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Natesto in Moderate to Severe Dry Eye
NCT06154200Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2023
- Primary completion
- Apr 2024
- Countries
- 1
- Sponsor
- Marshall B. Ketchum University
- Modality
- Small Molecules
- Drugs
- natesto
- Conditions
- dry eye syndrome (DED)
01
Overview
Phase 2, randomised, double-blind trial of natesto in dry eye syndrome (DED) (2 arms), sponsored by Marshall B. Ketchum University. Primary endpoint: Tear Break up Time at 4 weeks. Started Apr 2023; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Testosterone gel 4.5%
Natesto gel applied to eyelids twice per day.
Vehicle Gel
Placebo vehicle gel applied to eyelids twice per day.
03
Who it enrols
Adults with moderate to severe dry eye (TBUT < 6s, staining > 1.5, or Schirmer < 5mm) excluding those with high PSA, BPH, recent cardiovascular/liver events, or diabetes.
04
Endpoints
Primary
Tear Break up Time
Secondary
Lower Meibomian Gland Secretion Score
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