Trial Outcomes & Findings for Eyelid Androgen Treatment in Dry Eye (NCT NCT06154200)

NCT ID: NCT06154200

Last Updated: 2025-05-25

Results Overview

Time to first dark spot appearance in the tear film

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 24 participants
• Primary outcome timeframe: From baseline to 4 weeks treatment
• Results posted on: 2025-05-25

Participant Flow

Participant milestones

Measure	Vehicle Gel Vehicle gel applied to eyelids twice per day Vehicle gel: Vehicle gel applied to eyelids twice per day	Testosterone Gel 4.5% Testosterone gel 4.5% applied to eyelids twice per day Testosterone gel 4.5%: Testosterone gel applied to eyelids twice per day
Overall Study STARTED	12	12
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Eyelid Androgen Treatment in Dry Eye

Baseline characteristics by cohort

Measure	Vehicle Gel n=12 Participants Vehicle gel applied to eyelids twice per day Vehicle gel: Vehicle gel applied to eyelids twice per day	Testosterone Gel 4.5% n=12 Participants Testosterone gel 4.5% applied to eyelids twice per day Testosterone gel 4.5%: Testosterone gel applied to eyelids twice per day	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	51.0 years STANDARD_DEVIATION 14.6 • n=5 Participants	52.9 years STANDARD_DEVIATION 11.3 • n=7 Participants	52.0 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 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	6 Participants n=5 Participants	3 Participants n=7 Participants	9 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	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	9 Participants n=7 Participants	15 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants
Fluorescein tear breakup time	3.3 seconds STANDARD_DEVIATION 0.9 • n=5 Participants	3.6 seconds STANDARD_DEVIATION 1.2 • n=7 Participants	3.5 seconds STANDARD_DEVIATION 1.1 • n=5 Participants

PRIMARY outcome

Timeframe: From baseline to 4 weeks treatment

Time to first dark spot appearance in the tear film

Outcome measures

Measure	Vehicle Gel n=12 eyes Vehicle gel applied to eyelids twice per day Vehicle gel: Vehicle gel applied to eyelids twice per day	Testosterone Gel 4.5% n=12 eyes Testosterone gel 4.5% applied to eyelids twice per day Testosterone gel 4.5%: Testosterone gel applied to eyelids twice per day
Tear Break up Time	0.0 seconds Standard Deviation 1.2	2.9 seconds Standard Deviation 1.3

SECONDARY outcome

Timeframe: From baseline to 4 weeks treatment

8 central lower meibomian glands are evaluated using gentle (vs forceful) expression. Each secretion is given a score of 0 (clear normal meibum), 1 (cloudy low viscosity) 2 (thick, opaque, 3 inspissated or 4 (no secretion visible). One-half scale increments are used.

Outcome measures

Measure	Vehicle Gel n=12 eyes Vehicle gel applied to eyelids twice per day Vehicle gel: Vehicle gel applied to eyelids twice per day	Testosterone Gel 4.5% n=12 eyes Testosterone gel 4.5% applied to eyelids twice per day Testosterone gel 4.5%: Testosterone gel applied to eyelids twice per day
Lower Meibomian Gland Secretion Score (0 - 32 Scale)	0.7 units on a scale Standard Deviation 0.3	5.5 units on a scale Standard Deviation 2.1

Adverse Events

Vehicle Gel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Testosterone Gel 4.5%

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. Jerry Paugh, Professor Emeritus

SCCO at MBKU

Phone: 7144497487

Email: jpaugh@ketchum.edu

Results disclosure agreements

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