Dry EyeNCT04952987
Dry Eye Management With 3% Diquafosol Before and After Cataract Surgery
An observational study of Dry Eye, run by Mun Wai Lee at 1 site in Malaysia.
Trial summary
The objective of this study is to evaluate the efficacy of Diquafosol 3% in the management of dry eyes before and after cataract surgery. Patients with pre-existing dry eyes and planned for cataract surgery will be started on Diquafosol eyedrops prior to surgery and treatment will be continued after cataract surgery. 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?
- Diquafosol
- How many people
- 50 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jan 2021to 30 Dec 2021
- Phase
- Observational
- 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
Study population: Eligible subjects will be selected from a population of patients who have mild to moderate dry eye as well as significant cataract listed for phacoemulsification cataract surgery.
Who may be able to join
- Eyes with pre-existing dry eye and visually significant cataract planned for phacoemulsification
- Patients aged18years or older and in good general health
- Mild to moderate dry eye; non-visually significant ocular surface disease (NVS-OSD) defined as Corneal Fluorescein Staining (CFS) score of <3 on the Oxford scale
- Tear break-up time (TBUT) <10 seconds
Who cannot join
- Eyes with complications after cataract surgery which require a prolonged course of topical medication
- Eyes with history of contact lens wear in the previous 3 months
- Eyes with history of regular use of topical eye drops(except artificial tears) in the previous 6 months
- Treatment history of dry eye beyond artificial tears
- Eyes with significant ocular surface disease (defined as CFS score of ≥3 on the Oxford scale)
- Eyes with lacrimal or eyelid disease or ocular surface infections
Show all 9Show fewer
- Any ocular surgery within the prior 6 months
- Using medications that could affect the dry eye condition (eg, antihistamines, antidepressants, decongestants, anticholinergic drugs or hormone treatment)
- Allergies to Diquafosol
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
LEC Eye Centre
Ipoh, Perak, 30450
Mun Wai Lee, MD, +60179210683, munwai_lee@lec.com.my
About this study
The objective of this study is to evaluate the efficacy of Diquafosol 3% in the management of dry eyes before and after cataract surgery. Patients with pre-existing dry eyes and planned for cataract surgery will be started on Diquafosol eyedrops prior to surgery and treatment will be continued after cataract surgery. Eligible patients will undergo evaluation of dry eye at baseline and subsequently started on treatment with Diquafosol for the duration of 4 weeks before surgery. Further evaluations will be conducted on the day of surgery and at designated time points during and up to 12 weeks after surgery.
Read the detailed description
Title: Dry Eye Management with 3% Diquafosol Before and After Cataract Surgery
Setting: LEC Eye Centre, Ipoh, Malaysia
Background: Dry eye disease and cataract are two conditions which have been known to increase in incidence with age. Dry eye disease can also be further exacerbated by cataract surgery. Diquafosol (Diquas) is a P2Y2 receptor agonist which improves mucin and tear secretion and is a 'first in class' therapeutic option which has been shown repeatedly to be efficacious in dry eye management.
Objective: To evaluate the efficacy of Diquafosol for dry eye management in patients with pre-existing dry eye disease before and after cataract surgery
Design: Observational case series in a private ophthalmic health facility
Study Plan: Eligible patients will have treatment with Diquas for 4 weeks prior to undergoing cataract surgery. Preoperative clinical evaluation will include documentation of severity of signs and symptoms of dry eye and this will be carried out at baseline, immediately before surgery and subsequently at Week 4 and Week 12.
- Conditions
- Dry Eye
- Being tested
- Diquafosol
- 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.
DiquafosolDrug
Also called Diquas
Diquafosol (Diquas) is a P2Y2 receptor agonist which improves mucin and tear secretion
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Standard Patient Evaluation of Eye Dryness (SPEED) II questionnaire score
A validated dry eye questionnaire designed to evaluate eye dryness prior to cataract surgery
Measured: 1 month preop, day of surgery, 1month and 3 months postoperatively
Change in Tear Break Up Time
Measure of time taken for ocular tear film to disperse
Measured: 1 month preop, day of surgery, 1month and 3 months postoperatively
Change in Conjunctival and corneal fluorescein staining score
Fluorescein scoring system based on NEI Grading
Measured: 1 month preop, day of surgery, 1month and 3 months postoperatively
Secondary outcomes (1)
Change in uncorrected and best corrected visual acuity
Uncorrected and best corrected distance and near acuity measured with the Snellen chart
Measured: 1 month preop, day of surgery, 1month and 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start1 Jan 2021
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mun Wai Lee
- Sponsor type
- University, hospital or other
- Collaborators
- Santen Oy
- Responsible party
- Sponsor-investigator, Mun Wai Lee, LEC Eye Centre
- Investigators
- Mun Wai Lee, MD, Principal investigator, LEC Eye Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952987
- Sponsor's protocol ID
- LECDQCAT01
- Status last verified
- Jul 2021
- First submitted
- 5 May 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dry Eye Management With 3% Diquafosol Before and After Cataract Surgery
- ClinicalTrials.gov ID
- NCT04952987
- Acronym / sponsor ID
- LECDQCAT01
- Conditions
- Dry Eye
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mun Wai LeeUniversity, hospital or other
- Collaborators
- Santen Oy
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 7 Jul 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 objective of this study is to evaluate the efficacy of Diquafosol 3% in the management of dry eyes before and after cataract surgery. Patients with pre-existing dry eyes and planned for cataract surgery will be started on Diquafosol eyedrops prior to surgery and treatment will be continued after cataract surgery. Eligible patients will undergo evaluation of dry eye at baseline and subsequently started on treatment with Diquafosol for the duration of 4 weeks before surgery. Further evaluations will be conducted on the day of surgery and at designated time points during and up to 12 weeks after surgery.
Detailed description
Title: Dry Eye Management with 3% Diquafosol Before and After Cataract Surgery
Setting: LEC Eye Centre, Ipoh, Malaysia
Background: Dry eye disease and cataract are two conditions which have been known to increase in incidence with age. Dry eye disease can also be further exacerbated by cataract surgery. Diquafosol (Diquas) is a P2Y2 receptor agonist which improves mucin and tear secretion and is a 'first in class' therapeutic option which has been shown repeatedly to be efficacious in dry eye management.
Objective: To evaluate the efficacy of Diquafosol for dry eye management in patients with pre-existing dry eye disease before and after cataract surgery
Design: Observational case series in a private ophthalmic health facility
Study Plan: Eligible patients will have treatment with Diquas for 4 weeks prior to undergoing cataract surgery. Preoperative clinical evaluation will include documentation of severity of signs and symptoms of dry eye and this will be carried out at baseline, immediately before surgery and subsequently at Week 4 and Week 12.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible subjects will be selected from a population of patients who have mild to moderate dry eye as well as significant cataract listed for phacoemulsification cataract surgery.
Key inclusion criteria (4 listed)
- Eyes with pre-existing dry eye and visually significant cataract planned for phacoemulsification
- Patients aged18years or older and in good general health
- Mild to moderate dry eye; non-visually significant ocular surface disease (NVS-OSD) defined as Corneal Fluorescein Staining (CFS) score of <3 on the Oxford scale
- Tear break-up time (TBUT) <10 seconds
Key exclusion criteria (9 listed)
- Eyes with complications after cataract surgery which require a prolonged course of topical medication
- Eyes with history of contact lens wear in the previous 3 months
- Eyes with history of regular use of topical eye drops(except artificial tears) in the previous 6 months
- Treatment history of dry eye beyond artificial tears
- Eyes with significant ocular surface disease (defined as CFS score of ≥3 on the Oxford scale)
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 |
|---|---|---|
| DiquafosolAlso: DiquasDiquafosol (Diquas) is a P2Y2 receptor agonist which improves mucin and tear secretion | Drug | – |
Primary outcome
Change in Standard Patient Evaluation of Eye Dryness (SPEED) II questionnaire score
Time frame: 1 month preop, day of surgery, 1month and 3 months postoperatively
A validated dry eye questionnaire designed to evaluate eye dryness prior to cataract surgery
Change in Tear Break Up Time
Time frame: 1 month preop, day of surgery, 1month and 3 months postoperatively
Measure of time taken for ocular tear film to disperse
Change in Conjunctival and corneal fluorescein staining score
Time frame: 1 month preop, day of surgery, 1month and 3 months postoperatively
Fluorescein scoring system based on NEI Grading
1 secondary outcome
Change in uncorrected and best corrected visual acuity
Time frame: 1 month preop, day of surgery, 1month and 3 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
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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.
Mun Wai Lee, MD principal investigator
LEC Eye Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye, run by Mun Wai Lee at 1 site in Malaysia.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 7 Jul 2021. 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 Malaysia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mun Wai Lee, MD (+60179210683, munwai_lee@lec.com.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Standard Patient Evaluation of Eye Dryness (SPEED) II questionnaire score (time frame: 1 month preop, day of surgery, 1month and 3 months postoperatively). The study lists 3 primary outcomes in all. 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 7 Jul 2021.