OphthalmologyPhase 4NCT06886373
Optimizing the Ocular Surface With Systane COMPLETE Pre- and Post-operatively in Patients With Dry Eye Planning for Cataract Surgery: An Extension Study of Optimizing the Ocular Surface With Systane COMPLETE in Patients With Dry Eye Planning for Cataract Surgery
A Phase 4 study testing Systane Complete in people with Ophthalmology, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Compare the corneal astigmatism data before and after the use of Systane COMPLETE to evaluate its impact on predicting changes in postoperative residual astigmatism, as well as the effects of using or not using Systane COMPLETE on preoperative and postoperative Ocular Surface Disease Index (OSDI) scores and… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Ophthalmology
- What is being tested?
- Systane Complete
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Mar 2025to 31 Dec 2027
- Phase
- Phase 4
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cataract patients aged between 20 and 85 years.
- Patients with normal cognitive function who are able to complete the dry eye questionnaire (with - responses recorded by the research team) and are willing to undergo phacoemulsification and intraocular lens implantation under topical anesthesia.
Who cannot join
- Unable to answer the questions in the dry eye survey.
- Ocular trauma or ocular surgery in the planned surgical eye, active ocular infection, and obvious abnormalities in ocular surface or eyelid margins other than MGD cause decreased visual acuity other than cataracts.
- Dry eye signs: Corneal Fluorescein Staining CFS (+) to exclude any corneal abnormalities or epithelial defect.
- Systemic drug use, including tetracycline derivatives, antihistamines, and isotretinoin.
- Using dry eye medication at screening stage.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Chiun Ho Hou, Ph.D, +88623123456 ext. 262131, chiunhohou@gmail.com
About this study
Compare the corneal astigmatism data before and after the use of Systane COMPLETE to evaluate its impact on predicting changes in postoperative residual astigmatism, as well as the effects of using or not using Systane COMPLETE on preoperative and postoperative Ocular Surface Disease Index (OSDI) scores and Non-Invasive Tear Break-Up Time (NITBUT).
Read the detailed description
STUDY OBJECTIVE： Compare the corneal astigmatism data before and after the use of Systane COMPLETE to evaluate its impact on predicting changes in postoperative residual astigmatism.
Compare the effects of using or not using Systane COMPLETE on preoperative and postoperative Ocular Surface Disease Index (OSDI) scores and Non-Invasive Tear Break-Up Time (NITBUT).
Background Cataract surgery is one of the most common and successful ophthalmic surgeries worldwide. However, cataract surgery can induce or exacerbate the severity of dry eye, leading to increased postoperative discomfort for patients. Additionally, undiagnosed preoperative dry eye can affect the accuracy of corneal astigmatism measurements, potentially impacting the astigmatic correction power of toric intraocular lenses used during surgery.
While general moisturizing artificial tears have been shown to significantly reduce postoperative ocular discomfort and tear film instability, it is notable that up to 50% of patients undergoing refractive or cataract surgery exhibit abnormalities in the tear film lipid layer, meeting the diagnostic criteria for meibomian gland dysfunction (MGD).
Given this, the application of lipid-containing nano-emulsion artificial tears before and after cataract surgery presents an unexplored opportunity to address two critical issues: reducing errors in corneal astigmatism measurements and alleviating dry eye symptoms induced by cataract surgery. This remains a topic worthy of investigation, as no existing studies have thoroughly examined these aspects.
Methods This study is an extension of the "Optimizing the Ocular Surface with Systane COMPLETE in Patients with Dry Eye Planning for Cataract Surgery" trial (Research Ethics Committee Approval Number: 202311109MIPD), hereinafter referred to as the OOSSCC trial.
