Dry EyePhase 4NCT03848221
Direct Application of Systane Complete to Contact Lenses
A Phase 4 study testing Systane Complete and Sensitive Eyes Rewetting Drops in people with Dry Eye and Contact Lens Complication, run by University of Alabama at Birmingham at 3 sites in United States.
Trial summary
A common first line treatment for patients with dryness symptoms or contact lens discomfort is the application of artificial tears or rewetting drops, respectively. Rewetting drops are specifically formulated for use with contact lenses while artificial tears are indicated for dry eye. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye, Contact Lens Complication
- What is being tested?
- Systane Complete and Sensitive Eyes Rewetting Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 May 2019to 20 Oct 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Daily disposable contact lens wearers
- 20/30 visual acuity or better
- Self-report contact lens discomfort
- Contact Lens Dry Eye Questionnaire (CLDEQ)-8 scores ≥ 12
Who cannot join
- Other contact lens modalities/wear schedules (e.g., two week and monthly replacement CLs, gas permeable CLs)
- Non-compliant daily disposable contact lens wearers
- Systemic health conditions that alter tear film physiology (e.g., primary and secondary Sjögren's syndrome)
- History of ocular surgery within the past 12 months
- History of severe ocular trauma
- History of active ocular infection or inflammation
Show all 9Show fewer
- Isotretinoin-derivatives use
- Ocular medication use
- Pregnant or breast feeding
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Lindenhurst Eye Physicians & Surgeons, P.C.
Babylon, New York, 11702
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Southern College of Optometry
Memphis, Tennessee, 38104
About this study
Official title: Direct Application of Systane Complete to Contact Lenses for the Treatment of Contact Lens Discomfort
A common first line treatment for patients with dryness symptoms or contact lens discomfort is the application of artificial tears or rewetting drops, respectively. Rewetting drops are specifically formulated for use with contact lenses while artificial tears are indicated for dry eye. Modern rewetting drops and artificial tears have similar formulations with similar preservatives, preservatives that have been shown to be compatible with contact lenses. While rewetting drops and artificial tears are regulated under different U.S. Food \& Drug Administration policies, artificial tears are not specifically indicated for direct use with contact lenses. Nevertheless, clinicians commonly prescribe artificial tears to contact lens wearers likely because newer formulations of artificial tear have the potential to outperform available rewetting drops. The safety and efficacy of using artificial tears with contact lenses for the treatment of discomfort is supported by Caffery and Josephson and Ozkan and Papas who found that artificial tears significantly reduces dryness symptoms in contact lens wearers. Thus, the purpose of this study is to test the safety of directly applying a new artificial tear, Systane Complete, to the contact lens wearing eye and its ability to alleviate symptoms while wearing contact lenses during the day.
Read the detailed description
Soft contact lenses are the ideal vision correction choice for many patients because soft contact lenses allow patients to have better and less restricted vision, they allow for an increased ability to perform work tasks and play sports, and they provide patients with a better perceived cosmetic appearance compared to spectacle lenses. While millions of people worldwide benefit from contact lenses, many of these patients experience contact lens discomfort, which limits their wear time and in many instances eventually result in discontinuation of contact lens use. In fact, 21% to 64% of contact lens wearers permanently discontinue contact lens use because of ocular discomfort. Contact lens discomfort is currently defined as "a condition characterized by episodic or persistent adverse ocular sensations related to lens wear, either with or without visual disturbance, resulting from reduced compatibility between the contact lens and the ocular environment, which can lead to decreased wearing time and discontinuation of contact lens wear." Although contact lens discomfort may stem from the lens itself, a situation that can be corrected by such means as switching to an alternative material or wear schedule, contact lens discomfort more typically occurs from ocular surface disease.
A common first line treatment for patients with dryness symptoms or contact lens discomfort is the application of artificial tears or rewetting drops, respectively. Rewetting drops are specifically formulated for use with contact lenses while artificial tears are indicated for dry eye. Modern rewetting drops and artificial tears have similar formulations with similar preservatives, preservatives that have been shown to be compatible with contact lens use. While rewetting drops and artificial tears are regulated under different U.S. Food \& Drug Administration policies, artificial tears are not specifically indicated for use with contact lenses. Nevertheless, clinicians commonly prescribe artificial tears to contact lens wearers likely because newer formulations of artificial tear have the potential to outperform available rewetting drops (e.g., some artificial tears have lipid supplements that have the potential to restore the external tear lipid layer). The safe and effective use of artificial tears with contact lenses is supported by Caffery and Josephson and Ozkan and Papas who found that artificial tears significantly reduce dryness symptoms in contact lens wearers. However, the community currently lacks a rigorous scientific study aimed at understanding the utility of lipid-containing artificial tear (or rewetting drop) for alleviating contact lens discomfort while patients are wearing their contact lenses. Systane Complete, a new formulation of artificial tears, combines elements from both Systane Ultra (indicated for aqueous deficient dry eye) and Systane Balance (lipid-containing artificial tear indicated for evaporative dry eye). Thus, the purpose of this study is to test the safety of Systane Complete and its ability to alleviate contact lens discomfort during the day while subjects are wearing their contact lenses. This goal will be accomplished by randomizing subjects to either Systane Complete, a commercially available rewetting drop, or no treatment.
- Conditions
- Dry Eye, Contact Lens Complication
- Being tested
- Systane Complete, Sensitive Eyes Rewetting Drops
- Keywords
- Systane Complete, Dry Eye, Contact Lens Discomfort, Artificial Tears, Rewetting Drops
- 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.
Systane CompleteDrug
Systane Complete is an artificial tear.
Sensitive Eyes Rewetting DropsDrug
Sensitive Eyes Rewetting Drops is a rewetting drop.
| Study group | Role | What they receive |
|---|---|---|
| Systane Complete | Experimental | Subjects in this group will use Systane Complete before, during, and after contact lens use. Receives: Drug: Systane Complete |
| Sensitive Eyes Rewetting Drops | Active comparator | Subjects in this group will use Sensitive Eyes Rewetting Drops before, during, and after contact lens use. Receives: Drug: Sensitive Eyes Rewetting Drops |
| No Treatment | No intervention | Subjects in this group will not be allowed to use artificial tears or rewetting drops during the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Ocular Surface Damage as Measured by the Brien Holden Vision Institute (BHVI Grading Scale) at Two Weeks
The Corneal Staining Scores are measured by the BHVI grading scale. The grading scales are a quick reference to the key signs associated with contact lens related inflammation and infection. Used as a reference tool in the clinic, they provide a guide for determining how much normal ocular appearance has changed in a patient, and can help inform clinical management decisions. The range of the scores are: 0-4 in five regions (total sum score = 20). A lower score indicates a better outcome.
Measured: 2 Weeks
Secondary outcomes (1)
Identifying Contact Lens (CL) Participants With Dry Eye Disease (DED), as Measured by the Contact Lens Dry Eye Questionnaire-4 Items (CLDEQ-4) Between Two Weeks and Baseline.
The CLDEQ-4 is a contact lens specific symptoms survey; range = 0-18 with 18 being most symptomatic.
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start28 May 2019
- Primary completion20 Oct 2019
- Study completion20 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Investigator Masked, Randomized, Clinical Trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Principal investigator, Andrew Pucker, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848221
- Sponsor's protocol ID
- 000523741
- Status last verified
- Oct 2020
- First submitted
- 19 Feb 2019
- Last updated
- 8 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual subject data.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Application of Systane Complete to Contact Lenses for the Treatment of Contact Lens Discomfort
- ClinicalTrials.gov ID
- NCT03848221
- Acronym / sponsor ID
- 000523741
- Conditions
- Dry Eye, Contact Lens Complication
- Keywords
- Systane Complete, Dry Eye, Contact Lens Discomfort, Artificial Tears, Rewetting Drops
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 28 May 2019 (actual)
- Primary completion
- 20 Oct 2019 (actual)
- Study completion
- 20 Oct 2019 (actual)
- First posted
- 20 Feb 2019 (actual)
- Results
- Posted 27 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A common first line treatment for patients with dryness symptoms or contact lens discomfort is the application of artificial tears or rewetting drops, respectively. Rewetting drops are specifically formulated for use with contact lenses while artificial tears are indicated for dry eye. Modern rewetting drops and artificial tears have similar formulations with similar preservatives, preservatives that have been shown to be compatible with contact lenses. While rewetting drops and artificial tears are regulated under different U.S. Food \& Drug Administration policies, artificial tears are not specifically indicated for direct use with contact lenses. Nevertheless, clinicians commonly prescribe artificial tears to contact lens wearers likely because newer formulations of artificial tear have the potential to outperform available rewetting drops. The safety and efficacy of using artificial tears with contact lenses for the treatment of discomfort is supported by Caffery and Josephson and Ozkan and Papas who found that artificial tears significantly reduces dryness symptoms in contact lens wearers. Thus, the purpose of this study is to test the safety of directly applying a new artificial tear, Systane Complete, to the contact lens wearing eye and its ability to alleviate symptoms while wearing contact lenses during the day.
