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Trial record 23 of 413 for:    sodium phosphate

Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model

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ClinicalTrials.gov Identifier: NCT01534195
Recruitment Status : Completed
First Posted : February 16, 2012
Results First Posted : January 15, 2019
Last Update Posted : March 26, 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 Allergic Conjunctivitis
Interventions Drug: Prednisolone Sodium Phosphate Ophthalmic Solution 1%
Drug: Tears Naturale II Ophthalmic Solution
Enrollment 11
Recruitment Details  
Pre-assignment Details  
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 (QID) for 8 days.

Tears Naturale II Ophthalmic Solution, 1%

Tears Naturale II Ophthalmic Solution: one drop in each eye QID for 8 days

Period Title: Overall Study
Started 5 6
Completed 4 5
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             1
Arm/Group Title Prednisolone Placebo Total
Hide Arm/Group Description

Prednisolone Sodium Phosphate Ophthalmic Solution, 1%

Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye QID for 8 days.

Tears Naturale II Ophthalmic Solution, 1%

Tears Naturale II Ophthalmic Solution: one drop in each eye QID for 8 days

Total of all reporting groups
Overall Number of Baseline Participants 4 5 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
4
  80.0%
8
  88.9%
>=65 years
0
   0.0%
1
  20.0%
1
  11.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 5 participants 9 participants
49.6  (6.693) 49.5  (13.329) 49.55  (8.896)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
Female
2
  50.0%
3
  60.0%
5
  55.6%
Male
2
  50.0%
2
  40.0%
4
  44.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 5 participants 9 participants
4 5 9
1.Primary Outcome
Title Ocular Itching Change From Baseline to Day 11
Hide Description Ocular itching, as assessed by the participant, was measured on a 4-point scale 5 minutes after the conjunctival allergen challenge (CAC). 0 was best (no itching), and 4 was worst (worst itching).
Time Frame 5 minutes post-CAC
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the study
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 QID for 8 days.

Tears Naturale II Ophthalmic Solution, 1%

Tears Naturale II Ophthalmic Solution: one drop in each eye QID for 8 days

Overall Number of Participants Analyzed 4 5
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.1  (0.14) -0.45  (0.86)
2.Secondary Outcome
Title Conjunctival Redness Change From Baseline to Day 11
Hide Description Conjunctival Redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (no redness), and 4 was worst (most redness)
Time Frame 7 Minutes post-CAC
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the study
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 QID for 8 days.

Tears Naturale II Ophthalmic Solution, 1%

Tears Naturale II Ophthalmic Solution: one drop in each eye QID for 8 days

Overall Number of Participants Analyzed 4 5
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.69  (0.31) 0.40  (0.88)
3.Secondary Outcome
Title Episcleral Redness Change From Baseline to Day 6
Hide Description Episcleral redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC.0 was best (least redness), and 4 was worst (most redness).
Time Frame 7 minutes post-CAC
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the study
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 QID for 8 days.

Tears Naturale II Ophthalmic Solution, 1%

Tears Naturale II Ophthalmic Solution: one drop in each eye QID for 8 days

Overall Number of Participants Analyzed 4 5
Mean (Standard Deviation)
Unit of Measure: score on a scale
-1.0  (0.41) 0.45  (0.93)
4.Secondary Outcome
Title Ciliary Redness Change From Baseline to Day 6
Hide Description Ciliary redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (least redness), and 4 was worst (most redness).
Time Frame 7 minutes post-CAC
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the study
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 QID for 8 days.

Tears Naturale II Ophthalmic Solution, 1%

Tears Naturale II Ophthalmic Solution: one drop in each eye QID for 8 days

Overall Number of Participants Analyzed 4 5
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.94  (0.66) 0.30  (0.96)
Time Frame AEs were collected from the date of informed consent to the date of the final visit (1 month).
Adverse Event Reporting Description [Not Specified]
 
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 8 days.

Tears Naturale II Ophthalmic Solution, 1%

Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 8 days

All-Cause Mortality
Prednisolone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)      0/6 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Prednisolone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      0/6 (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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/5 (20.00%)      3/6 (50.00%)    
Eye disorders     
Mucous Discharge (OU)   0/5 (0.00%)  0 2/6 (33.33%)  2
Musculoskeletal and connective tissue disorders     
Headache   1/5 (20.00%)  1 0/6 (0.00%)  0
Backache   0/5 (0.00%)  0 1/6 (16.67%)  1
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: 9786896500
EMail: klane@oraclinical.com
Layout table for additonal information
Responsible Party: ORA, Inc.
ClinicalTrials.gov Identifier: NCT01534195     History of Changes
Other Study ID Numbers: 12-270-0001
First Submitted: January 25, 2012
First Posted: February 16, 2012
Results First Submitted: December 27, 2018
Results First Posted: January 15, 2019
Last Update Posted: March 26, 2019