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Cool vs Room-temperature Artificial Tears

NCT05832996 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2025-03-04

Study results available
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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.

Conditions

  • 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

Interventions

DRUG

Refresh Plus Preservative-free Lubricant Eye Drops

Refresh Plus Preservative-free Lubricant Eye Drops at either 4 or 25 degree Celsius

Sponsors & Collaborators

  • University of Iowa

    lead OTHER

Principal Investigators

  • Douglas Jin, MD · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
105 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2022-07-01
Completion
2022-07-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05832996 on ClinicalTrials.gov