Clinical Effects and Safety of 3% Diquafosol After Cataract Surgery

NCT02608489 | Completed Results DMC

• 1 other identifier: SCHUH 2013-12-012
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is determine whether 3% diquafosol and 0.1% sodium hyaluronate are effective and safe in the treatment of patients with dry eye after cataract surgery.

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (6)

• an Ocular Surface Disease Index (OSDI) Questionnaire That is Related to Dry Eye Severity.

  The OSDI questionnaire consists of 12 questions that evaluate subjective symptoms related to dry eye and vision The score ranges were between 0 and 100 scores and the higher scores represent a worse outcome.

  12 weeks

• Schirmer I Test Without Anesthesia That is Related to Dry Eye Severity.

  Schirmer paper strips were placed into the temporal one third of the lower conjunctival sac for 5 min and the wetness on the strips was measured.

  12 weeks

• Changes in HOAs After Blinking That is Related to Dry Eye Severity.

  Corneal HOAs and serial measurement of ocular total HOAs were evaluated using a KR-1W wavefront analyzer (Topcon Medical System, Inc., Tokyo, Japan). Serial measurement of total ocular HOAs was measured every second for 10 s after complete blinking in continuous measurement mode. The difference between the fifth and first HOA was used to evaluate the tear film instability.

  12 weeks

• Tear Break-up Time (TBUT) That is Related to Dry Eye Severity.

  TBUT was assessed by instillation of a drop of 2% sterile fluorescein into the conjunctival sac and recording the interval between the last complete blink and the first appearance of a dry spot or disruption of the tear film.

  12 weeks

• Corneal Fluorescein Staining That is Related to Dry Eye Severity.

  Ocular surface damage was assessed by the National Eye Institute (NEI) workshop grading system, and corneal fluorescein staining was evaluated. Instillation of fluorescein in both eyes. After 1 or 2 full blinks, the intensity of staining of both cornea was scored. According to the National Eye Institute (NEI) workshop grading system, the cornea was divided into five sections. The minimum staining score was 0 and the maximum staining score was 15 points (up to 3 points for each section). 0 : best score (no corneal damage) 15 : worst score (severe corneal damages)

  12 weeks

• Lissamine Green (LG) Conjunctival Staining That is Related to Dry Eye Severity

  Ocular surface damage was assessed by the National Eye Institute (NEI) workshop grading system, and conjunctival LG staining were evaluated. Instillation of 1% lissamine green in both eyes. After 1 or 2 full blinks, the intensity of staining of both medial and lateral bulbar conjunctiva was cored. According to the National Eye Institute (NEI) workshop grading system, the conjunctiva was divided into six sections. The minimum staining score was 0 and the maximum staining score was 18 points (up to 3 points for each section). 0 : best score (no conjunctival damage) 18 : worst score (severe conjunctival damages)

  12 weeks

Secondary Outcomes (2)

• Grades of Anterior Chamber Cells.

  12 weeks

• Number of Participants Who Stop Using the Eye Drops Due to Drug-related Discomfort

  12 weeks

Study Arms (2)

Diqufosol

ACTIVE COMPARATOR

3% Diquafosol Tetrasodium Ophthalmic Solution

Drug: Diquafosol (Diquas)

Hyaluronate

PLACEBO COMPARATOR

0.1% Sodium Hyaluronate Ophthalmic Solution

Drug: Sodium Hyaluronate (Hyalein)

Interventions

Diquafosol (Diquas) DRUG

Diquafosol group used diquafosol 6 times a day during study period.

Diqufosol

Sodium Hyaluronate (Hyalein) DRUG

Hyaluronate group used sodium hyaluronate 6 times a day during study period.

Hyaluronate

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bilateral or unilateral cataract undergoing phacoemulsification and intraocular lens (IOL) implantation at Soonchunhyang University Hospital between January 2014 and January 2015
• Patients with mild to moderate dry eye (level 1 or 2) based on the dry eye severity scale adopted by the Dry Eye Workshop (DEWS) report and who used only artificial tears occasionally

You may not qualify if:

• Presence of any complications after cataract surgery such as cystoid macular edema
• Patients using any topical eye drops on a regular basis
• Treatment history of dry eye beyond artificial tears
• Any ocular surgery within the prior 6 months
• Contact lens wear
• Serious ocular surface disease (e.g., Sjögren's syndrome, ocular pemphigoid, conjunctival scarring, chemical injury)
• Eyelid or lacrimal disease
• Use of concomitant medications that could cause dry eye and allergy to any of the study medications

Sponsors & Collaborators

• Soonchunhyang University Hospital: lead

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

diquafosol; Hyaluronic Acid

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Dr. JinKwon Chung
• Organization: Soonchunhyang University Hospital

schcornea@schmc.ac.kr

82-2-709-9354

Study Officials

• Jin Kwon Chung, MD

  Soonchunhyang University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Cornea & Refractive Surgery Service, Department of Ophthalmology

Study Record Dates

• First Submitted: November 14, 2015
• First Posted: November 18, 2015
• Study Start: January 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: October 17, 2016
• Results First Posted: October 17, 2016

Record last verified: 2016-08