The original OOSSCC trial began recruitment in May 2024 and focuses on analyzing patients with dry eye symptoms scheduled for cataract surgery. The trial evaluates the changes in corneal anterior surface astigmatism measurements, Ocular Surface Disease Index (OSDI) scores, and Non-Invasive Tear Break-Up Time (NITBUT) before and after one month of preoperative treatment with Systane COMPLETE.This trial will extend the study period to one month post-surgery and will be divided into two parts:
Experimental group:
This part extends the use of Systane COMPLETE for participants in the original OOSSCC trial to one month post-surgery. The aim is to compare corneal data before and after using the trial drug to determine which time point provides more accurate predictions of postoperative residual astigmatism. The anticipated results may serve as a reference for preoperative management to reduce corneal astigmatism prediction errors in cataract surgery patients with an OSDI score greater than 12. Additionally, this study aims to assess differences in corneal astigmatism prediction accuracy among patients with varying NITBUT levels.
control group: This part involves recruiting additional cataract patients who meet the same age and dry eye inclusion criteria as the original OOSSCC trial group to serve as a control group. It will compare the effects of using Systane COMPLETE on preoperative dry eye symptoms and postoperative dry eye symptoms. The anticipated results may provide recommendations for managing postoperative dry eye symptoms in cataract surgery patients with an OSDI score greater than 12.
Anticipated Results It is expected that for cataract patients with preoperative dry eye symptoms, particularly those with meibomian gland dysfunction, the study will improve the effectiveness of postoperative astigmatism correction while reducing discomfort caused by dry eye symptoms after surgery.
Hypothesis： Viscous artificial tears have been proven to alter preoperative corneal measurements in patients planning to undergo cataract surgery. This study aims to analyze the impact of lipid-containing nano-emulsion artificial tears on predicting residual astigmatism after cataract surgery.
mpact on Meibomian Gland Dysfunction and Dry Eye Symptoms:Meibomian gland dysfunction is the most common cause of evaporative dry eye. Cataract surgery alters the structure and function of the meibomian glands and reduces the thickness of the tear film lipid layer. However, no studies have yet reported the effectiveness of this type of artificial tear in alleviating dry eye symptoms induced by cataract surgery.
Objectives： Compare the corneal astigmatism data before and after the use of Systane COMPLETE to evaluate its impact on predicting changes in postoperative residual astigmatism.
Compare the effects of using or not using Systane COMPLETE on preoperative and postoperative Ocular Surface Disease Index (OSDI) scores and Non-Invasive Tear Break-Up Time (NITBUT).
Inclusion Criteria (experimental group) Cataract patients who participated in the "Optimizing the Ocular Surface with Systane COMPLETE in Patients with Dry Eye Planning for Cataract Surgery" trial (Research Ethics Committee Approval Number: 202311109MIPD) and did not withdraw from the trial midway.
Exclusion Criteria (experimental group) Patients unwilling to participate in this trial after surgery.
Inclusion Criteria (control group) Cataract patients aged between 20 and 85 years. Patients with normal cognitive function who are able to complete the dry eye questionnaire (with responses recorded by the research team) and are willing to undergo phacoemulsification and intraocular lens implantation under topical anesthesia.
Exclusion Criteria (control group) Unable to answer the questions in the dry eye survey. Ocular trauma or ocular surgery in the planned surgical eye, active ocular infection, and obvious abnormalities in ocular surface or eyelid margins other than MGD cause decreased visual acuity other than cataracts.
Dry eye signs: Corneal Fluorescein Staining CFS (+) to exclude any corneal abnormalities or epithelial defect.
Systemic drug use, including tetracycline derivatives, antihistamines, and isotretinoin.
Using dry eye medication at screening stage.
Sample Size This study plans to enroll a total of 140 participants, with 70 participants in the trial group and 70 in the control group.
