The Effects of Androgen Replacement Therapy on Tear Osmolarity and Ocular Surface Parameters in Androgen Deficiency

NCT07168265 | Completed

• 2 other identifiers: OMU KAEK 2021/557OMU
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To evaluate tear osmolarity and ocular surface findings in men with androgen deficiency (AD) and assess changes after androgen replacement therapy (ART). Design: A prospective interventional study. Participants and Methods Right eyes of 77 male participants were evaluated in this study. Serum total testosterone level were measured, and participants were categorized as AD group (testicular hypofunction, n=37, testosterone level \<231 ng/dL) and control group (healthy controls, n=40, testosterone level \>346 ng/dL). The parameters including Aging Male Symptoms Scale(AMS), OSDI scores, Meibomian Gland Dysfunction- Grading System(MGD-GS) scores, corneal staining, tear break-up time(TBUT), Schirmer I/II tests, tear osmolarity, the depth (TMD), the height (TMH) and the area (TMA) of inferior tear meniscus were investigated. AD group received intramuscular testosterone every two weeks. Main Outcome Measures: The changes in the ocular surface parameters were investigated during the ART while comparing the values of these parameters between the AD and control groups at baseline, 6th and 18th weeks of the treatment.

Conditions

Androgen Deficiency; Ocular Surface Disease; Tear Osmolarity

Keywords

androgen deficiency; ocular surface; tear osmolarity

Outcome Measures

Primary Outcomes (6)

• Tear Osmolarity in mOsm/L

  Tear osmolarity was measured by TearLab device in patients. The changes in the tear osmolarity were investigated during the ART while comparing the values of these parameters between the AD and control groups at baseline, 6th and 18th weeks of the treatment.

  5 months

• Schirmer Test in mm

  Schirmer Test is applied by Schirmer tear paper after anesthesic drop administration into the eye.

  5 months

• Tear break-up time (TBUT) in sec

  TBUT is measured by ophthalmologist after application of fluorecein dye.

  5 months

• MGD-GS score in number

  MGD-GS score was performed by ophthalmolgist using biomicroscopy

  5 months

• Questionary Scoring in number

  AMS and OSDI scoring charts were completed by the participants.

  5 months

• Optical Coherence Tomography findings: TMH, TMA, and TMD in microns

  Tear meniscus height (TMH), area (TMA), and depth (TMD) were measured by Optical coherence tomography in each participants.

  5 months

Study Arms (1)

testosterone

OTHER

Drug: androgen replacement therapy

Interventions

androgen replacement therapy DRUG

intramuscular testosterone

testosterone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Androgen deficiency

You may not qualify if:

• having any ocular disease, history of surgery, drop use

Sponsors & Collaborators

• Neon Hospital: lead

Study Sites (1)

Ondokuz Mayıs University

Samsun, Atakum, 55139, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2025
• First Posted: September 11, 2025
• Study Start: January 1, 2020
• Primary Completion: August 30, 2020
• Study Completion: June 15, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

TU (1)