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AzTrials

Dry Eye DiseasePhase 4NCT06221345

Hyaluronic Acid-containing Artificial Tears in Post-cataract Surgery Dry Eye Disease

A Phase 4 study testing Systane HYDRATION® Preservative-Free Lubricant Eye Drops and Optive Fusion® Lubricant Eye Drops (Unit Dose) in people with Dry Eye Disease and Cataract, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To compare the effects of hydroxypropyl guar (HPG)/hyaluronic acid (HA)- and carboxymethylcellulose (CMC)/HA-based lubricant eye drops on subjective and objective outcomes in dry eye disease (DED) patients after cataract surgery. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Dry Eye Disease, Cataract
What is being tested?
Systane HYDRATION® Preservative-Free Lubricant Eye Drops and Optive Fusion® Lubricant Eye Drops (Unit Dose)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteTaiwan
Study dates
7 Dec 2021to 5 Jul 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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients of any race, 20 years or older who are scheduled for unilateral cataract surgery.
  • DED patients whose symptoms and signs are aggravated at baseline assessment after cataract surgery will be eligible for this study. Postoperative dry eye diagnosis criteria at baseline assessment:
  • OSDI score >14.8* (*Eligible subject mandatory required);
  • positive CFS* (*Eligible subject mandatory required);
  • Schirmer's test score ≤10 mm in 5 minutes (min) (without anesthesia);
  • TBUT ≤5 seconds (sec)

Who cannot join

  • Patients with allergy to any of the study medications, conjunctival allergy or infectious disease, history of ocular chemical or thermal burn, Stevens-Johnson syndrome or ocular pemphigoid, glaucoma or ocular hypertension, eyelid or lacrimal disease, any ocular operation within 3 months, graft-versus-host disease (GVHD), non-dry-eye ocular inflammation, trauma, or presence of uncontrolled systemic disease.
  • Before enrollment, corneal contact lens wear, history of severe systemic disease, or other conditions in the Investigator's opinion precluded enrollment.
  • Patients will be withdrawn from the study if they experience complications during surgery, or post-surgical ocular hypertension, endophthalmitis, or infectious keratitis.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Keelung Chang Gung Memorial Hospital

    Keelung

Other trials in Taiwan

About this study

Official title: Comparison of Different Hyaluronic Acid-containing Artificial Tears on the Ocular Surface Disease in Patients With Post-cataract Surgery Dry Eye

To compare the effects of hydroxypropyl guar (HPG)/hyaluronic acid (HA)- and carboxymethylcellulose (CMC)/HA-based lubricant eye drops on subjective and objective outcomes in dry eye disease (DED) patients after cataract surgery.

Read the detailed description

This is a prospective, open-label, assessor-masked, interventional, randomized controlled study. A total of 70 post-cataract surgery dry-eye subjects are planned to be enrolled after eligibility confirmation at Week 1 post-operative (post-op). The subjects will then be randomized in a 1:1 ratio to either HPG/HA (Systane HYDRATION® ) or CMC/HA (Optive Fusion®) group.

From Week 1 to 3 (1st to 4th week post-op), the HPG/HA group will receive Systane HYDRATION® Preservative-Free Lubricant Eye Drops whereas the CMC/HA group will receive Optive Fusion® Lubricant Eye Drops (Unit Dose). Both groups will receive 1-2 drops of artificial tears 4 times daily for 3 weeks.

There are three visits scheduled in this study, i.e., screening, Week 1, and Week 3. The subjects will return to the study sites during these visits for efficacy and safety assessments.

Being tested
Systane HYDRATION® Preservative-Free Lubricant Eye Drops, Optive Fusion® Lubricant Eye Drops (Unit Dose)
Keywords
Hyaluronic Acid, Hydroxypropyl guar, Carboxymethylcellulose
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® Preservative-Free Lubricant Eye DropsDrug

    The HPG/HA group will receive Systane HYDRATION® Preservative-Free Lubricant Eye Drops and standard of care, i.e., prednisolone acetate (Pred forte®) and levofloxacin (Cravit®), at the dosage of 1-2 drops 4 times daily for 3 weeks from Weeks 1 to 4 post-op

