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

NCT04952987 | Unknown

• 1 other identifier: LECDQCAT01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Change in uncorrected and best corrected visual acuity

  1 month preop, day of surgery, 1month and 3 months postoperatively

Interventions

Diquafosol DRUG

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

Also known as: Diquas

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Mun Wai Lee: lead
• Santen Oy: collaborator

Study Sites (1)

LEC Eye Centre

Ipoh, Perak, 30450, Malaysia

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

diquafosol

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Mun Wai Lee, MD

  LEC Eye Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mun Wai Lee, MD

CONTACT

+60179210683; munwai_lee@lec.com.my

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: July 7, 2021
• Study Start: January 1, 2021
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: July 7, 2021

Record last verified: 2021-07

Locations

MY (1)