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Trial record 20 of 410 for:    sodium phosphate

Evaluation of Prednisolone in a Modified Conjunctival Allergen Challenge Model

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ClinicalTrials.gov Identifier: NCT01730872
Recruitment Status : Completed
First Posted : November 21, 2012
Results First Posted : June 19, 2019
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
ORA, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Chronic Allergic Conjunctivitis
Interventions Drug: Prednisolone Sodium Phosphate Ophthalmic Solution 1%
Drug: Tears Naturale II Ophthalmic Solution
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Prednisolone Placebo Control
Hide Arm/Group Description

Prednisolone Sodium Phosphate Ophthalmic Solution, 1%

Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days.

Tears Naturale II Ophthalmic Solution, 1%

Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days

Subjects received CAC using saline instead of allergen
Period Title: Overall Study
Started 8 5 3
Full Analysis Set 8 4 [1] 0
Completed 8 5 3
Not Completed 0 0 0
[1]
1 subject did not complete the last post-CAE measurement on Day 6 and was excluded from the FAS
Arm/Group Title Prednisolone Placebo Saline Total
Hide Arm/Group Description

Prednisolone Sodium Phosphate Ophthalmic Solution, 1%

Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days.

Tears Naturale II Ophthalmic Solution, 1%

Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days

A group of three allergic subjects will be challenged with saline only to evaluate the impact of confocal microscopy on ocular signs and symptoms in the absence of allergic challenge. These five subjects will receive placebo in an open label fashion and will not require randomization. Total of all reporting groups
Overall Number of Baseline Participants 8 5 3 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 5 participants 3 participants 16 participants
41.75  (1.461897) 37.2  (1.830301) 39.33  (0.905539) 39.88  (0.0707107)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 5 participants 3 participants 16 participants
Female
3
  37.5%
2
  40.0%
2
  66.7%
7
  43.8%
Male
5
  62.5%
3
  60.0%
1
  33.3%
9
  56.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 5 participants 3 participants 16 participants
American Indian or Alaska Native
0
   0.0%
1
  20.0%
0
   0.0%
1
   6.3%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  12.5%
0
   0.0%
0
   0.0%
1
   6.3%
White
6
  75.0%
4
  80.0%
3
 100.0%
13
  81.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  12.5%
0
   0.0%
0
   0.0%
1
   6.3%
1.Primary Outcome
Title Inflammation Change From Baseline to Day 6
Hide Description Ocular inflammation was measured by a masked clinician on a 4-point scale 90 minutes after the conjunctival allergen challenge (CAC) . 0 = best (little to no inflammation), 4 = worst (most inflammation).
Time Frame 90 minutes post CAC
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol (PP) population will comprise all subjects in the ITT population without protocol deviations.
Arm/Group Title Prednisolone Placebo
Hide Arm/Group Description:

Prednisolone Sodium Phosphate Ophthalmic Solution, 1%

Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days.

Tears Naturale II Ophthalmic Solution, 1%

Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days

Overall Number of Participants Analyzed 8 4
Mean (Standard Deviation)
Unit of Measure: score on a scale
-1.2  (0.78) -0.19  (0.43)
2.Secondary Outcome
Title Ocular Itching Change From Baseline to Day 6
Hide Description Ocular itching was measured by subject on a scale of 0 to 4 where 0 = no itching and 4 = worst itching. This measurement was taken 7 minutes post CAC
Time Frame 7 minutes post-CAC
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol (PP) population will comprise all subjects in the ITT population without protocol deviations.
Arm/Group Title Prednisolone Placebo
Hide Arm/Group Description:

Prednisolone Sodium Phosphate Ophthalmic Solution, 1%

Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days.

Tears Naturale II Ophthalmic Solution, 1%

Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days

Overall Number of Participants Analyzed 8 4
Mean (Standard Deviation)
Unit of Measure: score on a scale
-1.1  (1.30) -1.0  (1.29)
3.Secondary Outcome
Title Ocular Redness Change From Baseline to Day 6
Hide Description Ocular redness was measured by the investigator on a 4-point scale 7 minutes post-CAC. 0 = best (no redness), 4 = worst (most redness).
Time Frame 7 minutes post-CAC
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol (PP) population will comprise all subjects in the ITT population without protocol deviations.
Arm/Group Title Prednisolone Placebo
Hide Arm/Group Description:

Prednisolone Sodium Phosphate Ophthalmic Solution, 1%

Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days.

Tears Naturale II Ophthalmic Solution, 1%

Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days

Overall Number of Participants Analyzed 8 4
Mean (Standard Deviation)
Unit of Measure: score on a scale
-1.1  (1.38) 0.31  (1.01)
Time Frame AEs were collected from the signing of the informed consent form to the end of the study (approximately 2 weeks).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Prednisolone Placebo Saline
Hide Arm/Group Description

Prednisolone Sodium Phosphate Ophthalmic Solution, 1%

Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days.

Tears Naturale II Ophthalmic Solution, 1%

Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days

A group of five allergic subjects will be challenged with saline only to evaluate the impact of confocal microscopy on ocular signs and symptoms in the absence of allergic challenge. These five subjects will receive placebo in an open label fashion and will not require randomization.
All-Cause Mortality
Prednisolone Placebo Saline
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)      0/5 (0.00%)      0/3 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Prednisolone Placebo Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/5 (0.00%)      0/3 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Prednisolone Placebo Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/8 (25.00%)      1/5 (20.00%)      0/3 (0.00%)    
Eye disorders       
peri-ocular lid redness   1/8 (12.50%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0
endothelial pigment   0/8 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0
Musculoskeletal and connective tissue disorders       
lower leg pain   1/8 (12.50%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Keith Lane
Organization: Ora
Phone: 9786858900
EMail: klane@oraclinical.com
Layout table for additonal information
Responsible Party: ORA, Inc.
ClinicalTrials.gov Identifier: NCT01730872     History of Changes
Other Study ID Numbers: 12-270-0007
First Submitted: November 15, 2012
First Posted: November 21, 2012
Results First Submitted: December 27, 2018
Results First Posted: June 19, 2019
Last Update Posted: June 19, 2019