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

Not Applicable

Completed

• Conditions: Dry Eye

• Registration Number: NCT06875687
• Lead Sponsor: University of Seville

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-15
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28
• Status Verified: 2025-03
• Study First Submitted: 2025-03-07
• Study First Submitted QC: 2025-03-07
• Last Update Submitted: 2025-03-24
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Tear Film Stability (A-NIBUT) After Six Weeks of Eyelash Serum Application	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 Outcome Measures

Name	Time	Method
Change in Eyelash Length and Thickness After Six Weeks	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.
Change in Tear Volume (Tear Meniscus Height - TMH) After Six Weeks	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.
Change in Ocular Hyperemia (Conjunctival and Ciliary Hyperemia) After Six Weeks	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.

Trial Locations

Locations (1)

University of Seville; 🇪🇸 Seville, Spain