Dry EyePhase 4NCT06555224
Role of Postoperative Lubrication in Cataract Surgery
A Phase 4 study testing Systane Hydration MDPF eye drops in people with Dry Eye, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
Cataract and dry eye are two conditions occurring frequently in the elderly. Several reports suggested a deterioration of dry eye after cataract surgery, causing a significant impact on patients' postoperative satisfaction as well as quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Systane Hydration MDPF eye drops
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- 22 Jun 2021to 18 Dec 2023
- Phase
- Phase 4
- 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
- Age older than 18 years
- Cataract surgery scheduled in one or both eyes
- Scheduled for monofocal or monofocal-toric IOL implantation
- OSDI lower than 14
- OSFI higher or equal to 0.3 - Group 1 and Group 2
- OSFI lower than 0.3 - Group 3
Who cannot join
- Presence of dry eye symptoms preoperatively
- Occurrence of complications during surgery
- Usage of systemic antibiotic therapy
- Any pathology of the ocular surface except dry eye disease (e.g. corneal scarring, cornea ectasia)
- Ocular surgery within prior 3 months
- Ocular injury within prior 3 months
Show all 12Show fewer
- Ocular herpes of eye or eyelid within prior 3 months
- Active ocular infection
- Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months
- Eyelid abnormalities that affect lid function
- Ocular surface abnormality that may compromise corneal integrity
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Postoperative Lubrication in Preventing Dry Eye After Cataract Surgery
Cataract and dry eye are two conditions occurring frequently in the elderly. Several reports suggested a deterioration of dry eye after cataract surgery, causing a significant impact on patients' postoperative satisfaction as well as quality of life. Recently, a novel index, assessing the risk of developing dry eye after cataract surgery in a non-dry eye population, was published; the so called - Ocular Surface Frailty Index (OSFI). This score utilizes 10 items including clinical ocular findings, medical history as well as environmental factors and grade the respective subject in low-risk- or high-risk group. Using the cutoff of 0.3, the rate of postoperative dry eye was 9,6% in the low-risk group and 50% in the high-risk group (p<0.001).
Systane Hydration MDPF eye drops (Alcon Research, Ltd., Fort, Worth, Texas, USA, a division of Novartis) is an artificial tear substitute based on the dual-polymer formula containing HP-Guar and hyaluronic acid. Previous studies found an increase in tear film stability and reduction of subjective complaints. In an animal model corneas treated with Systane Hydration showed the fastest re-epithelialization compared to other HA products supporting the beneficial role of HA-containing artificial tears in corneal wound healing.
Read more
The current study seeks to investigate if intensive lubrication, using Systane Hydration MDPF, in the postoperative phase of cataract surgery can reduce the rate of dry eye in the high-risk group. The findings will have a great impact how to identify these patients, to administer the adequate therapy, which might hinder development of dry eye related to cataract surgery.
The goal of this clinical trial is to learn if Systane Hydration MDPF eye drops (Alcon Research, Ltd., Fort, Worth, Texas, USA, a division of Novartis) works to treat prevent postoperative dry eye in adults undergoing cataract surgery. The main questions it aims to answer are:
- to investigate if intensive lubrication, using Systane Hydration MDPF, in the postoperative phase of cataract surgery can reduce the rate of dry eye in a high-risk group. The findings will have a great impact how to identify these patients, to administer the adequate therapy, which might hinder development of dry eye related to cataract surgery.
Participants will:
Take Systane Hydration MDPF eye drops 4x daily for 3 months additional to or just the standard of care medication (NSAID topical 2x daily for 4 weeks) after surgery Visit the clinic after 7 days, 1 month and 3 months after cataract surgery
- Conditions
- Dry Eye
- Being tested
- Systane Hydration MDPF eye 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 Hydration MDPF eye dropsDevice
Systane Hydration MDPF eye drops 4x daily for 3 months additional to routine medication after cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| High Risk Standard of Care | No intervention | OSFI >= 0.3, NSAID 2x daily for 4 weeks |
| High Risk Treatment Group | Experimental | OSFI >= 0.3, NSAID 2x daily for 4 weeks, Systane Hydration MDPF 4x daily for 3 months Receives: Device: Systane Hydration MDPF eye drops |
| Low Risk, Reference Group | No intervention | OSFI < 0.3, NSAID 2x daily for 4 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of dry eye symptoms defined by OSDI score >= 13 at 3 months visit
Measured: 3 months visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start22 Jun 2021
- Primary completion18 Dec 2023
- Study completion18 Dec 2023
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 EyeStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vienna Institute for Research in Ocular Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
- Investigators
- Oliver Findl, MD, Principal investigator, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555224
- Sponsor's protocol ID
- EK_21_098_0521
- Status last verified
- Aug 2024
- First submitted
- 12 Aug 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be availabe upon reasonable request.
