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

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04952987
• Other study ID #: LECDQCAT01
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: July 2021
• Source: LEC Eye Centre
• Contact: Mun Wai Lee, MD
• Phone: +60179210683
• Email: munwai_lee[@]lec.com.my
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract
• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Diquafosol
Diquafosol (Diquas) is a P2Y2 receptor agonist which improves mucin and tear secretion

Locations

Country	Name	City	State
Malaysia	LEC Eye Centre	Ipoh	Perak

Sponsors (2)

Lead Sponsor	Collaborator
Mun Wai Lee	Santen Oy

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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