Trial Outcomes & Findings for Pupil Dilation for Treatment of IFIS (NCT NCT03760185)

Results Overview

The primary outcome measure is pupil diameter size post dilation (using standard dilating medications of phenylephrine 10%, tropicamide 1%, and cyclopentolate 1%) of the brimonidine tartrate pre-treated eye compared to the non-treated eye

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

45 minutes post dilation after 7 days of treatment

Results posted on

2022-04-20

Participant Flow

Patients will be screened at their annual eye examination at the hospital eye clinic.

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	Brimonidine Tartrate 0.2% All enrolled subjects will receive the interventional drug, Brimonidine tartrate 0.2%, to be applied to ONE eye only.	Control- Untreated All subjects enrolled will have one eye serve as a control and will not receive the Brimonidine Tartrate 0.2% treatment
Overall Study STARTED	13 13	13 13
Overall Study COMPLETED	12 12	12 12
Overall Study NOT COMPLETED	1 1	1 1

Reasons for withdrawal

Reasons for withdrawal
Measure	Brimonidine Tartrate 0.2% All enrolled subjects will receive the interventional drug, Brimonidine tartrate 0.2%, to be applied to ONE eye only.	Control- Untreated All subjects enrolled will have one eye serve as a control and will not receive the Brimonidine Tartrate 0.2% treatment
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Patients n=13 Participants All patients in this arm will receive eye drops to be applied to one eye only. The alternative eye will not receive any eye drops and as such will serve as the control. Brimonidine Tartrate: All subjects will apply brimonidine tartrate to one eye only for the duration of study participation.
Age, Continuous	61.9 years STANDARD_DEVIATION 10.1 • n=13 Participants
Sex: Female, Male Female	0 Participants n=13 Participants
Sex: Female, Male Male	13 Participants n=13 Participants
Pre-Study Treatment Pupil Diameter Dilated	6.50 milimeters STANDARD_DEVIATION 1.28 • n=13 Participants

PRIMARY outcome

Timeframe: 45 minutes post dilation after 7 days of treatment

Population: One participant did not show for their follow-up visit after treatment.

The primary outcome measure is pupil diameter size post dilation (using standard dilating medications of phenylephrine 10%, tropicamide 1%, and cyclopentolate 1%) of the brimonidine tartrate pre-treated eye compared to the non-treated eye

Outcome measures

Outcome measures
Measure	Brimonidine Tartrate 0.2% n=12 eyes The eye that was treated with Brimonidine Tartrate 0.2%.	Control - Untreated n=12 eyes Eye of participant that was not treated with Brimonidine Tartrate 0.2%
Pupil Dilation Sized of the Treated Eye Compared to the Non-treated Eye	6.76 millimeters Standard Deviation 2.57	7.17 millimeters Standard Deviation 1.20

SECONDARY outcome

Timeframe: 45 minutes post dilation after 7 days of treatment

Population: 1 patient did not return for their post-treatment follow-up visit

Change in pupil diameter of each eye after dilation at the start of the study compared to pupil post dilating drops at the end of the study

Outcome measures

Outcome measures
Measure	Brimonidine Tartrate 0.2% n=12 eyes The eye that was treated with Brimonidine Tartrate 0.2%.	Control - Untreated n=12 eyes Eye of participant that was not treated with Brimonidine Tartrate 0.2%
Change in Pupil Diameter of Each Eye After Dilation at the Start of the Study Compared to Pupil Post Dilating Drops at the End of the Study	0.39 millimeters Standard Deviation 2.20	0.91 millimeters Standard Deviation 1.53

Adverse Events

Brimonidine Tartrate 0.2%

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Control- Untreated

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Brimonidine Tartrate 0.2% n=13 participants at risk The eye that was treated with Brimonidine Tartrate 0.2%.	Control- Untreated n=13 participants at risk The eye that was not treated with Brimonidine Tartrate 0.2%.
Reproductive system and breast disorders Surgery- Cryoablation of prostate	7.7% 1/13 • Number of events 1 • up to 30 days from enrollment.	7.7% 1/13 • Number of events 1 • up to 30 days from enrollment.

Other adverse events

Other adverse events
Measure	Brimonidine Tartrate 0.2% n=13 participants at risk The eye that was treated with Brimonidine Tartrate 0.2%.	Control- Untreated n=13 participants at risk The eye that was not treated with Brimonidine Tartrate 0.2%.
Renal and urinary disorders Kidney & Urinary tract	7.7% 1/13 • Number of events 2 • up to 30 days from enrollment.	7.7% 1/13 • Number of events 2 • up to 30 days from enrollment.
Eye disorders Ophthalmology - Cataracts	7.7% 1/13 • Number of events 1 • up to 30 days from enrollment.	7.7% 1/13 • Number of events 1 • up to 30 days from enrollment.
Cardiac disorders Cardio - MI	7.7% 1/13 • Number of events 1 • up to 30 days from enrollment.	7.7% 1/13 • Number of events 1 • up to 30 days from enrollment.

Additional Information

Dr Cristos Ifantides

Denver Health and Hospital Authority

Phone: 303-436-4949

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place