- Conditions
- Ophthalmology
- Being tested
- Systane Complete
- Keywords
- Dry eye, cataract surgery, astigmatism, nano-emulsion, artificial tears
- Medical subject headings
- Dry Eye Syndromes, Astigmatism
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 tears that contain nano-emulsion of mineral oil and phospholipids.
| Study group | Role | What they receive |
|---|---|---|
| Systane COMPLETE | Experimental | The experimental group will receive Systane COMPLETE for one month before undergoing the cataract surgery and receive for one month since one week after the surgery. Receives: Drug: Systane Complete |
| Control group | No intervention | The control group will enrolled people who meet the same age and same dry eye syndrome criteria as the experimental group. The control group will not received any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of the keratometry data before and after using Systane COMPLETE
The change of the keratometry data is assessed for investigating ocular surface stability after using Systane COMPLETE. The keratometry data is measured using auto-refractor.
Measured: 1-2 months
Secondary outcomes (5)
The change of the refractive power before and after using Systane COMPLETE
The change of the refractive power is assessed for investigating ocular surface stability after using Systane COMPLETE. The refractive power measurement is completed using auto-refractor.
Measured: 1-2 months
The change of the biometry parameter before and after using Systane COMPLETE
The change of the biometry parameters ( ocular length, anterior chamber depth, lens thickness) are assessed for investigating ocular surface stability after using Systane COMPLETE. The biometry parameters is measured using Eyestar 900 (Haag-Streit Diagnostics, Switzerland).
Measured: 1-2 months
The change of corneal topology map before and after using Systane COMPLETE
The change of the corneal topology map is assessed for investigating ocular surface stability after using Systane COMPLETE. The corneal topology map is completed using Pentacam (OCULUS, German), and the corneal optical power is measured.
Measured: 1-2 months
The change of Ocular Surface Disease Index (OSDI) before and after using Systane COMPLETE
Whether Systane COMPLETE relieve dry eye symptoms subjetively is evaluated using the Ocular Surface Disease Index (OSDI) questionnaire. The OSDI questionnaire focuses on three aspects: self-reported eye discomfort, visual function impairment, and environmental triggers. The questionnaire contains 12 items, each rated on a scale from 0 to 4, with a total score ranging from 0 to 100. Higher scores indicate more severe dry eye symptoms. The OSDI questionnaire has high reliability and validity, aiding healthcare professionals in quickly assessing the severity of dry eye, making it suitable for clinical diagnosis and treatment evaluation.
Measured: 1-2 months
The change of Non-Invasive Tear Break-Up Time (NITBUT) before and after using Systane COMPLETE
Whether Systane COMPLETE relieve dry eye symptoms objectively is evaluated using Non-Invasive Tear Break-Up Time (NITBUT). NITBUT is measured using Keratography 5M (K5) to evaluate tear film stability, a key diagnostic indicator for dry eye.
Measured: 1-2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start25 Mar 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OphthalmologyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, double-arm study
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chiun Ho Hou, Ph.D, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886373
- Sponsor's protocol ID
- 202408096MIND
- Status last verified
- Apr 2026
- First submitted
- 23 Jan 2025
- Last updated
- 24 Apr 2026
- 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 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Ocular Surface With Systane COMPLETE Pre- and Post-operatively in Patients With Dry Eye Planning for Cataract Surgery: An Extension Study of Optimizing the Ocular Surface With Systane COMPLETE in Patients With Dry Eye Planning for Cataract Surgery
- ClinicalTrials.gov ID
- NCT06886373
- Acronym / sponsor ID
- 202408096MIND
- Conditions
- Ophthalmology
- Keywords
- Dry eye, cataract surgery, astigmatism, nano-emulsion, artificial tears
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Mar 2025 (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.
Compare the corneal astigmatism data before and after the use of Systane COMPLETE to evaluate its impact on predicting changes in postoperative residual astigmatism, as well as the effects of using or not using Systane COMPLETE on preoperative and postoperative Ocular Surface Disease Index (OSDI) scores and Non-Invasive Tear Break-Up Time (NITBUT).
Detailed description
STUDY OBJECTIVE： Compare the corneal astigmatism data before and after the use of Systane COMPLETE to evaluate its impact on predicting changes in postoperative residual astigmatism.
