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Completed

NCT Number: NCT07168265

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

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.

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Key information

Conditions

Androgen Deficiency Ocular Surface Disease Tear Osmolarity

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayıs University

Samsun, Atakum, 55139, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Androgen deficiency

Exclusion criteria

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

Treatment and study plan

androgen replacement therapy

Drug

intramuscular testosterone

Primary outcomes

  1. Tear Osmolarity in mOsm/L

    Time frame: 5 months

    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.

  2. Schirmer Test in mm

    Time frame: 5 months

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

  3. Tear break-up time (TBUT) in sec

    Time frame: 5 months

    TBUT is measured by ophthalmologist after application of fluorecein dye.

  4. MGD-GS score in number

    Time frame: 5 months

    MGD-GS score was performed by ophthalmolgist using biomicroscopy

  5. Questionary Scoring in number

    Time frame: 5 months

    AMS and OSDI scoring charts were completed by the participants.

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

    Time frame: 5 months

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

Sponsors and collaborators

Lead sponsor

Neon Hospital

Other

Registry information

Acronym: EffAndonOS

Important dates

Study start
2020
Primary completion
2020
Study completion
2025
First posted
Sep 11, 2025
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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