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Dry EyeEYESERUMNCT06875687

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

A study testing Prostaglandin Analog-Based Eyelash Serum in people with Dry Eye, run by University of Seville at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 30 years, women onlyHealthy volunteers can take part
Conditions the study is for
Dry Eye
What is being tested?
Prostaglandin Analog-Based Eyelash Serum
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteSpain
Study dates
15 Jan 2025to 28 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • University of Seville

    Seville, 41012

Other trials in Spain

About this study

Official title: 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.

Conditions
Dry Eye
Being tested
Prostaglandin Analog-Based Eyelash Serum
Keywords
Prostaglandin analog, Eyelash growth, Ocular surface, Tear film stability, Ophthalmic safety
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prostaglandin Analog-Based Eyelash SerumOther

    Also called Eyelash Growth Serum, Prostaglandin Analog Eyelash Enhancer

    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.

Study groups in NCT06875687
Study groupRoleWhat they receive
Prostaglandin Analog-Based Eyelash Serum GroupExperimentalThis 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.
Receives: Other: Prostaglandin Analog-Based Eyelash Serum

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline and after six weeks of serum application

Secondary outcomes (3)

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

    Measured: Baseline and after six weeks

  2. Change in Ocular Hyperemia (Conjunctival and Ciliary Hyperemia) 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.

    Measured: Baseline and after six weeks

  3. Change in Eyelash Length and Thickness 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.

    Measured: Baseline and after six weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2025
  2. Study start15 Jan 2025
  3. Primary completion28 Feb 2025
  4. Study completion28 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06875687
Sponsor's protocol ID
USeville_2025_02
Acronym
EYESERUM
Status last verified
Mar 2025
First submitted
7 Mar 2025
Last updated
28 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 30666142

  • 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.

    PubMed 38572527

  • 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.

    PubMed 32308787

  • 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.

    PubMed 39579545

  • 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.

    PubMed 38475901

Questions about this trial

What is this clinical trial studying?

A study testing Prostaglandin Analog-Based Eyelash Serum in people with Dry Eye, run by University of Seville at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Tear Film Stability (A-NIBUT) After Six Weeks of Eyelash Serum Application (time frame: Baseline and after six weeks of serum application). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06875687, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.

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