Trial Outcomes & Findings for Cool vs Room-temperature Artificial Tears (NCT NCT05832996)

NCT ID: NCT05832996

Last Updated: 2025-03-04

Results Overview

The level of subjectively reported pain scale from 1 to 10, where 1 is minimal pain and 10 is extreme pain

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 124 participants
• Primary outcome timeframe: with 72 hours of the intervention
• Results posted on: 2025-03-04

Participant Flow

Participant milestones

Measure	Cooled Artificial Tear Group Stored at 4 degree Celsius Refresh Plus Preservative-free Lubricant Eye Drops: Refresh Plus Preservative-free Lubricant Eye Drops at 4 degree Celsius	Room Temperature Artificial Tear Group Stored at 25 degree Celsius Refresh Plus Preservative-free Lubricant Eye Drops: Refresh Plus Preservative-free Lubricant Eye Drops at 4 degree Celsius
Overall Study STARTED	56	68
Overall Study COMPLETED	48	61
Overall Study NOT COMPLETED	8	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cool vs Room-temperature Artificial Tears

Baseline characteristics by cohort

Measure	Cooled Artificial Tear Group n=48 Participants Stored at 4 degree Celsius Refresh Plus Preservative-free Lubricant Eye Drops: Refresh Plus Preservative-free Lubricant Eye Drops at 4 degree Celsius	Room Temperature Artificial Tear Group n=61 Participants Stored at 25 degree Celsius Refresh Plus Preservative-free Lubricant Eye Drops: Refresh Plus Preservative-free Lubricant Eye Drops at 4 degree Celsius	Total n=109 Participants Total of all reporting groups
Age, Continuous	69.1 years STANDARD_DEVIATION 15.9 • n=5 Participants	68.3 years STANDARD_DEVIATION 15.4 • n=7 Participants	68.7 years STANDARD_DEVIATION 15.7 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	45 Participants n=7 Participants	77 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	47 Participants n=5 Participants	59 Participants n=7 Participants	106 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: with 72 hours of the intervention

The level of subjectively reported pain scale from 1 to 10, where 1 is minimal pain and 10 is extreme pain

Outcome measures

Measure	Cooled Artificial Tear Group n=48 Participants Stored at 4 degree Celsius Refresh Plus Preservative-free Lubricant Eye Drops: Refresh Plus Preservative-free Lubricant Eye Drops at 4 degree Celsius	Room Temperature Artificial Tear Group n=61 Participants Stored at 25 degree Celsius Refresh Plus Preservative-free Lubricant Eye Drops: Refresh Plus Preservative-free Lubricant Eye Drops at 4 degree Celsius
The Efficacy of Cooled Versus Room Temperature Artificial Tears in Reducing Post Intravitreal Injection Ocular Discomfort as Measured by Pain Scale Survey.	2.21 score on a scale Standard Deviation 0.2	1.95 score on a scale Standard Deviation 0.2

Adverse Events

Cooled Artificial Tear Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Room Temperature Artificial Tear Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Douglas Jin, MD

University of Iowa

Phone: 319-356-3185

Email: Douglas-Jin@uiowa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place