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Clinical Effects and Safety of 3% Diquafosol After Cataract Surgery

Primary Purpose

Dry Eye Syndromes

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Diquafosol (Diquas)
Sodium Hyaluronate (Hyalein)
Sponsored by
Soonchunhyang University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Diqufosol

    Hyaluronate

    Arm Description

    3% Diquafosol Tetrasodium Ophthalmic Solution

    0.1% Sodium Hyaluronate Ophthalmic Solution

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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)
    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)

    Secondary Outcome Measures

    Grades of Anterior Chamber Cells.
    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
    Number of Participants Who Stop Using the Eye Drops Due to Drug-related Discomfort
    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.

    Full Information

    First Posted
    November 14, 2015
    Last Updated
    August 22, 2016
    Sponsor
    Soonchunhyang University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02608489
    Brief Title
    Clinical Effects and Safety of 3% Diquafosol After Cataract Surgery
    Official Title
    Clinical Effects and Safety of 3% Diquafosol Ophthalmic Solution for Patients With Dry Eye After Cataract Surgery: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    January 2015 (Actual)
    Study Completion Date
    January 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Soonchunhyang University Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    Study group and protocol: This was a prospective open-label randomized study. All patients were given a full explanation of the study, and written informed consent was obtained from all participants. The study protocol adhered to the tenets of the Declaration of Helsinki. The Institutional Review Board and Ethics Committee, Soonchunhyang University Seoul Hospital, approved this study (SCHUH 2013-12-012). Patients were randomly allocated into the diquafosol group (D group) or the hyaluronate group (H group) using a simple unrestricted randomization method by the controller. The D group used 3% diquafosol tetrasodium ophthalmic solution (Diquas®; Santen Pharmaceutical Co., Ltd., Osaka, Japan) six times a day and the H group used 0.1% sodium hyaluronate ophthalmic solution (Hyalein®; Santen Pharmaceutical Co., Ltd., Osaka, Japan) six times a day. Both groups instilled each eye drop from postoperative day 1 to postoperative week 12. Participants: Consecutive patients aged 20-90 years with bilateral or unilateral cataract undergoing uncomplicated phacoemulsification and intraocular lens (IOL) implantation at Soonchunhyang University Hospital between January 2014 and January 2015 were enrolled. The inclusion criteria were 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 occasionally1, and patients without or with mild blepharitis.18 The exclusion criteria were 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), lacrimal or eyelid disease (e.g., moderate to severe blepharitis18), use of concomitant medications that could cause dry eye (e.g., antihistamines, antidepressants, decongestants, anticholinergic drugs), and allergy to any of the study medications. Objective and subjective clinical assessments of dry eye: All patients underwent ophthalmic examinations preoperatively and postoperatively in the order of following : uncorrected distant visual acuity (UDVA) test, an ocular surface disease index (OSDI) questionnaire, Schirmer I test without anesthesia, changes in HOAs after blinking, tear break-up time (TBUT), corneal fluorescein staining, and lissamine green (LG) conjunctival staining. Eyelid and anterior chamber cells were evaluated by slit-lamp biomicroscopy to assess the presence of blepharitis/meibomian gland plugging and intraocular inflammation. Routine postoperative examinations were scheduled for 1 week, 4 weeks, and 12 weeks after surgery. Efficacy and safety evaluation: To evaluate the efficacy of the two different eye drops, we compared each measurement between the two groups throughout the study period, and at each follow-up, and also compared the patterns of changes in each group to identify which group recovered earlier. we evaluated the safety of the two eye drops, including anterior chamber inflammation and discontinuation of the eye drops due to drug-related discomfort. 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. Surgical procedure: A 2.8 mm clear corneal incision was made at the location of the steep corneal astigmatism axis. A standard phacoemulsification technique was used with topical anesthesia with 2% lidocaine. A foldable IOL was implanted into the capsular bag. There was no suture at the corneal incision site. Patients received moxifloxacin (Vigamox; Alcon, Fort Worth, TX), which is a preservative-free formulation, and rimexolone (Vexol; Alcon), which contains 0.01% BAK, four times a day after surgery for 4 weeks. Statistical analysis: For statistical analysis, UDVA was converted from Snellen into logMAR values. Baseline data were compared between the groups using the Mann-Whitney U-test, Fisher's exact test, and the linear mixed model after adjusting for inter-eye correlations, age, and sex. In addition, another mixed model was used to compare measurement data between the two groups by considering the correlation between both eyes of each patient at each follow-up. To obtain an overall comparison between treatment responses throughout the study period considering the two levels of correlation in subjects and follow-up, a bivariate generalized linear mixed (GLM) model with asymmetric random effects was used. In the last step, a bivariate GLM model was also used to identify the patterns of changes in measured data throughout the study period. The intergroup differences in adverse events were analyzed using Fisher's exact test. SPSS software (version 21, SPSS, Inc., Chicago, IL) was used for all statistical analyses, and P < .05 was taken to indicate statistical significance.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dry Eye Syndromes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    86 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Diqufosol
    Arm Type
    Active Comparator
    Arm Description
    3% Diquafosol Tetrasodium Ophthalmic Solution
    Arm Title
    Hyaluronate
    Arm Type
    Placebo Comparator
    Arm Description
    0.1% Sodium Hyaluronate Ophthalmic Solution
    Intervention Type
    Drug
    Intervention Name(s)
    Diquafosol (Diquas)
    Intervention Description
    Diquafosol group used diquafosol 6 times a day during study period.
    Intervention Type
    Drug
    Intervention Name(s)
    Sodium Hyaluronate (Hyalein)
    Intervention Description
    Hyaluronate group used sodium hyaluronate 6 times a day during study period.
    Primary Outcome Measure Information:
    Title
    an Ocular Surface Disease Index (OSDI) Questionnaire That is Related to Dry Eye Severity.
    Description
    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.
    Time Frame
    12 weeks
    Title
    Schirmer I Test Without Anesthesia That is Related to Dry Eye Severity.
    Description
    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.
    Time Frame
    12 weeks
    Title
    Changes in HOAs After Blinking That is Related to Dry Eye Severity.
    Description
    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.
    Time Frame
    12 weeks
    Title
    Tear Break-up Time (TBUT) That is Related to Dry Eye Severity.
    Description
    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.
    Time Frame
    12 weeks
    Title
    Corneal Fluorescein Staining That is Related to Dry Eye Severity.
    Description
    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)
    Time Frame
    12 weeks
    Title
    Lissamine Green (LG) Conjunctival Staining That is Related to Dry Eye Severity
    Description
    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)
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Grades of Anterior Chamber Cells.
    Description
    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
    Time Frame
    12 weeks
    Title
    Number of Participants Who Stop Using the Eye Drops Due to Drug-related Discomfort
    Description
    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.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jin Kwon Chung, MD
    Organizational Affiliation
    Soonchunhyang University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Effects and Safety of 3% Diquafosol After Cataract Surgery

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