Detailed description
Soft contact lenses are the ideal vision correction choice for many patients because soft contact lenses allow patients to have better and less restricted vision, they allow for an increased ability to perform work tasks and play sports, and they provide patients with a better perceived cosmetic appearance compared to spectacle lenses. While millions of people worldwide benefit from contact lenses, many of these patients experience contact lens discomfort, which limits their wear time and in many instances eventually result in discontinuation of contact lens use. In fact, 21% to 64% of contact lens wearers permanently discontinue contact lens use because of ocular discomfort. Contact lens discomfort is currently defined as "a condition characterized by episodic or persistent adverse ocular sensations related to lens wear, either with or without visual disturbance, resulting from reduced compatibility between the contact lens and the ocular environment, which can lead to decreased wearing time and discontinuation of contact lens wear." Although contact lens discomfort may stem from the lens itself, a situation that can be corrected by such means as switching to an alternative material or wear schedule, contact lens discomfort more typically occurs from ocular surface disease.
A common first line treatment for patients with dryness symptoms or contact lens discomfort is the application of artificial tears or rewetting drops, respectively. Rewetting drops are specifically formulated for use with contact lenses while artificial tears are indicated for dry eye. Modern rewetting drops and artificial tears have similar formulations with similar preservatives, preservatives that have been shown to be compatible with contact lens use. While rewetting drops and artificial tears are regulated under different U.S. Food \& Drug Administration policies, artificial tears are not specifically indicated for use with contact lenses. Nevertheless, clinicians commonly prescribe artificial tears to contact lens wearers likely because newer formulations of artificial tear have the potential to outperform available rewetting drops (e.g., some artificial tears have lipid supplements that have the potential to restore the external tear lipid layer). The safe and effective use of artificial tears with contact lenses is supported by Caffery and Josephson and Ozkan and Papas who found that artificial tears significantly reduce dryness symptoms in contact lens wearers. However, the community currently lacks a rigorous scientific study aimed at understanding the utility of lipid-containing artificial tear (or rewetting drop) for alleviating contact lens discomfort while patients are wearing their contact lenses. Systane Complete, a new formulation of artificial tears, combines elements from both Systane Ultra (indicated for aqueous deficient dry eye) and Systane Balance (lipid-containing artificial tear indicated for evaporative dry eye). Thus, the purpose of this study is to test the safety of Systane Complete and its ability to alleviate contact lens discomfort during the day while subjects are wearing their contact lenses. This goal will be accomplished by randomizing subjects to either Systane Complete, a commercially available rewetting drop, or no treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Investigator Masked, Randomized, Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Systane Complete | Experimental | Drug: Systane CompleteSubjects in this group will use Systane Complete before, during, and after contact lens use. |
| Sensitive Eyes Rewetting Drops | Active comparator | Drug: Sensitive Eyes Rewetting DropsSubjects in this group will use Sensitive Eyes Rewetting Drops before, during, and after contact lens use. |
| No Treatment | No intervention | –Subjects in this group will not be allowed to use artificial tears or rewetting drops during the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Daily disposable contact lens wearers
- 20/30 visual acuity or better
- Self-report contact lens discomfort
- Contact Lens Dry Eye Questionnaire (CLDEQ)-8 scores ≥ 12
Key exclusion criteria (9 listed)
- Other contact lens modalities/wear schedules (e.g., two week and monthly replacement CLs, gas permeable CLs)
- Non-compliant daily disposable contact lens wearers
- Systemic health conditions that alter tear film physiology (e.g., primary and secondary Sjögren's syndrome)
- History of ocular surgery within the past 12 months
- History of severe ocular trauma
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 |
|---|---|---|
| Systane CompleteSystane Complete is an artificial tear. | Drug | Systane Complete |
| Sensitive Eyes Rewetting DropsSensitive Eyes Rewetting Drops is a rewetting drop. | Drug | Sensitive Eyes Rewetting Drops |
Primary outcome
Difference in Ocular Surface Damage as Measured by the Brien Holden Vision Institute (BHVI Grading Scale) at Two Weeks
Time frame: 2 Weeks
The Corneal Staining Scores are measured by the BHVI grading scale. The grading scales are a quick reference to the key signs associated with contact lens related inflammation and infection. Used as a reference tool in the clinic, they provide a guide for determining how much normal ocular appearance has changed in a patient, and can help inform clinical management decisions. The range of the scores are: 0-4 in five regions (total sum score = 20). A lower score indicates a better outcome.
1 secondary outcome
Identifying Contact Lens (CL) Participants With Dry Eye Disease (DED), as Measured by the Contact Lens Dry Eye Questionnaire-4 Items (CLDEQ-4) Between Two Weeks and Baseline.
Time frame: 2 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is no plan to share individual subject data.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Systane Complete and Sensitive Eyes Rewetting Drops in people with Dry Eye and Contact Lens Complication, run by University of Alabama at Birmingham at 3 sites 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 4 inclusion and 9 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 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Difference in Ocular Surface Damage as Measured by the Brien Holden Vision Institute (BHVI Grading Scale) at Two Weeks (time frame: 2 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2020.