Publications
Palkovits S, Schlatter A, Ruiss M, Fisus A, Bayer N, Kofler P, Findl O. Role of postoperative lubrication in preventing dry eye after cataract surgery in high- and low-risk patients stratified by ocular surface frailty index. PLoS One. 2025 Mar 26;20(3):e0312712. doi: 10.1371/journal.pone.0312712. eCollection 2025.
PubMed 40138387
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Postoperative Lubrication in Preventing Dry Eye After Cataract Surgery
- ClinicalTrials.gov ID
- NCT06555224
- Acronym / sponsor ID
- EK_21_098_0521
- Conditions
- Dry Eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 15 Aug 2024 (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.
Cataract and dry eye are two conditions occurring frequently in the elderly. Several reports suggested a deterioration of dry eye after cataract surgery, causing a significant impact on patients' postoperative satisfaction as well as quality of life. Recently, a novel index, assessing the risk of developing dry eye after cataract surgery in a non-dry eye population, was published; the so called - Ocular Surface Frailty Index (OSFI). This score utilizes 10 items including clinical ocular findings, medical history as well as environmental factors and grade the respective subject in low-risk- or high-risk group. Using the cutoff of 0.3, the rate of postoperative dry eye was 9,6% in the low-risk group and 50% in the high-risk group (p<0.001).
Systane Hydration MDPF eye drops (Alcon Research, Ltd., Fort, Worth, Texas, USA, a division of Novartis) is an artificial tear substitute based on the dual-polymer formula containing HP-Guar and hyaluronic acid. Previous studies found an increase in tear film stability and reduction of subjective complaints. In an animal model corneas treated with Systane Hydration showed the fastest re-epithelialization compared to other HA products supporting the beneficial role of HA-containing artificial tears in corneal wound healing.
The current study seeks to investigate if intensive lubrication, using Systane Hydration MDPF, in the postoperative phase of cataract surgery can reduce the rate of dry eye in the high-risk group. The findings will have a great impact how to identify these patients, to administer the adequate therapy, which might hinder development of dry eye related to cataract surgery.
The goal of this clinical trial is to learn if Systane Hydration MDPF eye drops (Alcon Research, Ltd., Fort, Worth, Texas, USA, a division of Novartis) works to treat prevent postoperative dry eye in adults undergoing cataract surgery. The main questions it aims to answer are:
- to investigate if intensive lubrication, using Systane Hydration MDPF, in the postoperative phase of cataract surgery can reduce the rate of dry eye in a high-risk group. The findings will have a great impact how to identify these patients, to administer the adequate therapy, which might hinder development of dry eye related to cataract surgery.
Participants will:
Take Systane Hydration MDPF eye drops 4x daily for 3 months additional to or just the standard of care medication (NSAID topical 2x daily for 4 weeks) after surgery Visit the clinic after 7 days, 1 month and 3 months after cataract surgery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Risk Standard of Care | No intervention | –OSFI >= 0.3, NSAID 2x daily for 4 weeks |
| High Risk Treatment Group | Experimental | Device: Systane Hydration MDPF eye dropsOSFI >= 0.3, NSAID 2x daily for 4 weeks, Systane Hydration MDPF 4x daily for 3 months |
| Low Risk, Reference Group | No intervention | –OSFI < 0.3, NSAID 2x daily for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age older than 18 years
- Cataract surgery scheduled in one or both eyes
- Scheduled for monofocal or monofocal-toric IOL implantation
- OSDI lower than 14
- OSFI higher or equal to 0.3 - Group 1 and Group 2
Key exclusion criteria (12 listed)
- Presence of dry eye symptoms preoperatively
- Occurrence of complications during surgery
- Usage of systemic antibiotic therapy
- Any pathology of the ocular surface except dry eye disease (e.g. corneal scarring, cornea ectasia)
- Ocular surgery within prior 3 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 |
|---|---|---|
| Systane Hydration MDPF eye dropsSystane Hydration MDPF eye drops 4x daily for 3 months additional to routine medication after cataract surgery | Device | High Risk Treatment Group |
Primary outcome
Rate of dry eye symptoms defined by OSDI score >= 13 at 3 months visit
Time frame: 3 months visit
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 15 Aug 2024.
- Derived from this study: PubMed 40138387Palkovits S, Schlatter A, Ruiss M, Fisus A, Bayer N, Kofler P, Findl O. Role of postoperative lubrication in preventing dry eye after cataract surgery in high- and low-risk patients stratified by ocular surface frailty index. PLoS One. 2025 Mar 26;20(3):e0312712. doi: 10.1371/journal.pone.0312712. eCollection 2025.
- Individual participant dataSharing planned: No. IPD will be availabe upon reasonable request.
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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.
Oliver Findl, MD principal investigator
Vienna Institute for Research in Ocular Surgery
1 site 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 Hydration MDPF eye drops in people with Dry Eye, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
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 6 inclusion and 12 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 15 Aug 2024. 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 Austria. 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?
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?
Rate of dry eye symptoms defined by OSDI score >= 13 at 3 months visit (time frame: 3 months visit). 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 NCT06555224, 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 15 Aug 2024.