Safety and Efficacy of a Drug Delivery System in Glaucoma

• Sponsor: Vistakon Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01016691
• Collaborator: (none)
• Enrollment: 47
• Locations: 5
• Arms: 3
• Patients Per Site: 9.4

Study Details

Study Description

Brief Summary

Evaluation of the ocular safety and efficacy of a drug delivery system in open-angle glaucoma or ocular hypertension.

Condition or Disease	Intervention/Treatment	Phase
Open-angle Glaucoma; Ocular Hypertension	Drug: High Dose Drug Device; Drug: Low Dose Drug Device; Drug: Placebo Device; Drug: bimatoprost 0.03%	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High Dose Drug Device/ bimatoprost 0.03% drug device containing 65 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).	Drug: High Dose Drug Device; device inserted for 4 days; Drug: bimatoprost 0.03%; one drop in each eye on one day only
Experimental: Low Dose Drug Device / bimatoprost 0.03% drug device containing 45 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).	Drug: Low Dose Drug Device; device inserted for 4 days; Drug: bimatoprost 0.03%; one drop in each eye on one day only
Other: Placebo Device / bimatoprost 0.03% placebo drug device worn over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).	Drug: Placebo Device; device inserted for 4 days; Drug: bimatoprost 0.03%; one drop in each eye on one day only

Outcome Measures

Primary Outcome Measures

1. Mean Change in Intraocular Pressure at Day 1 [Baseline to Day 1]

Secondary Outcome Measures

1. Mean Change in Intraocular Pressure at Day 2 [Baseline to Day 2]

2. Mean Change in Intraocular Pressure at Day 3 [Baseline to Day 3]

3. Mean Change in Intraocular Pressure at Day 4 [Baseline to Day 4]

4. Mean Change in Intraocular Pressure at Day 5 [Day 4 to Day 5]

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

• 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		Miami	Florida	United States
2		Philadelphia	Pennsylvania	United States
3		Mount Pleasant	South Carolina	United States
4		Rapid City	South Dakota	United States
5		Maryville	Tennessee	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: NCT01016691
• Other Study ID Numbers: CR-1649
• First Posted: Nov 19, 2009
• Last Update Posted: Mar 6, 2015
• Last Verified: Feb 1, 2015

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

Study Results

Participant Flow

Arm/Group Title	High Dose Drug Device/ Bimatoprost 0.03%	Low Dose Drug Device / Bimatoprost 0.03%	Placebo Device / Bimatoprost 0.03%
Arm/Group Description	high dose drug device during first period, bimatoprost 0.03% during second period.	low-dose drug device during first period, bimatoprost 0.03% during second period.	placebo device during first period, bimatoprost 0.03% during second period.
Period Title: Overall Study
STARTED	17	12	18
COMPLETED	17	12	18
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	High Dose Drug Device/ Bimatoprost 0.03%	Low Dose Drug Device / Bimatoprost 0.03%	Placebo Device / Bimatoprost 0.03%	Total
Arm/Group Description	high dose drug device during first period, bimatoprost 0.03% during second period.	low-dose drug device during first period, bimatoprost 0.03% during second period.	placebo device during first period, bimatoprost 0.03% during second period.	Total of all reporting groups
Overall Participants	17	12	18	47
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.8 (9.78)	66.3 (11.37)	63.1 (9.07)	63.4 (8.68)
Sex: Female, Male (Count of Participants)
Female	12 70.6%	8 66.7%	10 55.6%	30 63.8%
Male	5 29.4%	4 33.3%	8 44.4%	17 36.2%
Region of Enrollment (participants) [Number]
United States	17 100%	12 100%	18 100%	47 100%

Outcome Measures

1. Primary Outcome

Title	Mean Change in Intraocular Pressure at Day 1
Time Frame	Baseline to Day 1

Outcome Measure Data

Analysis Population Description

per-protocol population

Arm/Group Title	High Dose Drug Device/ Bimatoprost 0.03%	Low Dose Drug Device / Bimatoprost 0.03%	Placebo Device / Bimatoprost 0.03%
Arm/Group Description	high dose drug device during first period, bimatoprost 0.03% during second period.	low-dose drug device during first period, bimatoprost 0.03% during second period.	placebo device during first period, bimatoprost 0.03% during second period.
Measure Participants	14	11	15
Mean (Standard Deviation) [mmHg]	-4.16 (3.409)	-4.57 (3.645)	-0.60 (2.331)

