Comparison of the efficacy and extend of ocular surface toxicity between a preservative- free methylprednisolone topical preparation and preserved prednisolone eye drop in the treatment of acute anterior uveitis
Objective: To evaluate the anti-inflammatory efficacy and extend of ocular surface toxicity of nonpreserved methylprednisolone 1% compared with preserved prednisolone acetate suspension 1% eyedrops for management of acute anterior uveitis Design: Prospective, randomized, investigator-masked, comparative clinical trial Setting and conduct: Eyes with non-infectious acute anterior uveitis would be assigned to receive either of study medications eye drops randomly ( preservative free methylprednisolone 1% in case group and preserved prednisolon acetate 1% in control group). During the follow-up, anterior chamber cell (based on SUN group classification) and flare (using laser flare photometer- Kowa FM-600) would be evaluated for comparison of the anti-inflammatory effect. Ocular surface toxicity would be assessed by objective ratings of corneal irritation (corneal fluorescein staining scores) and tear film stability indices (tear break-up time, Schirmer I test), as well as questioner-based grading of ocular discomfort parameters. All the measurement would be repeated on each follow-up visit (first and second weeks post treatment) Participants: 60 eligible eyes (60 consecutive patients) with unilateral non-infectious acute anterior uveitis with at least 2+ anterior chamber cells based on SUN group classification Intervention: Receiving either hourly nonpreserved methylprednisolone 1% or preserved prednisolone 1% (Pred Forte 1%, Allergan, Inc) eye drops followed by a 2-week tapering regimen Main outcome: The main outcome measure would be the grade of anterior chamber cell (based on SUN group classification) on day 14.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012101511125N1
Registration date:2013-03-09, 1391/12/19
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-03-09, 1391/12/19
Registrant information
Name
Alireza Hedayatfar
Name of organization / entity
Noor Ophthalmic Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 8865 1515
Email address
ahedayatfar@norc.ac.ir
Recruitment status
Recruitment complete
Funding source
Funded by Vice chancellor of Noor Research Eye Center (NORC)
Expected recruitment start date
2013-04-04, 1392/01/15
Expected recruitment end date
2013-06-22, 1392/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy and extend of ocular surface toxicity between a preservative- free methylprednisolone topical preparation and preserved prednisolone eye drop in the treatment of acute anterior uveitis
Public title
Comparison of two type of steroidal eyedrops in treatment of uveitis
Purpose
Treatment
Inclusion/Exclusion criteria
Eligibility criteria were:
1- age 16 years or older; 2- attack duration less than one week period; 3- no high intraocular pressure at presentation; 4-negative clues for infectious (e.g. corneal scars, iris atrophy) or granulomatous inflammation (e.g. granulomatous keratic precipitate or iris nodule).
The following exclusion criteria would be used:
1-eyes with hypopyon or florid fibrin formation; 2-prior unsuccessful topical treatment; 3- known cases of Behcet disease; 4-any slit-lamp evidence of significant blepharitis or meibomian gland dysfunction; 5-recent use of contact lenses.
Age
From 16 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
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Secondary trial Id
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Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of NOOR OPHTHALMIC RESEARCH CENTER
Street address
NOOR EYE HOSPITAL (7TH FLOOR), 96 ESFANDIAR ST, VALI-E-ASR STt,
City
TEHRAN
Postal code
1968653111
Approval date
2013-01-15, 1391/10/26
Ethics committee reference number
م/841
Health conditions studied
1
Description of health condition studied
acute anterior uveitis
ICD-10 code
H20.0
ICD-10 code description
Acute and subacute iridocyclitis
Primary outcomes
1
Description
anterior chamber inflammation
Timepoint
1 week and 2 week after treatment
Method of measurement
Anterior chamber flare would be assessed using the laser flare photometer .anterior chamber cell would be assessed using slit lamp by standard grading system (1-4, SUN)
Secondary outcomes
1
Description
Corneal toxicity
Timepoint
1 week and 2 week after treatment
Method of measurement
Schirmer I test, tear break-up time, and corneal fluorescein staining scores
2
Description
Subjective discomfort
Timepoint
1 week and 2 week after treatment
Method of measurement
Questionary
Intervention groups
1
Description
In case group: self- instillation of nonpreserved methylprednisolone sodium succinate 1 % every hour one eye drop during daytime for the first week and then upon clinical response
Category
Treatment - Drugs
2
Description
In control group: self- instillation of preserved prednisolone acetate 1% (Pred Forte 1%, Allergan, Inc) every hour one eye drop during daytime for the first week then upon clinical response
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
NOOR EYE HOSPITAL
Full name of responsible person
ALIREZA HEDAYATFAR
Street address
NOOR EYE HOSPITAL, 96 ESFANDIAR ST, VALI-E-ASR ST
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Noor Ophthalmic research Center (NORC)
Full name of responsible person
Dr. FARHAD REZVAN
Street address
NOOR EYE HOSPITAL (7TH FLOOR), 96 ESFANDIAR ST, VALI-E-ASR ST
City
TEHRAN
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Noor Ophthalmic research Center (NORC)
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
NOOR EYE HOSPITAL
Full name of responsible person
Alireza Hedayatfar
Position
Ocular inflammation and Uveitis fellowship
Other areas of specialty/work
Street address
NOOR EYE HOSPITAL, 96 ESFANDIAR ST, VALI-E-ASR ST
City
TEHRAN
Postal code
Phone
+98 21 82400
Fax
Email
ahedayatfar@norc.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
NOOR EYE HOSPITAL
Full name of responsible person
ALIREZA HEDAYATFAR
Position
Ocular Inflammation and Uveitis fellowship
Other areas of specialty/work
Street address
NOOR EYE HOSPITAL, 96 ESFANDIAR ST, VALI-E-ASR ST
City
TEHRAN
Postal code
Phone
+98 21 82400
Fax
Email
ahedayatfar@norc.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)