Recruiting

VEVYE

Sponsor:

Ocular Aesthetics, LLC dba Ocular Clinical Trials

Code:

NCT07904728

Conditions

Dry Eye Disease (DED)

Contact Lens Discomfort (CLD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cyclosporine 0.1% Ophthalmic Solution

Study Details

Brief summary:

Of the 140 million contact lens (CL) wearers worldwide, most wear soft contact lenses. Despite major improvements in contact lens care, nearly 20% of wearers stop using lenses, with contact lens discomfort (CLD) being the main reason. This study aims to determine whether VEVYE, a water-free 0.1% cyclosporine ophthalmic solution indicated for the treatment of DED, can improve contact lens comfort in people with dry eye disease.

Conditions

Dry Eye Disease (DED)

Contact Lens Discomfort (CLD)

Study ID

NCT07904728

Start date

Aug 25, 2026

Status verified date

Oct, 2026

Completion date

Apr 15, 2027

Anticipated

Primary completion date

Mar 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult male and female subjects of any race or ethnicity who are ≥18 years of age.
  • Best corrected CL visual acuity of 0.3 Logarithm of the Minimum Angle of Resolution (logMAR) or better in both eyes (Snellen equivalent 20/40).
  • Daily, soft, frequent replacement CL wearer (daily disposable, bi-weekly, or monthly CLs).
  • Contact Lens Dry Eye Questionnaire (CLDEQ)-8 scores (CLDEQ-8 scores ≥ 12).
  • A VAS score of ≥40 for Eye Dryness and End of Day Contact Lens Discomfort.
  • A corneal fluorescein staining score on the original NEI scale of ≥3.
  • Habitually wears soft CLs for a minimum of 5 days per week for 6 hours per day during the month prior to enrollment.
  • Willing to maintain habitual CL wear routine for the 3 months duration of the study.20
  • Willing to only use VEVYE for dry eye treatment for the 3 months duration of the study.
  • Willing to use VEVYE twice a day even if CL is not worn for that day.
  • Habitual CLs have an acceptable fit (good centration, movement, and coverage).20
  • Willing to not use any lipid containing artificial tear (AT) for the 3 months duration of the study.
  • Willing to only use non-lipid containing preservative free artificial tear for the 3 months duration of the study if needed, but no more than 4 times per day; also must agree to record frequency of daily AT use if applicable.
  • Willing to record daily time for CL application, removal, and VEVYE applications.

Exclusion Criteria:

  • Any history of VEVYE use within 6 months of enrollment.
  • Are currently an overnight CL wearer.
  • Are currently wearing rigid gas permeable CLs, scleral CL, hybrid CLs, or custom soft CLs.
  • Have known systemic health conditions that are known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome).
  • Have a history of ocular surgery within the past 12 months.
  • Have a history of viral eye disease.
  • Have a history of severe ocular trauma, active ocular infection or inflammation.
  • Have ever used or are currently using isotretinoin-derivates (e.g., Accutane).
  • Are currently taking ocular medications or plan to during the study (e.g., DED, glaucoma, etc.).
  • Are currently taking systemic medications that have anticholinergic properties (e.g., antihistamines, antianxiety, antidepressants, etc.) and use is anticipated to change during the course of the study (anticipated stable use of these drugs is allowed).
  • Subjects with meibomian gland blockage or significant atrophy (e.g., severe MGD). Currently having >50% blockage of Meibomian glands in more than two eyelids.
  • Having blepharitis and/or demodex blepharitis > grade 2.
  • Have had a physical meibomian gland dysfunction treatment within 3 month of enrollment (iLux, Lipiflow, Radio Frequency and IPL with manual expressions, microblepharoexfoliation etc.).
  • Have used a prescription DED or ocular surface disease medication in the last 1 month.
  • Have used Lacrifill withing 1 month of enrollment.
  • Have a condition or in a situation, which in the examiner's opinion, may put the subject at significant risk, may confound the study results, or may significantly interfere with their participation.
  • Are pregnant or breast feeding or plan to get pregnant. Note: To participate in this study, subjects of child bearing potential must be on an adequate form of birth control, which can include but not limited to: Barrier methods; Hormonal contraceptives; Surgical sterilization (tubal ligation > 5 years ago, hysterectomy); Intrauterine device; Vasectomized male partner must be sole partner and procedure performed >1 year prior to study participation; Abstinence.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VEVYE (water-free cyclosporine 0.1% ophthalmic solution)

Participants will be treated with VEVYE (water-free cyclosporine 0.1% ophthalmic solution) twice per day in each eye before and after contact lens use.

Interventions

Cyclosporine 0.1% Ophthalmic Solution

Participants will be treated with VEVYE (water-free cyclosporine 0.1% ophthalmic solution) twice per day in each eye before and after contact lens use.

Primary outcome measure

  • Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) [ Time Frame: Baseline compared to 12 weeks. ]

Central Contacts and Locations

Central contacts

Vanesa Flores, OD

713-838-2020info@ocularclinicaltrials.com

Locations

Ocular Clinical Trials

Recruiting

Houston, Texas, United States, 77027

More Information

Sponsor

Ocular Aesthetics, LLC dba Ocular Clinical Trials

Last update posted

Oct 29, 2026

Last verified

Oct, 2026

Keywords

  • Cyclosporine
  • VEVYE
  • Dry Eye Disease
  • Contact Lens Discomfort

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-30. This information was provided to ClinicalTrials.gov by Ocular Aesthetics, LLC dba Ocular Clinical Trials on 2026-10-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.