Trial · NCT02688556
Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
NCT02688556, Phase 3, Completed, Sun Pharmaceutical Industries Limited; results first posted 2019-04-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca. Trials, record NCT02688556. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02688556
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
- NCT number
- NCT02688556
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 745 participants, actual
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Conditions
- Keratoconjunctivitis Sicca
- Interventions
- cyclosporine, vehicle of OTX-101
- First posted
- 2016-02-23
- Last updated
- 2022-08-29
- Results first posted
- 2019-04-08
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tear Production | Baseline and 12 weeks | Percentage of Eyes with Increase from Baseline of ≥ 10 mm in Schirmer's Test Score |
| Secondary | Conjunctival Staining | 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) |
| Secondary | Central Corneal Staining | 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. |
| Secondary | Symptom Score | 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: 1. frequency of dry and irritated eyes on a scale of 0 (rarely) to 100 (all the time); and 2. 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Tear Production | Baseline and 12 weeks | Intent to treat population | Percentage of eyes | NUMBER |
| SECONDARY | Conjunctival Staining | Baseline and 12 weeks | Intent to treat population | score on a scale | MEAN |
| SECONDARY | Central Corneal Staining | Baseline and 12 weeks | Intent to treat population | score on a scale | MEAN |
| SECONDARY | Symptom Score | Baseline and 12 weeks | Intent to treat population | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Tear Production | OTX-101 0.09% | 16.6 | Percentage of eyes | ||
| Tear Production | Vehicle | 9.2 | Percentage of eyes | ||
| Conjunctival Staining | OTX-101 0.09% | -1.53 | Standard Deviation 1.927 | score on a scale | |
| Conjunctival Staining | Vehicle | -1.16 | Standard Deviation 2.2064 | score on a scale | |
| Central Corneal Staining | OTX-101 0.09% | -0.28 | Standard Deviation 0.533 | score on a scale | |
| Central Corneal Staining | Vehicle | -0.26 | Standard Deviation 0.588 | score on a scale | |
| Symptom Score | OTX-101 0.09% | -18.8 | Standard Deviation 24.08 | score on a scale | |
| Symptom Score | Vehicle | -19.1 | Standard Deviation 23.14 | score on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | OTX-101 0.09% | 372 | |
| Overall Study | STARTED | Vehicle | 373 | |
| Overall Study | COMPLETED | OTX-101 0.09% | 347 | |
| Overall Study | COMPLETED | Vehicle | 361 | |
| Overall Study | NOT COMPLETED | OTX-101 0.09% | 25 | |
| Overall Study | NOT COMPLETED | Vehicle | 12 |
Source ClinicalTrials.gov
Adverse events44
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Conjunctival hyperaemia | Eye disorders | OTX-101 0.09% | 30 | 372 | |
| other | Conjunctival hyperaemia | Eye disorders | Vehicle | 18 | 372 | |
| other | Blepharitis | Eye disorders | OTX-101 0.09% | 5 | 372 | |
| other | Blepharitis | Eye disorders | Vehicle | 0 | 372 | |
| other | Eye irritation | Eye disorders | OTX-101 0.09% | 3 | 372 | |
| other | Eye irritation | Eye disorders | Vehicle | 5 | 372 | |
| other | Eye pruritus | Eye disorders | OTX-101 0.09% | 1 | 372 | |
| other | Eye pruritus | Eye disorders | Vehicle | 5 | 372 | |
| other | Instillation site pain | General disorders | OTX-101 0.09% | 90 | 372 | |
| other | Instillation site pain | General disorders | Vehicle | 16 | 372 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OTX-101 0.09% | 1 | 372 |
| Total, all-cause mortality | Vehicle | 0 | 372 |
| Total, other adverse events | OTX-101 0.09% | 130 | 372 |
| Total, other adverse events | Vehicle | 66 | 372 |
| Total, serious adverse events | OTX-101 0.09% | 6 | 372 |
| Total, serious adverse events | Vehicle | 2 | 372 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| OTX-101 0.09% vs Vehicle: deaths from any cause | Trial comparisons |
| OTX-101 0.09% vs Vehicle: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02688556
GET https://conductscience.org/api/trials/v1/NCT02688556/events?page=2