Dry Eye Disease (DED)NCT07904728
Treating Contact Lens Discomfort With Cyclosporine 0.1% Ophthalmic Solution
A study testing Cyclosporine 0.1% Ophthalmic Solution in people with Dry Eye Disease (DED) and Contact Lens Discomfort (CLD), run by Ocular Aesthetics, LLC dba Ocular Clinical Trials at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease (DED), Contact Lens Discomfort (CLD)
- What is being tested?
- Cyclosporine 0.1% Ophthalmic Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2026to 15 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ocular Clinical Trials
Houston, Texas, 77027
About this study
Official title: A Clinical Evaluation of Treating Contact Lens Discomfort With Water-Free Cyclosporine 0.1% Ophthalmic Solution
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.
Read the detailed description
This is a 12-week, three-visit study aims to evaluate whether VEVYE, a water-free 0.1% cyclosporine ophthalmic solution indicated for the treatment of dry eye disease (DED), can alleviate DED symptoms and improve contact lens (CL) comfort. The open-label, prospective clinical trial will recruit 50 individuals who meet the study's eligibility criteria.
- Being tested
- Cyclosporine 0.1% Ophthalmic Solution
- Keywords
- Cyclosporine, VEVYE, Dry Eye Disease, Contact Lens Discomfort
- 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.
Cyclosporine 0.1% Ophthalmic SolutionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| VEVYE (water-free cyclosporine 0.1% ophthalmic solution) | Experimental | 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. Receives: Drug: Cyclosporine 0.1% Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
Scores range from 0-37. Lower scores indicate better comfort.
Measured: Baseline compared to 12 weeks.
Secondary outcomes (3)
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
Scores range from 0-37. Lower scores indicate better comfort.
Measured: Baseline compared to 2 weeks.
Eye Dryness Scores, Fluctuating Vision, OVERALL Contact Lens Discomfort, and END of DAY Contact Lens Discomfort
0-100 Visual Analog Scales (VAS) with lower scores being better comfort.
Measured: 2 weeks and 12 weeks compared to baseline.
Corneal Fluorescein Staining
0-15 scale as measured with the NEI Scale. Smaller scores represent better corneal health.
Measured: 2 weeks and 12 weeks compared to Baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start25 Aug 2026
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Individuals who qualify for the study will be provided with VEVYE, which is a water-free 0.1% cyclosporine ophthalmic solution indicated for treatment of dry eye disease. The drug will be dosed twice each day in each eye before and after contact lens use.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ocular Aesthetics, LLC dba Ocular Clinical Trials
- Sponsor type
- University, hospital or other
- Collaborators
- Harrow Eye, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904728
- Sponsor's protocol ID
- IRB ID 17118
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pucker AD, Tichenor AA. A Review of Contact Lens Dropout. Clin Optom (Auckl). 2020 Jun 25;12:85-94. doi: 10.2147/OPTO.S198637. eCollection 2020.
PubMed 32612404
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of Treating Contact Lens Discomfort With Water-Free Cyclosporine 0.1% Ophthalmic Solution
- ClinicalTrials.gov ID
- NCT07904728
- Acronym / sponsor ID
- IRB ID 17118
- Keywords
- Cyclosporine, VEVYE, Dry Eye Disease, Contact Lens Discomfort
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ocular Aesthetics, LLC dba Ocular Clinical TrialsUniversity, hospital or other
- Collaborators
- Harrow Eye, LLC
- Study start
- 25 Aug 2026 (actual)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a 12-week, three-visit study aims to evaluate whether VEVYE, a water-free 0.1% cyclosporine ophthalmic solution indicated for the treatment of dry eye disease (DED), can alleviate DED symptoms and improve contact lens (CL) comfort. The open-label, prospective clinical trial will recruit 50 individuals who meet the study's eligibility criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Individuals who qualify for the study will be provided with VEVYE, which is a water-free 0.1% cyclosporine ophthalmic solution indicated for treatment of dry eye disease. The drug will be dosed twice each day in each eye before and after contact lens use.
| Arm | Type | Receives |
|---|---|---|
| VEVYE (water-free cyclosporine 0.1% ophthalmic solution) | Experimental | Drug: Cyclosporine 0.1% Ophthalmic SolutionParticipants will be treated with VEVYE (water-free cyclosporine 0.1% ophthalmic solution) twice per day in each eye before and after contact lens use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclosporine 0.1% Ophthalmic SolutionParticipants will be treated with VEVYE (water-free cyclosporine 0.1% ophthalmic solution) twice per day in each eye before and after contact lens use. | Drug | VEVYE (water-free cyclosporine 0.1% ophthalmic solution) |
Primary outcome
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
Time frame: Baseline compared to 12 weeks.
Scores range from 0-37. Lower scores indicate better comfort.
3 secondary outcomes
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
Time frame: Baseline compared to 2 weeks.
Eye Dryness Scores, Fluctuating Vision, OVERALL Contact Lens Discomfort, and END of DAY Contact Lens Discomfort
Time frame: 2 weeks and 12 weeks compared to baseline.
Corneal Fluorescein Staining
Time frame: 2 weeks and 12 weeks compared to Baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 32612404Pucker AD, Tichenor AA. A Review of Contact Lens Dropout. Clin Optom (Auckl). 2020 Jun 25;12:85-94. doi: 10.2147/OPTO.S198637. eCollection 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyclosporine 0.1% Ophthalmic Solution in people with Dry Eye Disease (DED) and Contact Lens Discomfort (CLD), run by Ocular Aesthetics, LLC dba Ocular Clinical Trials at 1 site in United States.
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 14 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 29 Oct 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanesa Flores, OD (713-838-2020, info@ocularclinicaltrials.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) (time frame: Baseline compared to 12 weeks.). 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 NCT07904728, which also lists 1 linked publication.
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 29 Oct 2026.