Compare the effects of using or not using Systane COMPLETE on preoperative and postoperative Ocular Surface Disease Index (OSDI) scores and Non-Invasive Tear Break-Up Time (NITBUT).
Background Cataract surgery is one of the most common and successful ophthalmic surgeries worldwide. However, cataract surgery can induce or exacerbate the severity of dry eye, leading to increased postoperative discomfort for patients. Additionally, undiagnosed preoperative dry eye can affect the accuracy of corneal astigmatism measurements, potentially impacting the astigmatic correction power of toric intraocular lenses used during surgery.
While general moisturizing artificial tears have been shown to significantly reduce postoperative ocular discomfort and tear film instability, it is notable that up to 50% of patients undergoing refractive or cataract surgery exhibit abnormalities in the tear film lipid layer, meeting the diagnostic criteria for meibomian gland dysfunction (MGD).
Given this, the application of lipid-containing nano-emulsion artificial tears before and after cataract surgery presents an unexplored opportunity to address two critical issues: reducing errors in corneal astigmatism measurements and alleviating dry eye symptoms induced by cataract surgery. This remains a topic worthy of investigation, as no existing studies have thoroughly examined these aspects.
Methods This study is an extension of the "Optimizing the Ocular Surface with Systane COMPLETE in Patients with Dry Eye Planning for Cataract Surgery" trial (Research Ethics Committee Approval Number: 202311109MIPD), hereinafter referred to as the OOSSCC trial.
The original OOSSCC trial began recruitment in May 2024 and focuses on analyzing patients with dry eye symptoms scheduled for cataract surgery. The trial evaluates the changes in corneal anterior surface astigmatism measurements, Ocular Surface Disease Index (OSDI) scores, and Non-Invasive Tear Break-Up Time (NITBUT) before and after one month of preoperative treatment with Systane COMPLETE.This trial will extend the study period to one month post-surgery and will be divided into two parts:
Experimental group:
This part extends the use of Systane COMPLETE for participants in the original OOSSCC trial to one month post-surgery. The aim is to compare corneal data before and after using the trial drug to determine which time point provides more accurate predictions of postoperative residual astigmatism. The anticipated results may serve as a reference for preoperative management to reduce corneal astigmatism prediction errors in cataract surgery patients with an OSDI score greater than 12. Additionally, this study aims to assess differences in corneal astigmatism prediction accuracy among patients with varying NITBUT levels.
control group: This part involves recruiting additional cataract patients who meet the same age and dry eye inclusion criteria as the original OOSSCC trial group to serve as a control group. It will compare the effects of using Systane COMPLETE on preoperative dry eye symptoms and postoperative dry eye symptoms. The anticipated results may provide recommendations for managing postoperative dry eye symptoms in cataract surgery patients with an OSDI score greater than 12.
Anticipated Results It is expected that for cataract patients with preoperative dry eye symptoms, particularly those with meibomian gland dysfunction, the study will improve the effectiveness of postoperative astigmatism correction while reducing discomfort caused by dry eye symptoms after surgery.
Hypothesis： Viscous artificial tears have been proven to alter preoperative corneal measurements in patients planning to undergo cataract surgery. This study aims to analyze the impact of lipid-containing nano-emulsion artificial tears on predicting residual astigmatism after cataract surgery.
mpact on Meibomian Gland Dysfunction and Dry Eye Symptoms:Meibomian gland dysfunction is the most common cause of evaporative dry eye. Cataract surgery alters the structure and function of the meibomian glands and reduces the thickness of the tear film lipid layer. However, no studies have yet reported the effectiveness of this type of artificial tear in alleviating dry eye symptoms induced by cataract surgery.
Objectives： Compare the corneal astigmatism data before and after the use of Systane COMPLETE to evaluate its impact on predicting changes in postoperative residual astigmatism.