  • Optive Fusion® Lubricant Eye Drops (Unit Dose)Drug

    The CMC/HA group will receive Optive Fusion® Lubricant Eye Drops (Unit Dose) and standard of care, i.e., prednisolone acetate (Pred forte®) and levofloxacin (Cravit®), at the dosage of 1-2 drops 4 times daily for 3 weeks from Weeks 1 to 4 post-op

Study groups in NCT06221345
Study groupRoleWhat they receive
HPG/HA groupExperimentalSystane HYDRATION®
Receives: Drug: Systane HYDRATION® Preservative-Free Lubricant Eye Drops
CMC/HA groupActive comparatorOptive Fusion®
Receives: Drug: Optive Fusion® Lubricant Eye Drops (Unit Dose)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Corneal fluorescein staining (CFS) score

    The CFS will be evaluated by external eye photography using the National Eye Institute (NEI) staining grid in which a score of 0 (normal) to 3 (severe) will be assigned to each of the 5 corneal regions (nasal, central, temporal, superior, and inferior). The CFS score will range between 0 and 15, and the maximum score of 15 indicates severe epitheliopathy.

    Measured: Change from baseline to Weeks 1 and 3

Secondary outcomes (5)

  1. Ocular Surface Disease Index (OSDI)

    The OSDI score is a 12-item patient-reported outcomes questionnaire with an overall score ranging from 0 to 100 to assess ocular surface symptoms, and the subjects can be categorized as having a normal (0-12), mild (13-22), moderate (23-32), or severe (33-100) ocular surface disease based on their OSDI score.

    Measured: Change from baseline to Weeks 1 and 3

  2. Schirmer's test (without anesthesia)

    Schirmer's test is a quantitative test to measure maximal tear secretion capacity. A filter paper will be placed in the lower fornix for 5 min and the and the length of wetted paper is measured.While a Schirmer's test score of greater than 10 mm/5 min is classified as normal, test score of less than 5 mm/5 min indicates tear deficiency.

    Measured: Change from baseline to Weeks 1 and 3

  3. Tear break-up time (TBUT)

    TBUT is used to assess the tear film stability by recording the interval between the last blink and the first appearance of a dry spot. TBUT less than 10 sec suggests an abnormal tear film. While TBUT between 5 to 10 sec is considered marginal, TBUT less than 5 sec indicates dry eye.

    Measured: Change from baseline to Weeks 1 and 3

  4. Central corneal sensitivity

    Central corneal sensitivity will be measured using a Cochet-Bonnet esthesiometer. The 6.0-cm long nylon monofilament was held perpendicular to the subject's cornea and reduced at an interval of 0.5 cm until the subject reported that he/she was aware of the discomfort. The longer the length of the monofilament used, the greater sensitivity the subjects have.

    Measured: Change from baseline to Weeks 1 and 3

  5. Slit-lamp examination

    The slit-lamp examinations allow the physicians to identify dry eye signs on the subject. The eye structures (eyelids, cornea, and conjunctiva) of the subjects will be graded based on the United States Food and Drug Administration (FDA) grading system. While Grade 0 represents normal, the highest grade (i.e., Grade 4) indicates the subject may have very severe changes that require intervention, often medical.

    Measured: Change from baseline to Weeks 1 and 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2024
  2. Study start7 Dec 2021
  3. Primary completion5 Jul 2023
  4. Study completion5 Jul 2023

Resources

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06221345
Sponsor's protocol ID
60298913
Status last verified
Jan 2024
First submitted
2 Jan 2024
Last updated
24 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Sun CC, Chan YH, Huang PW, Chen NN. Evaluation of Two Artificial Tears Containing Hyaluronic Acid for Post Cataract Surgery Dry Eye Disease: A Randomized Controlled Trial. Ophthalmol Ther. 2024 Oct;13(10):2615-2627. doi: 10.1007/s40123-024-01015-9. Epub 2024 Aug 10.

    PubMed 39127813

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Systane HYDRATION® Preservative-Free Lubricant Eye Drops and Optive Fusion® Lubricant Eye Drops (Unit Dose) in people with Dry Eye Disease and Cataract, run by Chang Gung Memorial 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 6 inclusion and 3 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 24 Jan 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 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?

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 fluorescein staining (CFS) score (time frame: Change from baseline to Weeks 1 and 3). 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 NCT06221345, 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 24 Jan 2024.

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