Transdermal androgen in patients with aqueous deficient dry eye

Not Applicable

Completed

• Conditions: Dry eye; transdermal androgen, androgen, androgel, aqueous deficient dry eye

• Registration Number: TCTR20160324001
• Lead Sponsor: Faculty of medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-24
• Study Completion: 2016-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

-The menopause women or women who underwent bilateral salpingo-oophorectomy
-The men who have the low level of serum testosterone (normal level 1.93-7.40 ng/mL)
-The volunteers who have the sign and symptom of dry eye disease such as Ocular surface disease index score (OSDI) more than 12, fluorescein tear break up time (TBUT) less than 10 sec., Schirmer test I less than 10 mm. or positive corneal fluorescein staining
- No previous androgen replacement therapy within 3months

Exclusion Criteria

-History of androgen hypersensitivity or ethanol hypersensitivity
- History of breast cancer
- History of prostate cancer
- History of skin disease or skin inflammation at apply area
-Can not follow up 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ocular surface and dry eye at week4 Ocular surface disease index score, VA, corneal fluorescein staining, TBUT, Schirmer test I

Secondary Outcome Measures

Name	Time	Method
Serum testosterone level and and sex-hormone binding globulin (SHBG) level at week4 Serum testosterone and and sex-hormone binding globulin (SHBG)