Trial Outcomes & Findings for Effect of Artificial Tears on Radioiodine Levels in the Nasolacrimal Duct System (NCT NCT04327999)

Last Updated: 2024-01-18

Results Overview

The radioactive iodine activity level in the tears will be measured, as collected via contact lenses. Each patient will have a control eye and an experimental eye that received artificial tears. The control eye has no intervention. The radioactive iodine activity level will be measured over four days, with Day 1 occurring on the Day of systemic radioactive iodine therapy. On each of the four days, the level of radioactive iodine will be compared between the control and experimental eyes to see if there is a statistical difference between the control and experimental eyes.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

Over a 4 day period

Results posted on

2024-01-18

Participant Flow

Participant milestones

Participant milestones
Measure	Preservative Free Artificial Tears Day 1, patients will self-administer artificial tears every 15 minutes for 2 hours followed by every 30 minutes for at least 4 hours or until bedtime at night. On Day 2, patients will self-administer artificial tears every 1 hour for 12 hours. On Day 3, patients will self-administer artificial tears four times that day. On Day 4, patients will self-administer tears twice that day. Patients will be instructed to wear their contact lenses throughout their waking hours. Artificial Tears: Self-Administered - utilizing eye drop preservative free vials
Overall Study STARTED	9
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Preservative Free Artificial Tears Day 1, patients will self-administer artificial tears every 15 minutes for 2 hours followed by every 30 minutes for at least 4 hours or until bedtime at night. On Day 2, patients will self-administer artificial tears every 1 hour for 12 hours. On Day 3, patients will self-administer artificial tears four times that day. On Day 4, patients will self-administer tears twice that day. Patients will be instructed to wear their contact lenses throughout their waking hours. Artificial Tears: Self-Administered - utilizing eye drop preservative free vials
Overall Study Protocol Violation	1

Baseline Characteristics

Effect of Artificial Tears on Radioiodine Levels in the Nasolacrimal Duct System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Preservative Free Artificial Tears n=9 Participants Day 1, patients will self-administer artificial tears every 15 minutes for 2 hours followed by every 30 minutes for at least 4 hours or until bedtime at night. On Day 2, patients will self-administer artificial tears every 1 hour for 12 hours. On Day 3, patients will self-administer artificial tears four times that day. On Day 4, patients will self-administer tears twice that day. Patients will be instructed to wear their contact lenses throughout their waking hours. Artificial Tears: Self-Administered - utilizing eye drop preservative free vials
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: Over a 4 day period

Outcome measures

Outcome measures
Measure	Preservative Free Artificial Tears n=8 Participants Day 1, patients will self-administer artificial tears every 15 minutes for 2 hours followed by every 30 minutes for at least 4 hours or until bedtime at night. On Day 2, patients will self-administer artificial tears every 1 hour for 12 hours. On Day 3, patients will self-administer artificial tears four times that day. On Day 4, patients will self-administer tears twice that day. Patients will be instructed to wear their contact lenses throughout their waking hours. Artificial Tears: Self-Administered - utilizing eye drop preservative free vials
Change in Level of Radioactive Iodine in Tears	2975.7 Becquerel Interval 1579.0 to 5609.0

Adverse Events

Preservative Free Artificial Tears

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Preservative Free Artificial Tears n=9 participants at risk Day 1, patients will self-administer artificial tears every 15 minutes for 2 hours followed by every 30 minutes for at least 4 hours or until bedtime at night. On Day 2, patients will self-administer artificial tears every 1 hour for 12 hours. On Day 3, patients will self-administer artificial tears four times that day. On Day 4, patients will self-administer tears twice that day. Patients will be instructed to wear their contact lenses throughout their waking hours. Artificial Tears: Self-Administered - utilizing eye drop preservative free vials
Nervous system disorders Early vasovagal response	11.1% 1/9 • Number of events 1 • Approximately 32 months and 15 days.

Additional Information

Teresa Melton

Vanderbilt-Ingram Cancer Center

Phone: 615-936-7423

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place