Trial Outcomes & Findings for Does Topical Ophthalmic Anesthetic Prior to Probing and Irrigation Decrease Pain? (NCT NCT04229771)

Results Overview

Participants completed a survey which asked which procedure was more uncomfortable (left or right). Assignment to receive proparacaine hydrochloride was compared to survey results. When the participant reported less discomfort in the eye that received the proparacaine hydrochloride medication, this is is reported as concordance between reduction of pain/discomfort and anesthetic use.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

2 participants

Primary outcome timeframe

1 minute

Results posted on

2023-01-19

Participant Flow

Participant milestones

Participant milestones
Measure	Participants Who Received Proparacaine Hydrochloride Solution in Left Eye and Placebo in Right Eye Participants will have received a drop of Proparacaine Hydrocholoride 0.5% ophthalmic solution in left eye and a drop of basic salt solution (BSS, placebo) in the right eye prior to probing and irrigation. Proparacaine Hydrochloride ophthalmic solution, United States Pharmacopeia (USP) 0.5%: One drop instilled in left eye, as topical anesthetic Balanced salt solution: One drop instilled in right eye, as control placebo	Participants Who Received Proparacaine Hydrochloride Solution in Right Eye and Placebo in Left Eye Participants will have received a drop of Proparacaine Hydrocholoride 0.5% ophthalmic solution in right eye and a drop of basic salt solution (BSS, placebo) in the left prior to probing and irrigation. Proparacaine Hydrochloride ophthalmic solution, United States Pharmacopeia (USP) 0.5%: One drop instilled in right eye, as topical anesthetic Balanced salt solution: One drop instilled in left eye, as control placebo
Overall Study STARTED	2	0
Overall Study COMPLETED	2	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants Who Received Proparacaine Hydrochloride Solution in Left Eye and Placebo in Right Eye n=4 eyes Participants will have received a drop of Proparacaine Hydrocholoride 0.5% ophthalmic solution in left eye and a drop of balanced salt solution (BSS, placebo) in the right eye prior to probing and irrigation. Proparacaine Hydrochloride ophthalmic solution, USP 0.5%: One drop instilled in left eye, as topical anesthetic Balanced salt solution: One drop instilled in right eye, as control placebo	Participants Who Received Proparacaine Hydrochloride Solution in Right Eye and Placebo in Left Eye Participants will have received a drop of Proparacaine Hydrocholoride 0.5% ophthalmic solution in right eye and a drop of balanced salt solution (BSS, placebo) in the left prior to probing and irrigation. Proparacaine Hydrochloride ophthalmic solution, USP 0.5%: One drop instilled in right eye, as topical anesthetic Balanced salt solution: One drop instilled in left eye as control placebo	Total n=4 eyes Total of all reporting groups
Age, Continuous	69.5 years STANDARD_DEVIATION 7.7 • n=2 Participants	—	69.5 years STANDARD_DEVIATION 7.7 • n=2 Participants
Sex: Female, Male Female	1 Participants n=2 Participants	—	1 Participants n=2 Participants
Sex: Female, Male Male	1 Participants n=2 Participants	—	1 Participants n=2 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	2 participants n=2 Participants	—	2 participants n=2 Participants

PRIMARY outcome

Timeframe: 1 minute

Population: No participants were randomized to arm "Participants who received proparacaine hydrochloride in right eye and placebo in left eye."

Participants completed a survey which asked which procedure was more uncomfortable (left or right). Assignment to receive proparacaine hydrochloride was compared to survey results. When the participant reported less discomfort in the eye that received the proparacaine hydrochloride medication, this is is reported as concordance between reduction of pain/discomfort and anesthetic use.

Outcome measures

Outcome measures
Measure	Participants Who Received Proparacaine Hydrochloride Solution in Left Eye and Placebo in Right Eye n=2 Participants Participants will have received a drop of Proparacaine Hydrocholoride 0.5% ophthalmic solution in left eye and a drop of balanced salt solution (BSS, placebo) in the right eye prior to probing and irrigation. Proparacaine Hydrochloride ophthalmic solution, USP 0.5%: One drop instilled in left eye, as topical anesthetic Balanced salt solution: One drop instilled in right eye as control placebo	Participants Who Received Proparacaine Hydrochloride Solution in Right Eye and Placebo in Left Eye Participants will have received a drop of Proparacaine Hydrocholoride 0.5% ophthalmic solution in right eye and a drop of basic salt solution (BSS, placebo) in the left prior to probing and irrigation. Proparacaine Hydrochloride ophthalmic solution, USP 0.5%: One drop instilled in right eye, as topical anesthetic Balanced salt solution: One drop instilled in one eye, randomly chosen, as control placebo
Count of Participants Who Report of Less Discomfort in the Eye That Received the Proparacaine Hydrochloride Anesthetic During Probing	1 Participants	0 Participants

Adverse Events

Participants Who Received Proparacaine Hydrochloride Solution in Left Eye and Placebo in Left Eye

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Participants Who Received Proparacaine Hydrochloride Solution in Right Eye and Placebo in Left Eye

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

Dr. Dianne Schlachter, Staff Physician

William Beaumont Hospital

Phone: 248-551-2020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place