Compare the effects of using or not using Systane COMPLETE on preoperative and postoperative Ocular Surface Disease Index (OSDI) scores and Non-Invasive Tear Break-Up Time (NITBUT).
Inclusion Criteria (experimental group) Cataract patients who participated in the "Optimizing the Ocular Surface with Systane COMPLETE in Patients with Dry Eye Planning for Cataract Surgery" trial (Research Ethics Committee Approval Number: 202311109MIPD) and did not withdraw from the trial midway.
Exclusion Criteria (experimental group) Patients unwilling to participate in this trial after surgery.
Inclusion Criteria (control group) Cataract patients aged between 20 and 85 years. Patients with normal cognitive function who are able to complete the dry eye questionnaire (with responses recorded by the research team) and are willing to undergo phacoemulsification and intraocular lens implantation under topical anesthesia.
Exclusion Criteria (control group) Unable to answer the questions in the dry eye survey. Ocular trauma or ocular surgery in the planned surgical eye, active ocular infection, and obvious abnormalities in ocular surface or eyelid margins other than MGD cause decreased visual acuity other than cataracts.
Dry eye signs: Corneal Fluorescein Staining CFS (+) to exclude any corneal abnormalities or epithelial defect.
Systemic drug use, including tetracycline derivatives, antihistamines, and isotretinoin.
Using dry eye medication at screening stage.
Sample Size This study plans to enroll a total of 140 participants, with 70 participants in the trial group and 70 in the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, double-arm study
| Arm | Type | Receives |
|---|---|---|
| Systane COMPLETE | Experimental | Drug: Systane CompleteThe experimental group will receive Systane COMPLETE for one month before undergoing the cataract surgery and receive for one month since one week after the surgery. |
| Control group | No intervention | –The control group will enrolled people who meet the same age and same dry eye syndrome criteria as the experimental group. The control group will not received any intervention. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cataract patients aged between 20 and 85 years.
- Patients with normal cognitive function who are able to complete the dry eye questionnaire (with - responses recorded by the research team) and are willing to undergo phacoemulsification and intraocular lens implantation under topical anesthesia.
Key exclusion criteria (5 listed)
- Unable to answer the questions in the dry eye survey.
- Ocular trauma or ocular surgery in the planned surgical eye, active ocular infection, and obvious abnormalities in ocular surface or eyelid margins other than MGD cause decreased visual acuity other than cataracts.
- Dry eye signs: Corneal Fluorescein Staining CFS (+) to exclude any corneal abnormalities or epithelial defect.
- Systemic drug use, including tetracycline derivatives, antihistamines, and isotretinoin.
- Using dry eye medication at screening stage.
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 tears that contain nano-emulsion of mineral oil and phospholipids. | Drug | Systane COMPLETE |
Primary outcome
The change of the keratometry data before and after using Systane COMPLETE
Time frame: 1-2 months
The change of the keratometry data is assessed for investigating ocular surface stability after using Systane COMPLETE. The keratometry data is measured using auto-refractor.
5 secondary outcomes
The change of the refractive power before and after using Systane COMPLETE
Time frame: 1-2 months
The change of the biometry parameter before and after using Systane COMPLETE
Time frame: 1-2 months
The change of corneal topology map before and after using Systane COMPLETE
Time frame: 1-2 months
The change of Ocular Surface Disease Index (OSDI) before and after using Systane COMPLETE
Time frame: 1-2 months
The change of Non-Invasive Tear Break-Up Time (NITBUT) before and after using Systane COMPLETE
Time frame: 1-2 months
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 24 Apr 2026.
- 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.
Chiun Ho Hou, Ph.D principal investigator
National Taiwan University Hospital
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 Complete in people with Ophthalmology, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 5 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 24 Apr 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 Taiwan. 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?
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 Chiun Ho Hou, Ph.D (+88623123456 ext. 262131, chiunhohou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of the keratometry data before and after using Systane COMPLETE (time frame: 1-2 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 24 Apr 2026.