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

• Sponsor: Sun Pharmaceutical Industries Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02845674
• Collaborator: (none)
• Enrollment: 258
• Arm: 1
• Actual Duration (Months): 12.6

Study Details

Study Description

Brief Summary

This is a safety extension enrolling subjects participating in Study OTX-101-2016-001 (NCT02688556)

Condition or Disease	Intervention/Treatment	Phase
Keratoconjunctivitis Sicca	Drug: OTX-101 0.09%	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 258 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label Extension of 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: Jul 29, 2016
• Actual Primary Completion Date: Aug 15, 2017
• Actual Study Completion Date: Aug 15, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OTX-101 0.09% 0.09% cyclosporine nanomicellar solution	Drug: OTX-101 0.09%; 0.09% cyclosporine nanomicellar solution; Other Names: Seciera

Outcome Measures

Primary Outcome Measures

1. Adverse Events [40 weeks]

   Number of subjects reporting any AEs

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Completion of Study OTX-101-2016-001

Exclusion Criteria:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Sun Pharmaceutical Industries Limited

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Mar 23, 2017
• Statistical Analysis Plan - Oct 10, 2017

More Information

Publications

None provided.

• Responsible Party: Sun Pharmaceutical Industries Limited
• ClinicalTrials.gov Identifier: NCT02845674
• Other Study ID Numbers: OTX-101-2016-002
• First Posted: Jul 27, 2016
• Last Update Posted: Nov 19, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Keratoconjunctivitis; Keratoconjunctivitis Sicca; Dry Eye Syndromes

Study Results

Participant Flow

Pre-assignment Detail	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%
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

Baseline Characteristics

Arm/Group Title	Group 1	Group 2	Total
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 Participants	129	129	258
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.4 (15.51)	61.5 (14.21)	60.0 (14.92)
Sex: Female, Male (Count of Participants)
Female	109 84.5%	107 82.9%	216 83.7%
Male	20 15.5%	22 17.1%	42 16.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	18 14%	8 6.2%	26 10.1%
Not Hispanic or Latino	111 86%	121 93.8%	232 89.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.8%	0 0%	1 0.4%
Asian	3 2.3%	3 2.3%	6 2.3%
Native Hawaiian or Other Pacific Islander	0 0%	1 0.8%	1 0.4%
Black or African American	12 9.3%	13 10.1%	25 9.7%
White	111 86%	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%

Outcome Measures

1. Primary Outcome

Title	Adverse Events
Description	Number of subjects reporting any AEs
Time Frame	40 weeks

Outcome Measure Data

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
Arm/Group Description	OTX-101 0.09%: 0.09% cyclosporine nanomicellar solution	OTX-101 0.09%: 0.09% cyclosporine nanomicellar solution
Measure Participants	129	129
Number [Count of participants]	68 52.7%	81 62.8%

Adverse Events

Time Frame	Day 448
Arm/Group Title	Group 1		Group 2
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/129 (0%)		0/129 (0%)
Serious Adverse Events
	Group 1		Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/129 (3.1%)		4/129 (3.1%)
Injury, poisoning and procedural complications
Wound dehiscence	1/129 (0.8%)		0/129 (0%)
Femur fracture	0/129 (0%)		1/129 (0.8%)
Metabolism and nutrition disorders
Dehydration	1/129 (0.8%)		0/129 (0%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	2/129 (1.6%)	2	1/129 (0.8%)	1
Osteoarthritis	0/129 (0%)		1/129 (0.8%)	2
Nervous system disorders
Cerebrovascular accident	0/129 (0%)		2/129 (1.6%)	2
Other (Not Including Serious) Adverse Events
	Group 1		Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	55/129 (42.6%)		69/129 (53.5%)
Cardiac disorders
Atrial fibrillation	2/129 (1.6%)		0/129 (0%)
Eye disorders
Conjunctival hyperaemia	12/129 (9.3%)		14/129 (10.9%)
Vitreous detachment	5/129 (3.9%)		2/129 (1.6%)
Posterior capsule opacification	5/129 (3.9%)		1/129 (0.8%)
Blepharitis	3/129 (2.3%)		4/129 (3.1%)
Punctate keratitis	12/129 (9.3%)		4/129 (3.1%)
Eye irritation	2/129 (1.6%)		2/129 (1.6%)
Conjunctival haemorrhage	2/129 (1.6%)		2/129 (1.6%)
Cataract	2/129 (1.6%)		0/129 (0%)
Cataract nuclear	2/129 (1.6%)		0/129 (0%)
Eye allergy	2/129 (1.6%)		0/129 (0%)
Retinal haemorrhage	2/129 (1.6%)		0/129 (0%)
Visual acuity reduced	2/129 (1.6%)		0/129 (0%)
General disorders
Instillation site reaction	1/129 (0.8%)		3/129 (2.3%)
Instillation site lacrimation	1/129 (0.8%)		3/129 (2.3%)
Instillation site pruritus	0/129 (0%)		1/129 (0.8%)
Instillation site pain	17/129 (13.2%)		42/129 (32.6%)
Investigations
Intraocular pressure increased	2/129 (1.6%)		1/129 (0.8%)

Limitations/Caveats

[Not Specified]

More Information

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.