Trials Sponsors Conditions Drugs Pricing

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age20 Years - 90 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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

Sponsors & Collaborators

Soonchunhyang University Hospital
Otherlead

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

diquafosolHyaluronic Acid

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Results Point of Contact

Title: Dr. JinKwon Chung
Organization: Soonchunhyang University Hospital

Study Officials

Jin Kwon Chung, MD
Soonchunhyang University Hospital
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

86 participants (actual enrollment reported by the registry).

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 2014

Date type not reported

This date has not been verified as actual or estimated.

Clinical Effects and Safety of 3% Diquafosol After Cataract Surgery

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (2)

Study Arms (2)

Diqufosol

Hyaluronate

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (2)

Study Arms (2)

Diqufosol

Hyaluronate

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record