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Clinical Effects and Safety of 3% Diquafosol After Cataract Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02608489
Recruitment Status : Completed
First Posted : November 18, 2015
Results First Posted : October 17, 2016
Last Update Posted : October 17, 2016
Sponsor:
Information provided by (Responsible Party):
Jin Kwon Chung, Soonchunhyang University Hospital

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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Drug: Diquafosol (Diquas) Drug: Sodium Hyaluronate (Hyalein) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Effects and Safety of 3% Diquafosol Ophthalmic Solution for Patients With Dry Eye After Cataract Surgery: A Randomized Controlled Trial
Study Start Date : January 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Active Comparator: Diqufosol
3% Diquafosol Tetrasodium Ophthalmic Solution
Drug: Diquafosol (Diquas)
Diquafosol group used diquafosol 6 times a day during study period.

Placebo Comparator: Hyaluronate
0.1% Sodium Hyaluronate Ophthalmic Solution
Drug: Sodium Hyaluronate (Hyalein)
Hyaluronate group used sodium hyaluronate 6 times a day during study period.




Primary Outcome Measures :
  1. an Ocular Surface Disease Index (OSDI) Questionnaire That is Related to Dry Eye Severity. [ Time Frame: 12 weeks ]
    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.

  2. Schirmer I Test Without Anesthesia That is Related to Dry Eye Severity. [ Time Frame: 12 weeks ]
    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.

  3. Changes in HOAs After Blinking That is Related to Dry Eye Severity. [ Time Frame: 12 weeks ]
    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.

  4. Tear Break-up Time (TBUT) That is Related to Dry Eye Severity. [ Time Frame: 12 weeks ]
    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.

  5. Corneal Fluorescein Staining That is Related to Dry Eye Severity. [ Time Frame: 12 weeks ]

    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)


  6. Lissamine Green (LG) Conjunctival Staining That is Related to Dry Eye Severity [ Time Frame: 12 weeks ]

    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)



Secondary Outcome Measures :
  1. Grades of Anterior Chamber Cells. [ Time Frame: 12 weeks ]

    Anterior chamber inflammation was examined with a slit-lamp clinically, and divided into six grades using the Standardization of Uveitis Nomenclature (SUN) working group grading scheme.

    grade 0 : <1 cell in field, grade 0.5 : 1-5 cells in field, grade 1 : 6-15 cells in field, grade 2 : 16-25 cells in field grade 3 : 26-50 cells in field, grade 4 : >50 cells in field Field size is a 1 mm X 1 mm slit beam


  2. Number of Participants Who Stop Using the Eye Drops Due to Drug-related Discomfort [ Time Frame: 12 weeks ]
    Drug-related discomfort is defined as having started after eye drop instillation and lasting several minutes, occurring every time during instillation at any time up to 12 weeks into the follow-up period. Patients that had any adverse events or wanted to stop using the eye drops were excluded from the study, but these patients were included in the safety evaluation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608489


Sponsors and Collaborators
Soonchunhyang University Hospital
Investigators
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Principal Investigator: Jin Kwon Chung, MD Soonchunhyang University Hospital
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Responsible Party: Jin Kwon Chung, Assistant Professor, Cornea & Refractive Surgery Service, Department of Ophthalmology, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier: NCT02608489    
Other Study ID Numbers: SCHUH 2013-12-012
First Posted: November 18, 2015    Key Record Dates
Results First Posted: October 17, 2016
Last Update Posted: October 17, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Cataract
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Capsule Opacification
Lens Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents