Dry Eye SyndromesNCT02956083
The Effect of Tear Supplements on Contact Lens Comfort
A study testing Systane Balance eye drops, Systane Contacts eye drops and saline in people with Dry Eye Syndromes and Meibomian Gland Dysfunction, run by University of the Incarnate Word.
Trial summary
The primary goal of this investigation is to determine if lipid based artificial tear supplementation has an impact on contact lens discomfort (CLD). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Dry Eye Syndromes, Meibomian Gland Dysfunction
- What is being tested?
- Systane Balance eye drops, Systane Contacts eye drops and saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Jul 2015
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients complaining of contact lens associated discomfort
Who cannot join
- Patients who do not have contact lens discomfort; patients who have active inflammation or infection of the anterior segment of the eyes.
About this study
The primary goal of this investigation is to determine if lipid based artificial tear supplementation has an impact on contact lens discomfort (CLD).
Read the detailed description
Contact lens discomfort (CLD) is the most common cause of discontinuing contact lens wear. Despite years of research and innovations in technology, CLD remains highly prevalent, and thus it is a major concern for patients and practitioners. Studies suggest that meibomian gland dysfunction (MGD) is a cause of CLD. Several lipid-based artificial tears have recently been designed to address dry eye associated with MGD. In this study, the investigators examine if the benefits of lipid based artificial tears extend to improving contact lens comfort. Studies have demonstrated some usefulness of non-lipid based tear supplements in the management of contact lens discomfort. However, the relief was moderate and short-term. To date, no study has examined the impact of lipid based artificial tears on contact lens discomfort. In this study, the investigators will address this gap in knowledge.
- Conditions
- Dry Eye Syndromes, Meibomian Gland Dysfunction
- Being tested
- Systane Balance eye drops, Systane Contacts eye drops, saline
- Medical subject headings
- Dry Eye Syndromes, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systane Balance eye dropsOther
Propylene Glycol 0.6% Over the counter lipid based artificial tears.
Systane Contacts eye dropsOther
Hydroxypropyl methycellulose over the counter non-lipid based artificial tears
salineOther
Saline - no brand name
| Study group | Role | What they receive |
|---|---|---|
| Lipid based artificial tears | Active comparator | Patients use lipid based artificial tears Receives: Other: Systane Balance eye drops |
| Non-lipid based artificial tears | Active comparator | patients use non-lipid based artificial tears Receives: Other: Systane Contacts eye drops |
| Saline | Placebo comparator | patients use saline Receives: Other: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contact Lens Discomfort Questionnaire
CLDEQ Questionnaire will be used to quantify contact lens discomfort
Measured: 1 months
Secondary outcomes (1)
Fluorescein tear break-up time
Fluorescein will be instilled in the conjunctival sac to assess tear break-up time
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study startJul 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Incarnate Word
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Srihari Narayanan, OD, PhD, Principal investigator, University of the Incarnate Word
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956083
- Sponsor's protocol ID
- 14-04-013
- Status last verified
- Nov 2016
- First submitted
- 1 Nov 2016
- Last updated
- 4 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tear Supplements on Contact Lens Comfort
- ClinicalTrials.gov ID
- NCT02956083
- Acronym / sponsor ID
- 14-04-013
- Conditions
- Dry Eye Syndromes, Meibomian Gland Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of the Incarnate WordUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 4 Nov 2016 (estimated)
- 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.
The primary goal of this investigation is to determine if lipid based artificial tear supplementation has an impact on contact lens discomfort (CLD).
Detailed description
Contact lens discomfort (CLD) is the most common cause of discontinuing contact lens wear. Despite years of research and innovations in technology, CLD remains highly prevalent, and thus it is a major concern for patients and practitioners. Studies suggest that meibomian gland dysfunction (MGD) is a cause of CLD. Several lipid-based artificial tears have recently been designed to address dry eye associated with MGD. In this study, the investigators examine if the benefits of lipid based artificial tears extend to improving contact lens comfort. Studies have demonstrated some usefulness of non-lipid based tear supplements in the management of contact lens discomfort. However, the relief was moderate and short-term. To date, no study has examined the impact of lipid based artificial tears on contact lens discomfort. In this study, the investigators will address this gap in knowledge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lipid based artificial tears | Active comparator | Other: Systane Balance eye dropsPatients use lipid based artificial tears |
| Non-lipid based artificial tears | Active comparator | Other: Systane Contacts eye dropspatients use non-lipid based artificial tears |
| Saline | Placebo comparator | Other: salinepatients use saline |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients complaining of contact lens associated discomfort
Key exclusion criteria (1 listed)
- Patients who do not have contact lens discomfort; patients who have active inflammation or infection of the anterior segment of the eyes.
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 Balance eye dropsPropylene Glycol 0.6% Over the counter lipid based artificial tears. | Other | Lipid based artificial tears |
| Systane Contacts eye dropsHydroxypropyl methycellulose over the counter non-lipid based artificial tears | Other | Non-lipid based artificial tears |
| salineSaline - no brand name | Other | Saline |
Primary outcome
Contact Lens Discomfort Questionnaire
Time frame: 1 months
CLDEQ Questionnaire will be used to quantify contact lens discomfort
1 secondary outcome
Fluorescein tear break-up time
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2016.
- 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. This study is not recruiting at the moment.
Srihari Narayanan, OD, PhD principal investigator
University of the Incarnate Word
Questions about this trial
What is this clinical trial studying?
A study testing Systane Balance eye drops, Systane Contacts eye drops and saline in people with Dry Eye Syndromes and Meibomian Gland Dysfunction, run by University of the Incarnate Word.
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 1 inclusion and 1 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 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Contact Lens Discomfort Questionnaire (time frame: 1 months). 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 4 Nov 2016.