Clinical trial NCT06875687: Prostaglandin Analog Eyelash Serum and Ocular Surface Health: A Prospective Study
Official title: Effects of a Prostaglandin Analog-Based Eyelash Serum on Ocular Surface Integrity and Tear Film Stability: A Prospective Interventional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: Prostaglandin analog
Eyelash growth
Ocular surface
Tear film stability
Ophthalmic safety
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, interventional study evaluating the effects of a prostaglandin analog-based eyelash serum on ocular surface integrity, tear film stability, and eyelash growth over six weeks. All participants applied the serum daily, and clinical assessments were performed at baseline and post-treatment.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Tear Film Stability (A-NIBUT) After Six Weeks of Eyelash Serum Application
timeFrame: Baseline and after six weeks of serum application
Secondary outcomes:
measure: Change in Tear Volume (Tear Meniscus Height - TMH) After Six Weeks
timeFrame: Baseline and after six weeks
measure: Change in Ocular Hyperemia (Conjunctival and Ciliary Hyperemia) After Six Weeks
timeFrame: Baseline and after six weeks
measure: Change in Eyelash Length and Thickness After Six Weeks
timeFrame: Baseline and after six weeks
Other outcomes:
Locations:
city: Seville
country: Spain
facility: University of Seville
Study officials:
References:
citation: Alonso MR, Damonte SP, Anesini C. Jarilla-Coffea extract: a natural cosmetic product that improves eyelash and eyebrow growth in women. Clin Cosmet Investig Dermatol. 2019 Jan 9;12:47-55. doi: 10.2147/CCID.S182497. eCollection 2019.
citation: Fernandez-Gonzalez P, Truchuelo-Diez MT, Gomez-Sanchez MJ. Open clinical trial evaluating the efficacy of a novel eyelash growth enhancer with peptides and glycosaminoglycans. J Cosmet Dermatol. 2024 Jun;23(6):2170-2180. doi: 10.1111/jocd.16265. Epub 2024 Apr 4.
citation: Sachdev M, Velugotla K, Revanker S, Somasekhar G. An Open-label, Single-center, Safety and Efficacy Study of Eyelash Polygrowth Factor Serum. J Clin Aesthet Dermatol. 2020 Feb;13(2):61-66. Epub 2020 Feb 1.
citation: Kim YK, Woo IS, Park CG, Kim A, Choi JD, Son KH, Han KM. Green extraction of prostaglandin analogs in cosmetics using deep eutectic solvents and detection via LC-MS/MS. J Chromatogr A. 2025 Jan 4;1739:465516. doi: 10.1016/j.chroma.2024.465516. Epub 2024 Nov 13.
citation: Baiyasi M, St Claire K, Hengy M, Tur K, Fahs F, Potts G. Eyelash serums: A comprehensive review. J Cosmet Dermatol. 2024 Jul;23(7):2328-2344. doi: 10.1111/jocd.16278. Epub 2024 Mar 12.