Dry Eye DiseaseNCT05056233
Systane Hydration in Subjects Undergoing Cataract Surgery
A study testing Systane Hydration lubricant eye drops in people with Dry Eye Disease and Cataract, run by Alcon Research at 1 site in Spain.
Trial summary
The primary objective of this study is to demonstrate reduced corneal staining with use of Systane Hydration among subjects with dry eye disease (DED) undergoing routine cataract removal and monofocal intraocular lens (IOL) implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease, Cataract
- What is being tested?
- Systane Hydration lubricant eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- 18 Jan 2022to 12 Jan 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Seeking routine (age-related) cataract extraction with monofocal intraocular lens implantation;
- Able to provide informed consent;
- Willing and able to attend all study visits and comply with treatment;
- Have dry eyes per dry eye questionnaire.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Subjects who use of ocular drugs, other than the test article (for treatment group only) and other standard of care postoperative medications, during the study;
- History of intraocular or corneal surgery in the study eye;
- Use of artificial tears, steroids, or other medications as specified in the protocol;
- Clinically significant corneal scarring;
- Corneal degeneration, retinal degeneration or other ocular pathology as specified in the protocol.
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to demonstrate reduced corneal staining with use of Systane Hydration among subjects with dry eye disease (DED) undergoing routine cataract removal and monofocal intraocular lens (IOL) implantation.
Read the detailed description
Subjects will attend 6 scheduled study visits for an individual duration of participation of 6 weeks. One eye (study eye) will be followed.
- Conditions
- Dry Eye Disease, Cataract
- Being tested
- Systane Hydration lubricant eye drops
- Medical subject headings
- Dry Eye Syndromes, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systane Hydration lubricant eye dropsOther
Also called Systane Hydration® Ophthalmic Solution
Sterile solution indicated for the temporary relief of burning and irritation due to dryness of the eye
| Study group | Role | What they receive |
|---|---|---|
| Systane Hydration | Experimental | Systane Hydration lubricant eye drops dosed 4 times a day for 6 weeks (2 weeks prior to surgery and 4 weeks post surgery), with investigator defined post-operative standard of care Receives: Other: Systane Hydration lubricant eye drops |
| No Treatment | No intervention | Investigator defined post-operative standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal staining
The National Eye Institute (NEI) grading scale will be used to evaluate the five corneal regions: Superior, inferior, central, temporal and nasal. Each region will be graded on a 0-3 scale, where 0 = normal (no staining), 1 = mild/superficial stippling micropunctate staining, 2 = moderate/macropunctate staining with some coalescent areas, and 3 = severe/numerous coalescent macropunctate areas and/or patches. The regions will be summed for a resultant overall score of 0 to 15.
Measured: Up to Day 30 post-operative
Secondary outcomes (4)
DEQ-5 Score
The Dry Eye Questionnaire-5 (DEQ-5) is a patient-reported outcome measures questionnaire designed to assess symptoms of dry eye disease. Subjects will respond to 5 questions using a 0-4 Likert-type scale, for a resultant overall score of 0 (best) to 20 (worst).
Measured: Up to Day 30 post-operative
Ocular Comfort Questionnaire Score: My eyes are comfortable
Subjects will provide a comfort score (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree) to the following question: "My eyes are comfortable."
Measured: Up to Day 30 post-operative
Ocular Comfort Questionnaire Score: At the end of the day, my eyes feel comfortable
Subjects will provide a comfort score (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree) to the following question: "At the end of the day, my eyes feel comfortable."
Measured: Up to Day 30 post-operative
Ocular Comfort Questionnaire Score: My eyes are comfortable all day long
Subjects will provide a comfort score (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree) to the following question: "My eyes are comfortable all day long."
Measured: Up to Day 30 post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start18 Jan 2022
- Primary completion12 Jan 2023
- Study completion12 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sr. Clinical Trial Lead, CDMA Surgical, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056233
- Sponsor's protocol ID
- DER646-P001
- Status last verified
- Feb 2023
- First submitted
- 15 Sep 2021
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systane Hydration in Subjects Undergoing Cataract Surgery
- ClinicalTrials.gov ID
- NCT05056233
- Acronym / sponsor ID
- DER646-P001
- Conditions
- Dry Eye Disease, Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 12 Jan 2023 (actual)
- Study completion
- 12 Jan 2023 (actual)
- First posted
- 24 Sep 2021 (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.
The primary objective of this study is to demonstrate reduced corneal staining with use of Systane Hydration among subjects with dry eye disease (DED) undergoing routine cataract removal and monofocal intraocular lens (IOL) implantation.
Detailed description
Subjects will attend 6 scheduled study visits for an individual duration of participation of 6 weeks. One eye (study eye) will be followed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systane Hydration | Experimental | Other: Systane Hydration lubricant eye dropsSystane Hydration lubricant eye drops dosed 4 times a day for 6 weeks (2 weeks prior to surgery and 4 weeks post surgery), with investigator defined post-operative standard of care |
| No Treatment | No intervention | –Investigator defined post-operative standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Seeking routine (age-related) cataract extraction with monofocal intraocular lens implantation;
- Able to provide informed consent;
- Willing and able to attend all study visits and comply with treatment;
- Have dry eyes per dry eye questionnaire.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (6 listed)
- Subjects who use of ocular drugs, other than the test article (for treatment group only) and other standard of care postoperative medications, during the study;
- History of intraocular or corneal surgery in the study eye;
- Use of artificial tears, steroids, or other medications as specified in the protocol;
- Clinically significant corneal scarring;
- Corneal degeneration, retinal degeneration or other ocular pathology as specified in the protocol.
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 Hydration lubricant eye dropsAlso: Systane Hydration® Ophthalmic SolutionSterile solution indicated for the temporary relief of burning and irritation due to dryness of the eye | Other | Systane Hydration |
Primary outcome
Corneal staining
Time frame: Up to Day 30 post-operative
The National Eye Institute (NEI) grading scale will be used to evaluate the five corneal regions: Superior, inferior, central, temporal and nasal. Each region will be graded on a 0-3 scale, where 0 = normal (no staining), 1 = mild/superficial stippling micropunctate staining, 2 = moderate/macropunctate staining with some coalescent areas, and 3 = severe/numerous coalescent macropunctate areas and/or patches. The regions will be summed for a resultant overall score of 0 to 15.
4 secondary outcomes
DEQ-5 Score
Time frame: Up to Day 30 post-operative
Ocular Comfort Questionnaire Score: My eyes are comfortable
Time frame: Up to Day 30 post-operative
Ocular Comfort Questionnaire Score: At the end of the day, my eyes feel comfortable
Time frame: Up to Day 30 post-operative
Ocular Comfort Questionnaire Score: My eyes are comfortable all day long
Time frame: Up to Day 30 post-operative
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 22 Feb 2023.
- 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.
Sr. Clinical Trial Lead, CDMA Surgical study director
Alcon Research, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systane Hydration lubricant eye drops in people with Dry Eye Disease and Cataract, run by Alcon Research 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 5 inclusion and 6 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 22 Feb 2023. 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?
Corneal staining (time frame: Up to Day 30 post-operative). 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 22 Feb 2023.