Aqueous Humor Concentration of InSite Vision (ISV) 303 (Bromfenac in DuraSite) to Bromday Once Daily (QD) Prior to Cataract Surgery

• Sponsor: Sun Pharmaceutical Industries Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01387464
• Collaborator: (none)
• Enrollment: 60
• Arms: 2
• Duration (Months): 1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the aqueous humor concentration of bromfenac sodium in subjects administered multiple topical ocular doses of ISV-303 or Bromday™ QD prior to routine cataract surgery.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Drug: ISV-303; Drug: Bromday™	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Double-Masked Clinical Study To Determine The Aqueous Humor Concentration Of Bromfenac Sodium In Subjects Administered Multiple Topical Ocular Doses Of ISV-303 Or Bromday™ Once Daily (QD) Prior To Cataract Surgery
• Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ISV-303	Drug: ISV-303; 0.075% bromfenac in DuraSite dosed QD
Active Comparator: Bromday™	Drug: Bromday™; 0.09% bromfenac dosed QD

Outcome Measures

Primary Outcome Measures

1. Mean Aqueous Humor Bromfenac Concentration [Approximately 3 hours post last dose]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Male or female subjects age 18 or older scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation

• If a female is of childbearing potential, the subject must agree to and submit a urine sample for pregnancy testing at Visit 1 prior to enrollment and at the end of the study, and the subject must use effective contraception for the duration of the study. Post menopausal is defined as having no menses for at least 12 consecutive months.

• Signature of the subject on the Informed Consent Form

• Willing and able to follow all instructions and attend all study visits

• Able to self-administer study drug (or have a caregiver available to instill all doses of study drug)

Exclusion Criteria:

• Use of any drug containing bromfenac within 2 weeks prior to surgery

• Contact lens wear during the dosing period

• Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the investigational medicinal product (IMP) or any of the procedural medications

• Any serious complications with or macroscopic damage to the corneal epithelium

• Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive urine pregnancy test

• Currently suffer from alcohol and/or drug abuse

• Prior participation in this study protocol

• Prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device

• A condition or a situation, which in the investigator's opinion may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation

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: NCT01387464
• Other Study ID Numbers: C-11-303-002
• First Posted: Jul 4, 2011
• Last Update Posted: Nov 19, 2021
• Last Verified: Nov 1, 2021

• Keywords provided by Sun Pharmaceutical Industries Limited: bromfenac concentrations; ISV-303; Bromday
• Additional relevant MeSH terms: Cataract; Bromfenac

Study Results

Participant Flow

Arm/Group Title	ISV-303	Bromday
Arm/Group Description	0.075% bromfenac in DuraSite vehicle dosed QD	0.09% bromfenac dosed QD
Period Title: Overall Study
STARTED	30	30
Safety Population	30	29
Per-Protocol Population	29	29
COMPLETED	29	29
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	ISV-303	Bromday	Total
Arm/Group Description	0.075% bromfenac in DuraSite vehicle dosed QD	0.09% bromfenac dosed QD	Total of all reporting groups
Overall Participants	30	30	60
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.6 (10.14)	68.2 (9.5)	69.4 (9.8)
Age, Customized (participants) [Number]
18-30 years	0 0%	0 0%	0 0%
31-50 years	1 3.3%	0 0%	1 1.7%
51-70 years	10 33.3%	18 60%	28 46.7%
>70 years	19 63.3%	12 40%	31 51.7%
Sex: Female, Male (Count of Participants)
Female	12 40%	19 63.3%	31 51.7%
Male	18 60%	11 36.7%	29 48.3%

Outcome Measures

1. Primary Outcome

Title	Mean Aqueous Humor Bromfenac Concentration
Time Frame	Approximately 3 hours post last dose

Outcome Measure Data

Analysis Population Description

Per-Protocol Population

Arm/Group Title	ISV-303	Bromday
Arm/Group Description	0.075% bromfenac in DuraSite vehicle dosed QD	0.09% bromfenac dosed QD
Measure Participants	29	29
Mean (Standard Deviation) [ng/mL]	49.3 (41.87)	23.7 (16.31)

Adverse Events

Time Frame	4 days
Arm/Group Title	ISV-303		Bromday
Arm/Group Description	0.075% bromfenac in DuraSite vehicle dosed QD		0.09% bromfenac dosed QD
All Cause Mortality
	ISV-303		Bromday
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	ISV-303		Bromday
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/29 (0%)
Other (Not Including Serious) Adverse Events
	ISV-303		Bromday
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/29 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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