Comparison of Diclofenac vs. Nepafenac Ophthalmic Drops: Patient Comfort

• Sponsor: Wolfson Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02506348
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1

Study Details

Study Description

Brief Summary

In this study we test Diclofenac and Nepafenac and compared patients experience and comfort following administration of these ophthalmic drops.

Condition or Disease	Intervention/Treatment	Phase
Post Surgical Management; Pain Management; Inflamation Management	Drug: Diclofenac; Drug: Nepafenac	N/A

Detailed Description

In this study we will compare the ocular tolerability between preservative-free Diclofenac and Nepafenac drops. Using a standard comparative scale we will measured discomfort, itching, burning and pain in intervals of 1 sec, 5 sec, 1 min and 5 min post-administration.

The results may aid both doctors and patients in decision regarding the post surgical anti-inflammatory treatment.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Study Start Date: Jul 1, 2015
• Anticipated Primary Completion Date: Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Diclofenac+Nepafenac one drop Diclofenac in one eye one drop Nepafenac in other eye	Drug: Diclofenac; Drug: Nepafenac

Outcome Measures

Primary Outcome Measures

1. patient's comfort [1 min post administration]

   change in patient's comfort between both eyes at 1 min post administration

Secondary Outcome Measures

1. patient's comfort [5 min post administration]

   change in patient's comfort between both eyes at 10 min post administration

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• patient facing cataract surgery

Exclusion Criteria:

• under 18

• cognitive decline

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The E.Wolfson Medical Center	Holon		Israel	58100

Sponsors and Collaborators

• Wolfson Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Asaf Achiron, Dr.Asaf Achiron, Wolfson Medical Center
• ClinicalTrials.gov Identifier: NCT02506348
• Other Study ID Numbers: 0011-15
• First Posted: Jul 23, 2015
• Last Update Posted: Jul 24, 2015
• Last Verified: Jul 1, 2015

• Additional relevant MeSH terms: Diclofenac; Nepafenac

Study Results

No Results Posted as of Jul 24, 2015