug, Placebo
	Comments	The alternative hypothesis was that the high dose was different from the placebo.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9737
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	least square mean difference
	Estimated Value	-0.22
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Standard Deviation; Value: 2.3
	Estimation Comments	Mean difference was calculated as high dose minus placebo.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Low Dose Bimatoprost Punctal Plug, Placebo
	Comments	The alternative hypothesis is that the low dose was different from placebo.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4711
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	least square mean difference
	Estimated Value	-1.11
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Standard Deviation; Value: 3.5
	Estimation Comments	The mean difference was calculated as low dose minus placebo.

2. Primary Outcome

Title	Visual Acuity - Right Eye
Description	This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR). The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Time Frame	at 14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Dose Bimatoprost Punctal Plug	Low Dose Bimatoprost Punctal Plug	Placebo
Arm/Group Description	punctal plug with bimatoprost, high dose	punctal plug with bimatoprost, low dose	punctal plug without bimatoprost
Measure Participants	14	15	19
Mean (Standard Deviation) [logMAR units]	0.015 (0.046)	-0.044 (0.092)	-0.012 (0.044)

3. Primary Outcome

Title	Visual Acuity - Left Eye
Description	This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR. The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Time Frame	at 14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Dose Bimatoprost Punctal Plug	Low Dose Bimatoprost Punctal Plug	Placebo
Arm/Group Description	punctal plug with bimatoprost, high dose	punctal plug with bimatoprost, low dose	punctal plug without bimatoprost
Measure Participants	14	15	19
Mean (Standard Deviation) [logMARs]	-0.011 (0.081)	-0.008 (0.101)	-0.019 (0.044)

Adverse Events

Arm/Group Title	High Dose Bimatoprost Punctal Plug		Low Dose Bimatoprost Punctal Plug		Placebo
Arm/Group Description	punctal plug with bimatoprost, high dose		punctal plug with bimatoprost, low dose		punctal plug without bimatoprost
All Cause Mortality
	High Dose Bimatoprost Punctal Plug		Low Dose Bimatoprost Punctal Plug		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	High Dose Bimatoprost Punctal Plug		Low Dose Bimatoprost Punctal Plug		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/16 (6.3%)		0/15 (0%)		0/20 (0%)
Nervous system disorders
cerebrovascular accident	1/16 (6.3%)		0/15 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	High Dose Bimatoprost Punctal Plug		Low Dose Bimatoprost Punctal Plug		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/16 (81.3%)		11/15 (73.3%)		11/20 (55%)
Eye disorders
Foreign body sensation	8/16 (50%)		5/15 (33.3%)		3/20 (15%)
Eye pain	6/16 (37.5%)		2/15 (13.3%)		1/20 (5%)
abnormal sensation in eyes	5/16 (31.3%)		3/15 (20%)		4/20 (20%)
Conjunctival hyperaemia	3/16 (18.8%)		5/15 (33.3%)		2/20 (10%)
corneal erosion	5/16 (31.3%)		2/15 (13.3%)		0/20 (0%)
dry eye	3/16 (18.8%)		2/15 (13.3%)		0/20 (0%)
erythema of eyelid	1/16 (6.3%)		0/15 (0%)		0/20 (0%)
eye irritation	1/16 (6.3%)		0/15 (0%)		0/20 (0%)
eye puritus	0/16 (0%)		0/15 (0%)		1/20 (5%)
eyelid margin crusting	4/16 (25%)		1/15 (6.7%)		2/20 (10%)
eyelid pain	5/16 (31.3%)		2/15 (13.3%)		1/20 (5%)
eyelids puritus	0/16 (0%)		0/15 (0%)		1/20 (5%)
inflammation of lacrimal passage	5/16 (31.3%)		4/15 (26.7%)		2/20 (10%)
lacrimation increased	2/16 (12.5%)		5/15 (33.3%)		4/20 (20%)
ocular hyperaemia	3/16 (18.8%)		2/15 (13.3%)		0/20 (0%)
visual acuity reduced	0/16 (0%)		0/15 (0%)		1/20 (5%)
Infections and infestations
upper respiratory tract infection	0/16 (0%)		1/15 (6.7%)		0/20 (0%)
Injury, poisoning and procedural complications
contusion	0/16 (0%)		1/15 (6.7%)		0/20 (0%)
procedural complication	1/16 (6.3%)		0/15 (0%)		2/20 (10%)
Musculoskeletal and connective tissue disorders
musculoskeletal chest pain	0/16 (0%)		0/15 (0%)		1/20 (5%)
Nervous system disorders
sinus headache	0/16 (0%)		0/15 (0%)		1/20 (5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Prior to submission for publication or presentation, the PI will provide the Sponsor 60 days for review of the manuscript. The Sponsor may request that the PI withhold the publication for an additional 60 days.