Study to Compare Differing Dosing Regimens of ISV-303 (Bromfenac in DuraSite) to Xibrom and Vehicle in Post Cataract Surgery Volunteers

• Sponsor: Sun Pharmaceutical Industries Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01190878
• Collaborator: (none)
• Enrollment: 169
• Arms: 4
• Duration (Months): 5

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy in topical administration of differing dosing regimens of ISV-303 compared to vehicle and Xibrom™ when dosed for 2 weeks in post-cataract-surgery volunteers.

Condition or Disease	Intervention/Treatment	Phase
Ocular Inflammation	Drug: ISV-303; Drug: ISV-303; Drug: DuraSite Vehicle; Drug: Xibrom™	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 169 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Double-masked 14-day Study to Compare the Ocular Safety, Tolerability, and Efficacy of Differing Dosing Regimens of ISV-303 to Vehicle and Xibrom™ in Post Cataract Surgery Volunteers
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ISV-303 BID	Drug: ISV-303; 0.075% of bromfenac in DuraSite dosed BID
Experimental: ISV-303 QD	Drug: ISV-303; 0.075% of bromfenac in DuraSite dosed QD
Active Comparator: Xibrom BID	Drug: Xibrom™; 0.09% bromfenac dosed BID
Placebo Comparator: DuraSite Vehicle BID	Drug: DuraSite Vehicle; Vehicle dosed BID

Outcome Measures

Primary Outcome Measures

1. Ocular Inflammation [15 days]

   Anterior Chamber Cell Grade 0 at Day 15 measured on a 0 to 4 scale: "0" is 0 cells; "1" is 1-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is > 50 cells.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation on the day prior to study enrollment

• Meet the best corrected visual acuity score requirement

• Meet the IOP requirement

• Additional inclusion criteria also apply

Exclusion Criteria:

• Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the study medications or any of the procedural medications

• Use of any ocular topical, or systemic medication that could interfere with normal lacrimation, wound healing, the test agent, or the interpretation of study results, within 1 week prior to Day of Surgery

• Additional exclusion criteria also apply

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Sun Pharmaceutical Industries Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sun Pharmaceutical Industries Limited
• ClinicalTrials.gov Identifier: NCT01190878
• Other Study ID Numbers: C-10-303-001
• First Posted: Aug 30, 2010
• Last Update Posted: Nov 19, 2021
• Last Verified: Nov 1, 2021

• Additional relevant MeSH terms: Cataract; Inflammation; Bromfenac

Study Results

Participant Flow

Arm/Group Title	ISV-303 BID	ISV-303 QD	Xibrom BID	DuraSite Vehicle BID
Arm/Group Description	ISV-303: 0.075% bromfenac in DuraSite dosed BID	ISV-303: 0.075% bromfenac in DuraSite dosed QD	Xibrom™: 0.09% bromfenac dosed BID	DuraSite Vehicle: Vehicle dosed BID
Period Title: Overall Study
STARTED	40	45	42	42
COMPLETED	37	42	37	22
NOT COMPLETED	3	3	5	20

Baseline Characteristics

Arm/Group Title	ISV-303 BID	ISV-303 QD	Xibrom BID	DuraSite Vehicle BID	Total
Arm/Group Description	ISV-303: 0.075% of Bromfenac in DuraSite Dosed BID	ISV-303: 0.075% of Bromfenac in DuraSite Dosed QD	Xibrom™: Xibrom dosed BID	DuraSite Vehicle: Vehicle Dosed BID	Total of all reporting groups
Overall Participants	40	45	42	42	169
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71.3 (7.70)	70.9 (9.75)	68.6 (10.49)	67.0 (9.30)	69.5 (9.47)
Age, Customized (participants) [Number]
18-30 years	0 0%	0 0%	1 2.4%	0 0%	1 0.6%
31-50 years	0 0%	0 0%	0 0%	2 4.8%	2 1.2%
51-70 years	22 55%	22 48.9%	22 52.4%	25 59.5%	91 53.8%
>70 years	18 45%	23 51.1%	19 45.2%	15 35.7%	75 44.4%
Sex: Female, Male (Count of Participants)
Female	24 60%	21 46.7%	20 47.6%	24 57.1%	89 52.7%
Male	16 40%	24 53.3%	22 52.4%	18 42.9%	80 47.3%

Outcome Measures

1. Primary Outcome

Title	Ocular Inflammation
Description	Anterior Chamber Cell Grade 0 at Day 15 measured on a 0 to 4 scale: "0" is 0 cells; "1" is 1-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is > 50 cells.
Time Frame	15 days

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) Population using Last Observation Carried Forward (LOCF) method.

Arm/Group Title	ISV-303 BID	ISV-303 QD	Xibrom BID	DuraSite Vehicle BID
Arm/Group Description	ISV-303: 0.075% of Bromfenac in DuraSite Dosed BID	ISV-303: 0.075% of Bromfenac in DuraSite Dosed QD	Xibrom™: Xibrom dosed BID	DuraSite Vehicle: Vehicle Dosed BID
Measure Participants	40	45	42	42
Number [participants]	21 52.5%	24 53.3%	18 42.9%	8 19%

Adverse Events

Time Frame	29 days
Arm/Group Title	ISV-303 BID		ISV-303 QD		Xibrom BID		DuraSite Vehicle BID
Arm/Group Description	ISV-303: 0.075% of Bromfenac in DuraSite Dosed BID		ISV-303: 0.075% of Bromfenac in DuraSite Dosed QD		Xibrom™: Xibrom dosed BID		DuraSite Vehicle: Vehicle Dosed BID
All Cause Mortality
	ISV-303 BID		ISV-303 QD		Xibrom BID		DuraSite Vehicle BID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	ISV-303 BID		ISV-303 QD		Xibrom BID		DuraSite Vehicle BID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/40 (2.5%)		0/45 (0%)		1/42 (2.4%)		0/42 (0%)
Gastrointestinal disorders
Faecaloma	1/40 (2.5%)		0/45 (0%)		0/42 (0%)		0/42 (0%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	0/40 (0%)		0/45 (0%)		1/42 (2.4%)		0/42 (0%)
Other (Not Including Serious) Adverse Events
	ISV-303 BID		ISV-303 QD		Xibrom BID		DuraSite Vehicle BID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		4/45 (8.9%)		1/42 (2.4%)		1/42 (2.4%)
Eye disorders
Iritis	0/40 (0%)		4/45 (8.9%)		1/42 (2.4%)		1/42 (2.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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