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Cool vs Room-temperature Artificial Tears

Primary Purpose

Diabetic Retinopathy With Macular Edema of Both Eyes (Diagnosis), Central Retinal Vein Occlusion With Macular Edema, Exudative Age-Related Macular Degeneration, Unspecified Eye

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Refresh Plus Preservative-free Lubricant Eye Drops
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Retinopathy With Macular Edema of Both Eyes (Diagnosis)

Eligibility Criteria

18 Years - 105 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients were eligible if they were receiving standard intravitreal injections for their exudative age-related macular degeneration, cystoid macular edema, diabetic macular edema, proliferative diabetic retinopathy, retinal vein occlusion with macular edema, or retinal neovascularization. Exclusion Criteria: Inability or lack of willingness to participate in the study Active ocular infection including infectious uveitis First time receiving intravitreal injection Those who reported never having ocular discomfort following intravitreal injections on the pre-injection questionnaire Less than 18 years of age

Sites / Locations

  • University of Iowa Hospitals & Clinics - Department of Ophthalmology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cooled artificial tear group

Room temperature artificial tear group

Arm Description

Stored at 4 degree Celsius

Stored at 25 degree Celsius

Outcomes

Primary Outcome Measures

The efficacy of cooled versus room temperature artificial tears in reducing post intravitreal injection ocular discomfort as measured by pain scale survey.
The level of subjectively reported pain scale from 1 to 10, where 1 is minimal pain and 10 is extreme pain

Secondary Outcome Measures

Full Information

First Posted
March 14, 2023
Last Updated
April 16, 2023
Sponsor
University of Iowa
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1. Study Identification

Unique Protocol Identification Number
NCT05832996
Brief Title
Cool vs Room-temperature Artificial Tears
Official Title
Randomized Controlled Study of Cooled Versus Room-Temperature Artificial Tears for Reducing Surface Irritation Following Intravitreal Injection
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Background and Objective: To evaluate the efficacy of cooled versus room temperature artificial tears in reducing post intravitreal injection (IVI) ocular discomfort. Patients and Methods: Patients receiving IVI were randomized to either cooled or room temperature tears intervention groups. Both groups rated their ocular discomfort following IVI before intervention and again after administration of cooled or room temperature tears.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy With Macular Edema of Both Eyes (Diagnosis), Central Retinal Vein Occlusion With Macular Edema, Exudative Age-Related Macular Degeneration, Unspecified Eye, Cystoid Macular Edema, Ocular Surface Disease, Dry Eye Sensation, Eye Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cooled artificial tear group
Arm Type
Experimental
Arm Description
Stored at 4 degree Celsius
Arm Title
Room temperature artificial tear group
Arm Type
Active Comparator
Arm Description
Stored at 25 degree Celsius
Intervention Type
Drug
Intervention Name(s)
Refresh Plus Preservative-free Lubricant Eye Drops
Intervention Description
Refresh Plus Preservative-free Lubricant Eye Drops at 4 degree Celsius
Primary Outcome Measure Information:
Title
The efficacy of cooled versus room temperature artificial tears in reducing post intravitreal injection ocular discomfort as measured by pain scale survey.
Description
The level of subjectively reported pain scale from 1 to 10, where 1 is minimal pain and 10 is extreme pain
Time Frame
with 72 hours of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients were eligible if they were receiving standard intravitreal injections for their exudative age-related macular degeneration, cystoid macular edema, diabetic macular edema, proliferative diabetic retinopathy, retinal vein occlusion with macular edema, or retinal neovascularization. Exclusion Criteria: Inability or lack of willingness to participate in the study Active ocular infection including infectious uveitis First time receiving intravitreal injection Those who reported never having ocular discomfort following intravitreal injections on the pre-injection questionnaire Less than 18 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Jin, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa Hospitals & Clinics - Department of Ophthalmology
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

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Cool vs Room-temperature Artificial Tears

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