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An Open-Label Extension of a Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca

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ClinicalTrials.gov Identifier: NCT02845674
Recruitment Status : Completed
First Posted : July 27, 2016
Results First Posted : December 14, 2018
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Global FZE

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Keratoconjunctivitis Sicca
Intervention Drug: OTX-101 0.09%
Enrollment 258
Recruitment Details  
Pre-assignment Details Group 1 and Group 2 consisted of subsets of subjects who received masked treatment with OTX-101 0.09% or with Vehicle, respectively, in OTX-101-2016-001. All subjects received open-label treatment with OTX-101 0.09% in OTX-101-2016-002.
Arm/Group Title OTX-101 0.09% to OTX-101 0.09% Vehicle to OTX-101 0.09%
Hide Arm/Group Description One drop in each eye BID One drop in each eye BID
Period Title: Overall Study
Started 129 129
Completed 111 79
Not Completed 18 50
Arm/Group Title Group 1 Group 2 Total
Hide Arm/Group Description

0.09% cyclosporine nanomicellar solution

OTX-101 0.09%: 0.09% cyclosporine nanomicellar solution

OTX-101 0.09%: 0.09% cyclosporine nanomicellar solution Total of all reporting groups
Overall Number of Baseline Participants 129 129 258
Hide Baseline Analysis Population Description
Intent to treat population; Group 1 and Group 2 consisted of subsets of subjects who received masked treatment with OTX-101 0.09% or with Vehicle, respectively, in OTX-101-2016-001. All subjects received open-label treatment with OTX-101 0.09% in OTX-101-2016-002
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 129 participants 129 participants 258 participants
58.4  (15.51) 61.5  (14.21) 60.0  (14.92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants 129 participants 258 participants
Female
109
  84.5%
107
  82.9%
216
  83.7%
Male
20
  15.5%
22
  17.1%
42
  16.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants 129 participants 258 participants
Hispanic or Latino
18
  14.0%
8
   6.2%
26
  10.1%
Not Hispanic or Latino
111
  86.0%
121
  93.8%
232
  89.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants 129 participants 258 participants
American Indian or Alaska Native
1
   0.8%
0
   0.0%
1
   0.4%
Asian
3
   2.3%
3
   2.3%
6
   2.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.8%
1
   0.4%
Black or African American
12
   9.3%
13
  10.1%
25
   9.7%
White
111
  86.0%
110
  85.3%
221
  85.7%
More than one race
2
   1.6%
2
   1.6%
4
   1.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Adverse Events
Hide Description Number of subjects reporting any AEs
Time Frame 40 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population: Group 1 and Group 2 consisted of subsets of subjects who received masked treatment with OTX-101 0.09% or with Vehicle, respectively, in OTX-101-2016-001. All subjects received open-label treatment with OTX-101 0.09% in OTX-101-2016-002.
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
OTX-101 0.09%: 0.09% cyclosporine nanomicellar solution
OTX-101 0.09%: 0.09% cyclosporine nanomicellar solution
Overall Number of Participants Analyzed 129 129
Measure Type: Number
Unit of Measure: Count of participants
68 81
Time Frame Day 448
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description OTX-101 0.09%: 0.09% cyclosporine nanomicellar solution OTX-101 0.09%: 0.09% cyclosporine nanomicellar solution
All-Cause Mortality
Group 1 Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/129 (0.00%)      0/129 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 Group 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/129 (3.10%)      4/129 (3.10%)    
Injury, poisoning and procedural complications     
Wound dehiscence   1/129 (0.78%)  0/129 (0.00%) 
Femur fracture   0/129 (0.00%)  1/129 (0.78%) 
Metabolism and nutrition disorders     
Dehydration   1/129 (0.78%)  0/129 (0.00%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis   2/129 (1.55%)  2 1/129 (0.78%)  1
Osteoarthritis   0/129 (0.00%)  1/129 (0.78%)  2
Nervous system disorders     
Cerebrovascular accident   0/129 (0.00%)  2/129 (1.55%)  2
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Group 1 Group 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   55/129 (42.64%)      69/129 (53.49%)    
Cardiac disorders     
Atrial fibrillation   2/129 (1.55%)  0/129 (0.00%) 
Eye disorders     
Conjunctival hyperaemia   12/129 (9.30%)  14/129 (10.85%) 
Vitreous detachment   5/129 (3.88%)  2/129 (1.55%) 
Posterior capsule opacification   5/129 (3.88%)  1/129 (0.78%) 
Blepharitis   3/129 (2.33%)  4/129 (3.10%) 
Punctate keratitis   12/129 (9.30%)  4/129 (3.10%) 
Eye irritation   2/129 (1.55%)  2/129 (1.55%) 
Conjunctival haemorrhage   2/129 (1.55%)  2/129 (1.55%) 
Cataract   2/129 (1.55%)  0/129 (0.00%) 
Cataract nuclear   2/129 (1.55%)  0/129 (0.00%) 
Eye allergy   2/129 (1.55%)  0/129 (0.00%) 
Retinal haemorrhage   2/129 (1.55%)  0/129 (0.00%) 
Visual acuity reduced   2/129 (1.55%)  0/129 (0.00%) 
General disorders     
Instillation site reaction   1/129 (0.78%)  3/129 (2.33%) 
Instillation site lacrimation   1/129 (0.78%)  3/129 (2.33%) 
Instillation site pruritus   0/129 (0.00%)  1/129 (0.78%) 
Instillation site pain   17/129 (13.18%)  42/129 (32.56%) 
Investigations     
Intraocular pressure increased   2/129 (1.55%)  1/129 (0.78%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Name/Title: SPARC
Organization: Sun Pharma Advanced Research Company Limited
Phone: +912266455645
Responsible Party: Sun Pharma Global FZE
ClinicalTrials.gov Identifier: NCT02845674     History of Changes
Other Study ID Numbers: OTX-101-2016-002
First Submitted: July 24, 2016
First Posted: July 27, 2016
Results First Submitted: November 14, 2018
Results First Posted: December 14, 2018
Last Update Posted: December 14, 2018