Dry Eye Management With 3% Diquafosol Before and After Cataract Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Dry Eye
• Intervention / Treatment: Drug: Diquafosol

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Mun Wai Lee, MD; Phone Number: +60179210683; Email: munwai_lee@lec.com.my

Study Locations

• Malaysia
  • Perak
    • Ipoh, Perak, Malaysia, 30450
      • Recruiting
      • LEC Eye Centre
      • Contact: Mun Wai Lee, MD; Phone Number: +60179210683; Email: munwai_lee@lec.com.my

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

1. Eyes with pre-existing dry eye and visually significant cataract planned for phacoemulsification
2. Patients aged18years or older and in good general health
3. 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
4. Tear break-up time (TBUT) <10 seconds

Exclusion Criteria:

1. Eyes with complications after cataract surgery which require a prolonged course of topical medication
2. Eyes with history of contact lens wear in the previous 3 months
3. Eyes with history of regular use of topical eye drops(except artificial tears) in the previous 6 months
4. Treatment history of dry eye beyond artificial tears
5. Eyes with significant ocular surface disease (defined as CFS score of ≥3 on the Oxford scale)
6. Eyes with lacrimal or eyelid disease or ocular surface infections
7. Any ocular surgery within the prior 6 months
8. Using medications that could affect the dry eye condition (eg, antihistamines, antidepressants, decongestants, anticholinergic drugs or hormone treatment)
9. Allergies to Diquafosol

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	1 month preop, day of surgery, 1month and 3 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in uncorrected and best corrected visual acuity	Uncorrected and best corrected distance and near acuity measured with the Snellen chart	1 month preop, day of surgery, 1month and 3 months postoperatively

Collaborators and Investigators

• Sponsor: Mun Wai Lee
• Collaborators: Santen Oy
• Investigators: Principal Investigator: Mun Wai Lee, MD, LEC Eye Centre

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ANTICIPATED): December 30, 2021
• Study Completion (ANTICIPATED): December 30, 2021

Study Registration Dates

• First Submitted: May 5, 2021
• First Submitted That Met QC Criteria: July 6, 2021
• First Posted (ACTUAL): July 7, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2021
• Last Update Submitted That Met QC Criteria: July 6, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Cataract; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Capsule Opacification
• Other Study ID Numbers: LECDQCAT01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No