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

March 24, 2025 updated by: José-María Sánchez-González, University of Seville

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Seville, Spain, 41012
        • University of Seville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prostaglandin Analog-Based Eyelash Serum Group
This study arm consists of healthy female participants who applied a prostaglandin analog-based eyelash serum once daily to the upper eyelid margin for six weeks. The study evaluated changes in ocular surface integrity, tear film stability, and eyelash growth. Clinical assessments were performed at baseline and post-treatment, including measurements of tear film parameters, ocular hyperemia, and intraocular pressure.
Other: Prostaglandin Analog-Based Eyelash Serum
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and after six weeks of serum application

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and after six weeks
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.
Baseline and after six weeks
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.
Baseline and after six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Seville

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2025

Primary Completion (Actual)

February 28, 2025

Study Completion (Actual)

February 28, 2025

Study Registration Dates

First Submitted

March 7, 2025

First Submitted That Met QC Criteria

March 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USeville_2025_02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to privacy concerns and ethical considerations. The collected data include sensitive ocular health parameters, and sharing such data could compromise participant confidentiality. However, aggregated data and study results will be available upon reasonable request for academic and research purposes.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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