Trial Outcomes & Findings for Effect of Topical Botulinum Toxin Eyedrop on Palpebral Fissure (NCT NCT06080438)

Last Updated: 2024-12-05

Results Overview

Palpebral fissure on Day 3 minus palpebral fissure at baseline. Palpebral fissure is the area between the upper and lower eyelid margins. Palpebral fissure height on eyes is measured in primary gaze position with a clear ruler held in a central vertical position between the upper and lower eyelid margin.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

2 participants

Primary outcome timeframe

baseline and Day 3

Results posted on

2024-12-05

Participant Flow

For interim analysis of futility, the investigators conducted the study with BT eye drops on first 10 patients and then evaluate the results to see if there are any significant effects. If clinically significant effects are seen, then 34 patients totally (17 in BT vs 17 in saline) are included. The study was terminated and did not continue; therefore, only the first phase of the study was conducted with only one arm (BT eye drops) with results reported for the first phase only.

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	Botulinum Toxin Group The left eye of each participant will receive botulinum toxin eye drops and will remain in this group for up to 40 minutes. Botulinum toxin: 15 units of botulinum toxin administered one time to the eye via eye drops
Overall Study STARTED	2 2
Overall Study COMPLETED	0 0
Overall Study NOT COMPLETED	2 2

Reasons for withdrawal

Reasons for withdrawal
Measure	Botulinum Toxin Group The left eye of each participant will receive botulinum toxin eye drops and will remain in this group for up to 40 minutes. Botulinum toxin: 15 units of botulinum toxin administered one time to the eye via eye drops
Overall Study Lost to Follow-up	2

Baseline Characteristics

Effect of Topical Botulinum Toxin Eyedrop on Palpebral Fissure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Botulinum Toxin Group n=2 eyes The left eye of each participant will receive botulinum toxin eye drops and will remain in this group for up to 40 minutes. Botulinum toxin: 15 units of botulinum toxin administered one time to the eye via eye drops
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	57 years STANDARD_DEVIATION 4.2 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 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	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Palpebral fissure	11.75 mm STANDARD_DEVIATION 0.42 • n=32 eyes

PRIMARY outcome

Timeframe: baseline and Day 3

Outcome measures

Outcome measures
Measure	Botulinum Toxin Group n=2 eyes The left eye of each participant will receive botulinum toxin eye drops and will remain in this group for up to 40 minutes. Botulinum toxin: 15 units of botulinum toxin administered one time to the eye via eye drops
Change in Palpebral Fissure Height	-0.5 mm Standard Deviation 0.69

SECONDARY outcome

Timeframe: Baseline

Scoring of the ocular surface will be done by fluorescein staining and evaluating with a slit lamp and grading scale: 0-3 0 (no punctate staining) 1. (sparse density) 2. (moderate density) 3. (high density and overlapping lesions).

Outcome measures

Outcome measures
Measure	Botulinum Toxin Group n=2 eyes The left eye of each participant will receive botulinum toxin eye drops and will remain in this group for up to 40 minutes. Botulinum toxin: 15 units of botulinum toxin administered one time to the eye via eye drops
Corneal Staining Density	2 score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Day 3

Outcome measures

Outcome measures
Measure	Botulinum Toxin Group n=2 eyes The left eye of each participant will receive botulinum toxin eye drops and will remain in this group for up to 40 minutes. Botulinum toxin: 15 units of botulinum toxin administered one time to the eye via eye drops
Corneal Staining Density	2 score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: baseline and Day 3

Change in tearing will be calculated as tearing on Day 3 minus tearing at baseline. Tearing will be assessed using the Schirmer test with anesthesia. Schirmer strip is inserted into the lower conjunctival sac at the junction of the lateral and middle thirds, avoiding touching the cornea, and the length of wetting strips in millimeters is recorded after 5 minutes. The result can range from a minimum of 0 mm (no tearing) to a maximum of 35 mm (maximum tearing).

Outcome measures

Outcome measures
Measure	Botulinum Toxin Group n=2 eyes The left eye of each participant will receive botulinum toxin eye drops and will remain in this group for up to 40 minutes. Botulinum toxin: 15 units of botulinum toxin administered one time to the eye via eye drops
Change in Tearing	3 mm Standard Deviation 5.54

Adverse Events

Botulinum Toxin 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

Principal investigator

University of Miami

Phone: 305-326-6434

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place