Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca (Emerald)
|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: NCT02688556|
Recruitment Status : Completed
First Posted : February 23, 2016
Results First Posted : April 8, 2019
Last Update Posted : November 19, 2021
|Condition or disease||Intervention/treatment||Phase|
|Keratoconjunctivitis Sicca||Drug: cyclosporine Drug: vehicle of OTX-101||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||745 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca|
|Actual Study Start Date :||February 2016|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||December 2016|
Experimental: OTX-101 0.09%
0.09% cyclosporine nanomicellar ophthalmic solution
Other Name: Seciera
Placebo Comparator: Vehicle
vehicle of OTX-101
Drug: vehicle of OTX-101
- Tear Production [ Time Frame: Baseline and 12 weeks ]Percentage of Eyes with Increase from Baseline of ≥ 10 mm in Schirmer's Test Score
- Conjunctival Staining [ Time Frame: Baseline and 12 weeks ]
change from baseline in total conjunctival staining score (lissamine green, modified National Eye Institute scale) at 12 weeks.
Conjunctival Lissamine Green Staining Grades ranged from 0 (No punctate stain in zone) to 3 (Densely concentrated micropunctate stain spots)
- Central Corneal Staining [ Time Frame: Baseline and 12 weeks ]
change from baseline in central corneal staining score (fluorescein, modified NEI/FDA scale) at 12 weeks.
The Expanded National Eye Institute (NEI)/Industry Workshop Scale for Corneal Staining Score was used to grade each of the 5 areas of the cornea on a 0 (No punctate stain in area) to 4 (Severe diffuse (coalescent) macropunctate stain of the area) scale.
- Symptom Score [ Time Frame: Baseline and 12 weeks ]
change from baseline in modified Symptom Assessment in Dry Eye (SANDE) score at 12 weeks.
A modified SANDE instrument was used to evaluate dry eye symptoms at each visit.
Subjects were asked to indicate:
- frequency of dry and irritated eyes on a scale of 0 (rarely) to 100 (all the time); and
- severity of dry eyes on a scale of 0 (very mild) to 100 (severe) The global symptom score is the square root of the frequency score times the severity score and will be completed at each visit. (range 0 to 100)
Negative change from baseline indicates improvement.
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): NCT02688556
|United States, California|
|Martel Eye Medical Group|
|Rancho Cordova, California, United States, 95670|
|United States, Kentucky|
|Cincinnati Eye Institute|
|Edgewood, Kentucky, United States, 41017|
|United States, New York|
|Fifth Avenue Eye Associates|
|New York, New York, United States, 10028|