Trial · NCT01109056

Safety and Efficacy of Cyclosporine Ophthalmic Emulsion in Patients With Primary Pterygium

NCT01109056, Phase 2, Completed, Allergan; results first posted 2012-06-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Cyclosporine Ophthalmic Emulsion in Patients With Primary Pterygium. Trials, record NCT01109056. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01109056

On this page

Trial

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

Title: Safety and Efficacy of Cyclosporine Ophthalmic Emulsion in Patients With Primary Pterygium
NCT number: NCT01109056
Status: Completed
Phases: Phase 2
Enrollment: 115 participants, actual
Lead sponsor: Allergan
Conditions: Pterygium
Interventions: cyclosporine ophthalmic emulsion 0.05%, Vehicle
First posted: 2010-04-22
Last updated: 2012-06-25
Results first posted: 2012-06-25

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Number of Pterygium Hyperemia Responders at Week 16	Week 16	Number of pterygium hyperemia responders at Week 16 as measured by the Pterygium Hyperemia Grading Scale. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A responder is defined as a patient demonstrating at least a 2-grade decrease from baseline in pterygium hyperemia.
Primary	Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16	Baseline, Week 16	Change from Baseline in Severity Grade of Pterygium Hyperemia at Week 16. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A negative number change from baseline is an improvement and a positive number change from baseline is a worsening.
Secondary	Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16	Baseline, Week 16	Change from baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire score at Week 16. The OSDI© is a 12-question survey for patients to document their dry eye disease symptoms. Each question is rated on a 5-point scale (0=none of the time and 4 = all of the time). The scores are totaled over the 12 questions and normalized/converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Pterygium Hyperemia Responders at Week 16	Week 16	Modified Intent to Treat:~All randomized patients who received study treatment and had a baseline and at least one post-baseline assessment of pterygium hyperemia	Participants	NUMBER
PRIMARY	Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16	Baseline, Week 16	Modified Intent to Treat:~All randomized patients who received study treatment and had a baseline and at least one post-baseline assessment of pterygium hyperemia	Scores on a Scale	MEAN
SECONDARY	Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16	Baseline, Week 16	Modified Intent to Treat: All randomized patients who received study treatment and had a baseline and at least one post-baseline assessment of pterygium hyperemia	Scores on a Scale	MEAN

Source ClinicalTrials.gov

Results by group10

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

Outcome	Group	Category	Value	Spread	Units
Number of Pterygium Hyperemia Responders at Week 16	Cyclosporine Ophthalmic Emulsion 0.05%		6		Participants
Number of Pterygium Hyperemia Responders at Week 16	Vehicle		8		Participants
Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16	Cyclosporine Ophthalmic Emulsion 0.05%	Baseline	3.1	Standard Deviation 0.35	Scores on a Scale
Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16	Vehicle	Baseline	3.2	Standard Deviation 0.37	Scores on a Scale
Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16	Cyclosporine Ophthalmic Emulsion 0.05%	Change from Baseline at Week 16	-0.7	Standard Deviation 0.76	Scores on a Scale
Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16	Vehicle	Change from Baseline at Week 16	-0.8	Standard Deviation 0.75	Scores on a Scale
Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16	Cyclosporine Ophthalmic Emulsion 0.05%	Baseline	20.2	Standard Deviation 16.97	Scores on a Scale
Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16	Vehicle	Baseline	29.3	Standard Deviation 26.89	Scores on a Scale
Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16	Cyclosporine Ophthalmic Emulsion 0.05%	Change from Baseline at Week 16	-3.1	Standard Deviation 14.95	Scores on a Scale
Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16	Vehicle	Change from Baseline at Week 16	-10.5	Standard Deviation 16.02	Scores on a Scale

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Cyclosporine Ophthalmic Emulsion 0.05%	57
Overall Study	STARTED	Vehicle	58
Overall Study	COMPLETED	Cyclosporine Ophthalmic Emulsion 0.05%	50
Overall Study	COMPLETED	Vehicle	53
Overall Study	NOT COMPLETED	Cyclosporine Ophthalmic Emulsion 0.05%	7
Overall Study	NOT COMPLETED	Vehicle	5

Source ClinicalTrials.gov

Adverse events18

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	Eye Irritation	Eye disorders	Cyclosporine Ophthalmic Emulsion 0.05%	4	56
other	Eye Irritation	Eye disorders	Vehicle	3	58
other	Conjunctival hyperaemia	Eye disorders	Cyclosporine Ophthalmic Emulsion 0.05%	4	56
other	Conjunctival hyperaemia	Eye disorders	Vehicle	2	58
other	Eye Pain	Eye disorders	Cyclosporine Ophthalmic Emulsion 0.05%	3	56
other	Eye Pain	Eye disorders	Vehicle	2	58
other	Instillation Site Pain	General disorders	Cyclosporine Ophthalmic Emulsion 0.05%	3	56
other	Instillation Site Pain	General disorders	Vehicle	2	58
other	Lacrimation Increased	Eye disorders	Cyclosporine Ophthalmic Emulsion 0.05%	3	56
other	Lacrimation Increased	Eye disorders	Vehicle	0	58

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cyclosporine Ophthalmic Emulsion 0.05%
Total, all-cause mortality	Vehicle
Total, other adverse events	Cyclosporine Ophthalmic Emulsion 0.05%	19	56
Total, other adverse events	Vehicle	16	58
Total, serious adverse events	Cyclosporine Ophthalmic Emulsion 0.05%	1	56
Total, serious adverse events	Vehicle	1	58

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
Cyclosporine Ophthalmic Emulsion 0.05% vs Vehicle: Number of Pterygium Hyperemia Responders at Week 16	Trial comparisons
Cyclosporine Ophthalmic Emulsion 0.05% 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/NCT01109056

GET https://conductscience.org/api/trials/v1/NCT01109056/registered

API reference For AI assistants