Trial · NCT02961062

Study of SAF312 as an Eye Drop for Treatment of Eye Pain Following Photorefractive Keratectomy (PRK) Surgery

NCT02961062, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2019-04-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of SAF312 as an Eye Drop for Treatment of Eye Pain Following Photorefractive Keratectomy (PRK) Surgery. Trials, record NCT02961062. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02961062

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of SAF312 as an Eye Drop for Treatment of Eye Pain Following Photorefractive Keratectomy (PRK) Surgery
NCT number: NCT02961062
Status: Completed
Phases: Phase 2
Enrollment: 40 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Postoperative Ocular Pain After PRK Surgery
Interventions: SAF312, Placebo
First posted: 2016-11-10
Last updated: 2021-10-06
Results first posted: 2019-04-11

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Visual Analog Scale (VAS) Pre-dose Pain Assessment	6 hours	VAS pain severity scale pre-dose, 6 hours post-operatively. The Visual Analog Scale (VAS) is a commonly used measurement of pain, discomfort, that goes from 0 meaning no pain to 100 meaning worst imaginable pain
Primary	Average Ocular Pain VAS Assessments	12 hours	VAS pain severity scale from the first post-operative assessment to pre-dose 12 hours post-operative assesment The Visual Analog Scale (VAS) is a commonly used measurement of pain, discomfort, that goes from 0 meaning no pain to 100 meaning worst imaginable pain
Secondary	Incidence of and Amount of Rescue Oral Analgesics (Number of Participants Who Did Not Use Oral Rescue Medication)	6,12, 24, 48 and 72 hours post-operatievly	Summary of oral rescue medication use incidence (number of patients who DID NOT use oral rescue medication)
Secondary	VAS Pain Assessments	72 hours	VAS pain assessment during the first 72 hours post-operatively. VAS pain severity scale from the first post-operative assessment to pre-dose 12 hours post-operative assesment The Visual Analog Scale (VAS) is a commonly used measurement of pain, discomfort, that goes from 0 meaning no pain to 100 meaning worst imaginable pain
Secondary	Plasma Concentration of SAF312	day1, day 4	C Max

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Visual Analog Scale (VAS) Pre-dose Pain Assessment	6 hours	Primary PD Analysis set	score on a scale	MEAN
PRIMARY	Average Ocular Pain VAS Assessments	12 hours	Primary PD Analysis set	score on a scale	MEAN
SECONDARY	Incidence of and Amount of Rescue Oral Analgesics (Number of Participants Who Did Not Use Oral Rescue Medication)	6,12, 24, 48 and 72 hours post-operatievly	Secondary PD analysis set	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	VAS Pain Assessments	72 hours	Primary PD Analysis set	score on a scale	MEAN
SECONDARY	Plasma Concentration of SAF312	day1, day 4	PK Analysis set	ng/mL	MEAN

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Visual Analog Scale (VAS) Pre-dose Pain Assessment	SAF312		34.63	Standard Error 4.05	score on a scale
Visual Analog Scale (VAS) Pre-dose Pain Assessment	Vehicle		45.76	Standard Error 4.10	score on a scale
Average Ocular Pain VAS Assessments	SAF312		30.90	Standard Error 4.07	score on a scale
Average Ocular Pain VAS Assessments	Vehicle		39.47	Standard Error 4.11	score on a scale
Incidence of and Amount of Rescue Oral Analgesics (Number of Participants Who Did Not Use Oral Rescue Medication)	SAF312	0-6 hours post-operatively	23		Participants
Incidence of and Amount of Rescue Oral Analgesics (Number of Participants Who Did Not Use Oral Rescue Medication)	Vehicle	0-6 hours post-operatively	19		Participants
Incidence of and Amount of Rescue Oral Analgesics (Number of Participants Who Did Not Use Oral Rescue Medication)	SAF312	0-12 hours post-operatively	19		Participants
Incidence of and Amount of Rescue Oral Analgesics (Number of Participants Who Did Not Use Oral Rescue Medication)	Vehicle	0-12 hours post-operatively	16		Participants
Incidence of and Amount of Rescue Oral Analgesics (Number of Participants Who Did Not Use Oral Rescue Medication)	SAF312	0-24 hours post-operatively	16		Participants
Incidence of and Amount of Rescue Oral Analgesics (Number of Participants Who Did Not Use Oral Rescue Medication)	Vehicle	0-24 hours post-operatively	12		Participants

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Treatment Sequence 1	20
Overall Study	STARTED	Treatment Sequence 2	20
Overall Study	COMPLETED	Treatment Sequence 1	20
Overall Study	COMPLETED	Treatment Sequence 2	20
Overall Study	NOT COMPLETED	Treatment Sequence 1	0
Overall Study	NOT COMPLETED	Treatment Sequence 2	0

Source ClinicalTrials.gov

Adverse events26

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
other	Tinnitus	Ear and labyrinth disorders	SAF312	0	40
other	Tinnitus	Ear and labyrinth disorders	Vehicle	1	40
other	Corneal infiltrates	Eye disorders	SAF312	0	40
other	Corneal infiltrates	Eye disorders	Vehicle	1	40
other	Corneal opacity	Eye disorders	SAF312	1	40
other	Corneal opacity	Eye disorders	Vehicle	1	40
other	Punctate keratitis	Eye disorders	SAF312	1	40
other	Punctate keratitis	Eye disorders	Vehicle	1	40
other	Vitreous detachment	Eye disorders	SAF312	1	40
other	Vitreous detachment	Eye disorders	Vehicle	0	40

1 to 10 of 26Source ClinicalTrials.gov

See all 26 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	SAF312	0	40
Total, all-cause mortality	Vehicle	0	40
Total, other adverse events	SAF312	8	40
Total, other adverse events	Vehicle	5	40
Total, serious adverse events	SAF312	0	40
Total, serious adverse events	Vehicle	0	40

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36729473	DERIVED

Source PubMed

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
SAF312 vs Vehicle: deaths from any cause	Trial comparisons
SAF312 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02961062

GET https://conductscience.org/api/trials/v1/NCT02961062/events?page=2

API reference For AI assistants