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Completed

NCT Number: NCT06875687

Prostaglandin Analog Eyelash Serum and Ocular Surface Health: A Prospective Study

This prospective interventional study investigates the effects of a prostaglandin analog-based eyelash serum on ocular surface integrity, tear film stability, and eyelash growth over six weeks. Nineteen healthy female participants applied the serum daily, with clinical assessments performed at baseline and post-treatment. The study adhered to ethical guidelines, and parameters such as tear film stability, tear volume, ocular hyperemia, and eyelash characteristics were evaluated.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Seville

Seville, 41012, Spain

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Female individuals aged 18 to 30 years.
  • Corrected distance visual acuity (CDVA) of 0.10 LogMAR or better in both eyes.
  • Fitzpatrick skin type III or lower.
  • No active dermatological conditions affecting the periocular area.
  • Regular use of cosmetic products (e.g., mascara, eyeliner, or eyeshadow) with no history of intolerance.
  • Willingness and ability to follow the serum application protocol for six weeks.

Exclusion criteria

  • History or diagnosis of dry eye disease or other ocular surface disorders.
  • Previous ocular surgery, trauma, or systemic conditions affecting ocular surface function.
  • Use of topical or systemic medications that could impact tear film stability.
  • Documented hypersensitivity or allergic reactions to cosmetic or ophthalmic products.
  • Presence of eyelid disorders that could interfere with eyelash growth (e.g., blepharitis, trichiasis).
  • Use of growth-enhancing serums within the past three months.
  • Pregnancy or breastfeeding at the time of enrollment.

Treatment and study plan

Prostaglandin Analog-Based Eyelash Serum

Other

This intervention consists of a prostaglandin analog-based eyelash serum applied once daily to the upper eyelid margin for six weeks. The serum contains dechloro dihydroxy difluoro ethylcloprostenolamide (DDDE), a prostaglandin analog known to promote eyelash growth. The formulation also includes panax ginseng root extract, urtica dioica extract, panthenol, niacinamide, and biotinoyl tripeptide-1, which contribute to hair follicle nourishment. The study evaluates its effects on ocular surface integrity, tear film stability, and eyelash growth.

Other names: Eyelash Growth Serum, Prostaglandin Analog Eyelash Enhancer

Primary outcomes

  1. Change in Tear Film Stability (A-NIBUT) After Six Weeks of Eyelash Serum Application

    Time frame: Baseline and after six weeks of serum application

    Assessment of average non-invasive tear break-up time (A-NIBUT) as an indicator of tear film stability before and after six weeks of daily prostaglandin analog-based eyelash serum application. A-NIBUT is measured using the Firefly S390I slit lamp (MediWorks, Suzhou, China), with lower values indicating increased tear film instability.

Secondary outcomes

  1. Change in Tear Volume (Tear Meniscus Height - TMH) After Six Weeks

    Time frame: Baseline and after six weeks

    Measurement of tear meniscus height (TMH) before and after six weeks of eyelash serum application using the Firefly S390I slit lamp to assess changes in aqueous tear volume. Lower TMH values indicate a reduction in tear production.

  2. Change in Ocular Hyperemia (Conjunctival and Ciliary Hyperemia) After Six Weeks

    Time frame: Baseline and after six weeks

    Evaluation of temporal conjunctival hyperemia (TCOH) and temporal ciliary hyperemia (TCIH) using digital image analysis. An increase in hyperemia suggests a vasodilatory response to the serum.

  3. Change in Eyelash Length and Thickness After Six Weeks

    Time frame: Baseline and after six weeks

    Measurement of eyelash length and thickness before and after six weeks using caliper software on the Firefly S390I slit lamp to determine the efficacy of the serum in promoting eyelash growth.

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Registry information

Official study title

Effects of a Prostaglandin Analog-Based Eyelash Serum on Ocular Surface Integrity and Tear Film Stability: A Prospective Interventional Study

Acronym: EYESERUM

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2025
Registry last updated
Mar 28, 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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