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

NCT ID: NCT04952987

Last Updated: 2021-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2021-12-30

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Diquafosol

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

Intervention Type: DRUG

Other Intervention Names

Diquas

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Santen Oy

INDUSTRY

Sponsor Role: collaborator

Mun Wai Lee

OTHER

Sponsor Role: lead

Responsible Party

Mun Wai Lee

Medical Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mun Wai Lee, MD

Role: PRINCIPAL_INVESTIGATOR

LEC Eye Centre

Locations

LEC Eye Centre

Ipoh, Perak, Malaysia

Site Status: RECRUITING

Countries

Malaysia

Central Contacts

Mun Wai Lee, MD

Role: CONTACT

munwai_lee@lec.com.my

+60179210683

Facility Contacts

Mun Wai Lee, MD

Role: primary

munwai_lee@lec.com.my

+60179210683

Other Identifiers

LECDQCAT01

Identifier Type: -

Identifier Source: org_study_id