2. Secondary Outcome

Title	Mean Change in Intraocular Pressure at Day 2
Time Frame	Baseline to Day 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Mean Change in Intraocular Pressure at Day 3
Time Frame	Baseline to Day 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Mean Change in Intraocular Pressure at Day 4
Time Frame	Baseline to Day 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Mean Change in Intraocular Pressure at Day 5
Time Frame	Day 4 to Day 5

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	High Dose Drug Device/ Bimatoprost 0.03%		Low Dose Drug Device / Bimatoprost 0.03%		Placebo Device / Bimatoprost 0.03%
Arm/Group Description	high dose drug device during first period, bimatoprost 0.03% during second period.		low-dose drug device during first period, bimatoprost 0.03% during second period.		placebo device during first period, bimatoprost 0.03% during second period.
All Cause Mortality
	High Dose Drug Device/ Bimatoprost 0.03%		Low Dose Drug Device / Bimatoprost 0.03%		Placebo Device / Bimatoprost 0.03%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	High Dose Drug Device/ Bimatoprost 0.03%		Low Dose Drug Device / Bimatoprost 0.03%		Placebo Device / Bimatoprost 0.03%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/12 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	High Dose Drug Device/ Bimatoprost 0.03%		Low Dose Drug Device / Bimatoprost 0.03%		Placebo Device / Bimatoprost 0.03%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/17 (70.6%)		7/12 (58.3%)		8/18 (44.4%)
Eye disorders
Conjunctival Hyperemia	5/17 (29.4%)	5	4/12 (33.3%)	4	5/18 (27.8%)	5
Eye Irritation	0/17 (0%)	0	2/12 (16.7%)	2	0/18 (0%)	0
Eye Pain	0/17 (0%)	0	0/12 (0%)	0	1/18 (5.6%)	1
Eye Pruritus	2/17 (11.8%)	2	1/12 (8.3%)	1	0/18 (0%)	0
Eyelid Pruritus	0/17 (0%)	0	2/12 (16.7%)	2	0/18 (0%)	0
Eyelid Margin Crusting	0/17 (0%)	0	0/12 (0%)	0	1/18 (5.6%)	1
Eyelid Oedema	1/17 (5.9%)	1	0/12 (0%)	0	1/18 (5.6%)	1
Foreign Body Sensation in Eye	1/17 (5.9%)	1	1/12 (8.3%)	2	0/18 (0%)	0
Punctate Keratitis	0/17 (0%)	0	1/12 (8.3%)	2	0/18 (0%)	0
Ocular Hyperemia	0/17 (0%)	0	0/12 (0%)	0	1/18 (5.6%)	1
Lid Margin Discharge	0/17 (0%)	0	0/12 (0%)	0	1/18 (5.6%)	1
Abnormal Sensation in Eye	1/17 (5.9%)	1	0/12 (0%)	0	0/18 (0%)	0
Eye Disorder	0/17 (0%)	0	0/12 (0%)	0	1/18 (5.6%)	1
Gastrointestinal disorders
Gingivitis	0/17 (0%)	0	0/12 (0%)	0	1/18 (5.6%)	1
Injury, poisoning and procedural complications
Medical Device Complication	3/17 (17.6%)	3	1/12 (8.3%)	1	3/18 (16.7%)	3
Medical Device Discomfort	1/17 (5.9%)	1	1/12 (8.3%)	1	0/18 (0%)	0
Procedural Pain	1/17 (5.9%)	1	1/12 (8.3%)	1	0/18 (0%)	0
Musculoskeletal and connective tissue disorders
Muscle Spasms	0/17 (0%)	0	1/12 (8.3%)	1	0/18 (0%)	0
Nervous system disorders
Headache	0/17 (0%)	0	0/0 (NaN)	0	2/18 (11.1%)	2
Respiratory, thoracic and mediastinal disorders
Nasal Congestion	1/17 (5.9%)	1	0/12 (0%)	0	0/18 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Publication requires written consent of the sponsor.