Prospective Study With Adjunctive Once Daily Topical Nepafenac 0.3% Versus Placebo

• Sponsor: Intuor Technologies, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03025945
• Collaborator: (none)
• Enrollment: 662
• Arms: 2
• Duration (Months): 39

Study Details

Study Description

Brief Summary

Prospective, randomized, double-masked, placebo-controlled clinical study to define the effective use of a topical non-steroidal anti-inflammatory drug added to topical steroid use after uncomplicated phacoemulsification for the prevention of pseudophakic cystoid macular edema.

Condition or Disease	Intervention/Treatment	Phase
Cystoid Macular Edema	Drug: Nepafenac 0.3%; Drug: Saline Solution	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 662 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Pseudophakic Cystoid Macular Edema Prevention and Risk Factors; Prospective Study With Adjunctive Once Daily Topical Nepafenac 0.3% Versus Placebo
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: nepafenac 0.3% nepafenac 0.3% ophthalmic solution dosed once daily	Drug: Nepafenac 0.3%
Placebo Comparator: Saline Solution sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily	Drug: Saline Solution

Outcome Measures

Primary Outcome Measures

1. Post-operative Clinical Findings of Cystoid Macular Edema [6 weeks]

   post-operative macular volume (mm)

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Subjects, 18 and older subjects with visually significant cataracts and were to undergo phacoemulsification with implantation of an intracapsular positioned intraocular lens.

Exclusion Criteria:

• previous uveitis (<1 year) previous anterior segment intraocular surgery hypersensitivity or allergy to NSAIDs

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Intuor Technologies, Inc.

Investigators

• Principal Investigator: Sean McCafferty, MD, Arizona Eye Consultants

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Intuor Technologies, Inc.
• ClinicalTrials.gov Identifier: NCT03025945
• Other Study ID Numbers: CME and nepafenac 0.3%
• First Posted: Jan 20, 2017
• Last Update Posted: Dec 14, 2018
• Last Verified: Dec 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Macular Edema; Nepafenac

Study Results

Participant Flow

Arm/Group Title	Nepafenac 0.3%	Saline Solution
Arm/Group Description	nepafenac 0.3% ophthalmic solution dosed once daily Nepafenac 0.3%	sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily Saline Solution
Period Title: Overall Study
STARTED	331	331
COMPLETED	331	331
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Nepafenac 0.3%	Saline Solution	Total
Arm/Group Description	nepafenac 0.3% ophthalmic solution dosed once daily Nepafenac 0.3%	sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily Saline Solution	Total of all reporting groups
Overall Participants	331	331	662
Overall Eyes	500	500	1000
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	68.8	67.9	68.3
Sex: Female, Male (Count of Participants)
Female	182 55%	182 55%	364 55%
Male	149 45%	149 45%	298 45%
Macular volume (mm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm]	8.7 (0.15)	8.75 (0.15)	8.72 (0.15)

Outcome Measures

1. Primary Outcome

Title	Post-operative Clinical Findings of Cystoid Macular Edema
Description	post-operative macular volume (mm)
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nepafenac 0.3%	Saline Solution
Arm/Group Description	nepafenac 0.3% ophthalmic solution dosed once daily Nepafenac 0.3%	sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily Saline Solution
Measure Participants	331	331
Measure Eyes	500	500
Mean (Standard Deviation) [mm]	8.85 (0.13)	8.95 (0.18)

Adverse Events

Time Frame	3 weeks
Adverse Event Reporting Description	Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Arm/Group Title	Nepafenac 0.3%		Saline Solution
Arm/Group Description	nepafenac 0.3% ophthalmic solution dosed once daily Nepafenac 0.3%		sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily Saline Solution
All Cause Mortality
	Nepafenac 0.3%		Saline Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Nepafenac 0.3%		Saline Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/331 (0%)		0/331 (0%)
Other (Not Including Serious) Adverse Events
	Nepafenac 0.3%		Saline Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/331 (0.3%)		0/331 (0%)
Eye disorders
drop intolerance	1/331 (0.3%)	1	0/331 (0%)	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.